Frontida is actively recruiting innovative and caring professionals. Here, you can help develop and build a culture of caring, accountability and continuous improvement (both individually and corporately). Frontida careers extend from pharmaceutical formulation scientists to quality assurance specialists, information technology to regulatory compliance professionals, and manufacturing to mechanical specialists. Join a powerful, results-oriented team.

Job Summary

We are seeking an experienced senior scientist to join our Formulation team at our Philadelphia location. The candidate will be responsible for the development and evaluation of new formulations and/or formulation platforms of complex pharmaceutical products such as controlled release, solid oral dosage forms, etc under minimal supervision using established and novel technology.

Responsibilities

  •  Performs in-depth, detailed and complex literature and patent searches to provide background basis for development plans
  • Plans, executes, and assists in the evaluation of formulation development activities
  • Utilize experimental design to rapidly optimize formulation composition and in-process specifications
  • Evaluate product testing results, provide next steps for continued development until finalize product formulation and processes
  • Present product development progress to upper management and project teams
  • Troubleshoot formulation issues that occur during product development, scale-ups and/or in production
  • Develop new formulation concepts. Assists in the development of project plans and business analysis and feasibility assessments
  • Writes, reviews, and approves cGMP documentation including batch records, protocols, SOPs, pharmaceutical development reports etc.
  • Advances process technologies and supports the patent (intellectual property) development
  • Provides mentoring to Formulation Scientists
  • Effectively communicate with cross functional teams like Analytical Development, Quality, PK, Regulatory Affairs and Legal teams
  • Attend SOP, Safety and scientific trainings to remain current with CGMP regulations, safety standards, and development technologies
  • Follow relevant Frontida SOP’s and FDA/ICH guidance
  • Other duties as assigned

Qualifications

  • Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Chemistry or Chemical Engineering with 3 years of experience or a Master’s degree with 5 years’ experience is preferred. Experience with generic drug development is desirable
  • Good understanding of pharmaceutical formulation development principles, QbD, CMC regulation and strong organization skills
  • Excellent written and oral communication skills, critical thinking and interpersonal skills

Knowledge and Skills

  • Strong knowledge of common pharmaceutical raw materials, their applications, and the principles of formulation development
  • Proven experience with statistical design of experiments
  • Strong written and oral communication skills
  • Working knowledge of regulatory requirements, including FDA, EMEA, ICH, and regulations in regards to IIG, GRAS, residual solvents, bioequivalence studies, etc for oral formulations
  • Working knowledge of MS Office (Word, Excel, PowerPoint, Access, and Outlook), Minitab, JMP or equivalent
  • Ability to present technical presentations to management to ensure understanding, responding to complex questions
  • Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

 

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

Establishes the production plans and schedules that meet with business development programs, production capabilities, transportation alternatives and distribution requirements. Ensures that actual production meets scheduled demand requirements. Coordinates materials availability, operations labor resources, documentation to create production plans that are achievable and meet project, order and customer requirements. Monitors production execution throughout the manufacturing cycle to meet requirements. Collaborates closely with Operations and Quality Lab to manage and adjust production orders based on changes in demand and capacity to develop optimal production plans that best meet customer commitments and Frontida business objectives.

Responsibilities

  • Responsible for all production planning. Provide leadership and direction for the production planning function to ensure effective business management through compliance with standards and procedures while meeting production schedules, utilization targets, and on time delivery requirements. Works directly with internal stakeholders to resolve critical materials availability and schedule issues. Monitors and reports status or schedule change to affected parties. Coordinates schedule adjustments with portfolio scheduling.
  • Achieves production planning operational objectives by contributing production planning information and recommendations to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; resolving problems; completing audits; identifying trends; determining system improvements; implementing change.
  • Develops, maintains and monitors processes and procedures. Ensures high quality service, efficient operation, and compliance with established methods/standards. Initiates corrective action as appropriate.
  • Coordinates granulation/blending, coating, and packaging production planning groups to deliver optimally sequenced work plans and production schedules to Operations to align demand to labor capacity, availability – lead time of materials and space to maximize achievement of customer/project/order schedule requirements.
  • Monitors and ensures labor capacity is effectively utilized. Implements metrics to track and improve planning performance, identifies and implements continuous improvement opportunities.
  • Ensures effective monitoring of materials availability and ensures planning works cross-functionally to expedite when necessary to meet production schedules. Leads corrective action when production schedules cannot be executed as planned. Investigate production problem, analyze root causes and provide solutions.
  • Responsible for the on-going management and development of assigned employees. Determines staffing and skill requirements to meet departmental needs, and implements plans to satisfy those requirements.
  • Plan inventory management processes to avoid shortages and excesses. Resolves production scheduling problems by analyzing reports; developing solutions. Provides management control information by collecting, analyzing, and summarizing production data and trends.
  • Must participate and successfully complete all training as required by the company.
  • Perform other duties as assigned.

Qualifications

  • BS Degree in Business, Supply Chain, Logistics or related field
  • 5+ years experience in Production Planning/Scheduling in oral solid forms

Knowledge and Skills

  • Knowledge of plant capacities, equipment, processes and their interaction
  • Working knowledge of cGMP
  • Strong analytical skills
  • Proficient in the use of Microsoft Office and other applications as applicable plus ability to learn company used applications
  • Ability to problem solve with cross functional teams
  • Uses logic, rational thinking, and data to make effective decisions
  • Builds relationships with other functional groups/business units
  • Ability to work independently with minimal supervision
  • Ability to prioritize and act with a sense of urgency
  • Strong listening, written and verbal communication skills
  • Ability to deliver influential messages
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Physical Demands

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear.
  • The employee must on occasions lift and/or move up to 30 pounds for certain job functions.
  • Specific visual abilities include close vision, color vision, peripheral vision, Depth perception and focus.

Work Environment

  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals and disabilities to perform the essential functions.
  • The noise level in the work environment is usually quiet to moderate.
  • Normal office sounds to manufacturing.

Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

HR Specialist provides recruiting and administrative support to Human Resources department. This position helps to create and maintain a positive on boarding experience for all employees/contractors from recruiting through new employee orientation.

Responsibilities

  • Responsible for all initial recruiting of candidates to include job advertising, pre-screening, and setting up interviews with hiring managers for top candidates.
  • Responsible for the on-boarding function of all candidates once final offer is accepted. Including New Employee Orientation, distribution and coordination to the candidate of all required onboarding documents including, but not limited to, employment paperwork, tax forms and background check forms.
  • Monitor and review all returned employment documents for accuracy.
  • Responsible for appropriate follow-up of each element of background screenings within time frames established.
  • Follow-up with appropriate departments/vendors/candidates of stages of process and actions needed.
  • Preparation and tracking of all new hire paperwork including summary form, electronic file,and all required documents, including verification of initial compliance testing and required acknowledgement forms
  • Data entry of employee/contractor personnel data into HR/Payroll system for changes and terminations.
  • Ongoing maintenance of employee/contractor electronic HR files.
  • Assists with special projects.
  • Other duties as assigned.

Qualifications

  • Bachelor’s Degree (Human Resources, Labor Relations or related field)
  • Minimum of two years recent experience as an HR Generalist or recruiting specialist
  • Demonstrated knowledge of federal and state HR regulations
  • Demonstrated knowledge and proficiency of HR processes
  • Work effectively on cross-functional teams
  • Ideal candidate will have strong critical thinking ability, organizational, time management and problem solving skills. Must take ownership and accountability of processes.
  • Ability to drive processes forward in clear, concise and appropriate manner
  • Exceptional attention to detail, accuracy and thoroughness
  • Proven ability to manage competing priorities and multi-task in a high volume environment while adhering to strict deadline
  • Is action oriented and sees challenges as opportunities for growth and positive development of self, others and processes
  • Demonstrated ability and commitment to excellent customer service and to developing and maintaining effective working relationships with internal and external clients
  • Demonstrated ability to maintain confidential information
  • Demonstrated proficiency in MS Office applications, including, Outlook, Word and Excel

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

This position works independently to conduct technical service, product and process development and optimization studies of pharmaceutical products such as immediate release or extended release solid oral dosage forms.  Has overall responsibility for the relaunch and  technology transfer of a product from pilot to commercial manufacturing in conformance with regulatory requirements (FDA, cGMP, DEA, etc.), and is responsible for designing, conducting and coordinating scientific studies for the physical/chemical characterization and pharmaceutical development.

Responsibilities

  •  Responsible for designing, conducting and coordinating scientific studies for physical/chemical characterization and pharmaceutical development.
  • Perform relaunch and scale up development and optimization of manufacturing process based on regulatory guidelines related to pharmaceutical development (such as ICH Q8, Q9 & Q10).
  • Collaborate with R&D formulator and technicians regarding the design and execution of pilot and commercial process parameters, creation of formulation spread sheets, master batch record writing, batch execution, and post batch evaluation and analysis.
  • Executes experiments at lab scale and commercial scale to implement the use of quality by design (QbD) principles and design of experiments (DOE) to develop robust process parameters. Design the experiments using statistical software.
  • Evaluate retrospective quality by design (QbD) assessments of currently marketed products to improve quality, efficiency and mitigate potential cGMP and quality risk.
  • Review batch records, incident investigation reports, change controls, market complains, annual product review, product development protocols and reports, drug master files, validation documents, equipment qualification reports, technology transfer dossiers, stability data, raw material data trend, CAPAs, in process and finished product analytical data for understanding the process knowledge and identify the risks to the quality of the product.
  • Communicates to management an overview of products under development, and their stage of development.
  • Ensures compliance with all aspects of cGMP’s.
  • Assist Engineering staff for facilities design and equipment qualifications.
  • Assist Operations, Quality and Regulatory Affairs units as necessary.
  • Support R&D formulation development, Process Engineering, QbD, Scale up, Technical Service, Cleaning Validation, Process Validation, and Stability activities as mandated by cGMP’s policies/procedures and quality standards.
  • Review, as necessary, all pertinent NDA / ANDA documentation, cleaning procedures, batch history, and technical transfer reports prior to validation and/or scale up activities.
  • Prepare, approve & execute all necessary documentation, reports, protocols, batch records, etc. as required.
  • Perform process improvement projects and troubleshoot production processes.
  • Review SOPs and performance goals to ensure they reflect a commitment to quality and efficiency.
  • Perform other duties as assigned.

Qualifications

  • Bachelor’s Degree in a Science field, Pharmacy, Pharmaceutical Sciences, Chemical Engineering or related disciplines, with a minimum of 6+ years related experience and/or equivalent combination of education and experience in Pharmaceutical Development/Validation/ Manufacturing.
  • Good understanding of pharmaceutical unit operations such as blending, milling, compression, tablet coating and fluid bed coating process.
  • Experience with development of immediate and modified release technologies including matrix and pellet formulations is required.
  • Working knowledge of manufacturing equipment and/or minimal formulation knowledge is required.
  • Excellent oral and written communication skills required.
  • To perform this job successfully, an individual must be proficient in each essential duty and the ability to work with minimum supervision.
  • Thorough knowledge of regulatory filing requirements and the impact of guidance’s in streamlining the technical/ process operations is essential.
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Knowledge and Skills

  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical / process procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment

Computer Skills:

  • Ability to use PC based software programs (e.g. Microsoft® Word & Excel) and statistical programs (e.g. JMP®, MiniTab®, etc) is a plus.
  • Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)

Physical Demands:

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
  • While performing the duties of this job, the employee is frequently required to stand, talk and hear.
  • The employee is required to walk, climb ladders and scaffolding, sit, use hands to finger, handle, manipulate small objects, and to feel, to reach with hands and arms, to climb or balance, to stoop, kneel, crouch, or crawl, to enter confined spaces through openings, and to taste.
  • The employee must regularly lift and /or move up to 10 pounds, occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, the ability to determine visual density, and the ability to adjust focus.
  • The employee must be able to smell and to discern differences in odors.

Work Environment:

  • While performing the duties of this Job, the employee is regularly exposed to moving mechanical parts.
  • The employee is occasionally exposed to wet and/or humid conditions, odors, vibrations, low light, high light, high places (on the roof, scaffolding, or ladders), confined spaces, and outside weather conditions.
  • The noise level in the work environment is usually moderate.

Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

 

Machine Operator performs a wide variety of activities required to produce high quality pharmaceutical products.

Responsibilities

 •By following relevant SOP’s/Batch record instructions the operator will be responsible for performing and documenting the following activities:
• Serial/complete cleaning of product rooms and granulation equipment such as mills, mixers, ovens, etc.
• Operation of granulation equipment
• Weighing/compounding of Mutual Pharmaceutical Company products in accordance with current Good Manufacturing practices.
• Safety equipment such as respirators (PAPR), gloves, safety shoes are required.
• Must participate and successfully complete all training as required by the company.
• Perform other duties as assigned.

Qualifications

  • High School diploma or equivalent GED
  • 3+ year experience in Manufacturing. Pharmaceutical Industry experience preferred.
  • Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers and other employees of the organization.
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Knowledge and Skills

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to sit, use hand and fingers, to manipulate objects, tools, or controls; and reach with hands and arms. The employee is occasionally required to stand, walk, stoop, kneel, crouch, or crawl, and talk or hear.

The employee must regularly lift and/or move up to 20 pounds, frequently lift and/or move up to approximately 65 pounds. Specific vision abilities required by this job include close vision, color, peripheral, depth perception and the ability to adjust focus.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The employee is frequently required to work in a manufacturing environment. The noise level in the work environment is usually moderate.

Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

The Supervisor – Manages activities to ensure that the company’s stability program remains in compliance with FDA, ICH, and other regulatory and customer requirements. Manage the stability protocol, stability sample collection to testing on time. Manage sample inventory, update summary report and perform trend analysis. Report any deviation to customer, QC, QA, Quality and manufacturing head.

Responsibilities

  •  Manage and plan overall stability program
  • Manage annual stability schedule and plan
  • Review stability samples and documents received from QA for accuracy
  • Ensure Stability samples are put in correct storage condition chambers
  • Enter new stability lot to electronic stability system
  • Manage stability pull schedule and verify samples were pulled on time
  • Ensure Stability sample testing is completed within established period as per SOP
  • Review stability data summary report
  • Review and approve stability summary report
  • Perform trend analysis and report to management if data is out of trend
  • Provide stability summary report for annual product review and as requested by management/customer
  • Maintain stability protocols
  • Review change controls for new and revised protocol.
  • Monitor Stability chambers for temperature and humidity, reporting to excursions or deviations to management
  • Maintain Standard Operating Procedures
  • Assist Compliance Auditors in the inspections of stability for adherence to stability program
  • Must participate and successfully complete all training as required by the company
  • Other duties may be assigned by management

Qualifications

  •  Bachelor’s in science degree and 4+ years’ related supervisory experience or equivalent combination of education, training, and experience.
  • Thorough knowledge of cGMP’s, ICH and SOPs. Must possess excellent communication, time management, organizational, and interpersonal skills.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Physical Demands

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
  • While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to handle or feel; reach with hands and arms and talk or hear. The employee is occasionally required to stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds.

Work Environment

  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job environment.
  • While performing the duties of this job, the employee is frequently exposed to chemicals. The employee is occasionally exposed to risk of electrical shock and vibration. The noise level in the work environment is usually moderate.
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

 

The Associate, Regulatory Affairs supports the Regulatory Affairs team in day-to-day activities to ensure the timely compilation and submission of INDs, NDAs, ANDAs, Annual Reports, Periodic Reports, Amendments/Supplements, and Deficiency Letter Responses to the FDA.

Responsibilities

  • Review technical/regulatory/clinical documentation related to INDs, NDAs, ANDAs, or other applications, as assigned, to support original submissions, amendments, supplements, and annual reports.
  • Author and compile supplements/amendments to support department goals and meet FDA timelines.
  • Prepare electronic files for inclusion in eCTD submissions, per the applicable guidelines.
  • Evaluate proposed changes to applications versus current available guidance documents and formulate filing strategies and filing requirements.
  • Prepare and submit Annual Reports and PADERS in accordance with the established schedule and per applicable guidelines.
  • Create, revise, and maintain drug product labeling.

Qualifications

  • Bachelor’s degree in a science (preferably Biology, Chemistry, Pharmacy).
  • Minimum of 2 years of pharmaceutical industry experience.
  • Proficient in Microsoft Windows environment including, but not limited to, Microsoft Office products; Adobe Acrobat and plug-ins; document management systems;
  • Ability to learn new technology and apply to business needs.
  • Ability to read, analyze, and interpret scientific and technical Agency guidance. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the technology community.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

We are seeking senior Analytical Scientists to join our Analytical R&D team at our Philadelphia location. The candidate will be responsible for developing, trouble-shooting, and validating analytical test methods, writing and reviewing protocols and reports, training and supervising junior level analytical chemists and scientists, investigating deviations, OOS and OOT results.

Responsibilities

  •  Develop, trouble-shoot, and validate analytical test methods for raw materials and in-process and finished products
  • Write, review, and approve protocols and reports
  • Train and supervise junior level analytical chemists and scientists
  • Investigate deviations, OOS and OOT results, write investigation reports
  • Coordinate analytical activities of projects
  • Prepare and review analytical related documents for NDA and ANDA submissions
  • Evaluate new technologies for Analytical R&D and acquire any new relevant technologies that will improve the capability and efficiency of Analytical R&D
  • Keep abreast of new analytical technologies, FDA guidance, and ICH guidelines
  • Effectively communicate with cross functional teams like Formulation Development, Quality Control, Quality Assurance, Compliance and Regulatory Affairs
  • Attend SOP, Safety and scientific trainings to remain current with GMP regulations, and safety standards
  • Follow relevant Frontida SOP’s and FDAGuidance, and ICH guidelines
  • Other duties as assigned

Qualifications

  •  PhD in Chemistry or related majors with 3+ years of experience, or a MS degree with 5+ years of experience, or a BS with 8+ years of experience is preferred
  • Good understanding of chemical and physical analysis principles, experience in method development is preferred
  • Fundamental understanding of GMP, ICH and United States Food Drug Administration FDA compliance is preferred
  • Excellent written and oral communication skills and interpersonal skills
  • Strong knowledge of HPLC, GC, Spectrophotometry (UV, FT-IR, etc), and dissolution, knowledge on LC/MS is a plus
  • Thorough knowledge on FDA guidelines, ICH guidelines, and USP
  • Knowledge in setting specifications and justifying specifications
  • Working knowledge of MS Office (Word, Excel, PowerPoint, Access, and Outlook), Empower, and other instrument analysis software
  • Proven experience in method development and validation
  • Skills in protocol and report writing, handling of deviations and OOS/OOT results
  • Ability to present technical presentations to management to ensure understanding, responding to complex questions
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

This role will serve as the lead of all Quality activities at Frontida BioPharm, Inc, Aurora Site. The overall responsibility of this role is to oversee the Quality Systems and processes to ensure compliance to Good Manufacturing Practices, Frontida procedures and applicable regulations.

Responsibilities

  • Responsibilities include QA oversight and compliance of: quality systems (change control, CAPA and deviations); audit support; plant QA operations; internal product technology transfer; and facility compliance.
  • Responsible for drug product manufacturing/testing oversight and final lot disposition of pharmaceutical and nutritional products for commercial and clinical use.
  • Responsible for review and approval of site validation activities. Responsible for Quality Control site testing including raw materials, environmental monitoring, and microbiology and oversight of related investigations. Overall responsibility for cross-plant quality alignment. Responsible to act as a primary interface in conjunction with the Vice President Quality to ensure site support.
  • Sets strategy to enhance and maintain Quality including oversight of:
  • Accountable for quality oversight of quality management systems (CAPAs, Change Controls, Deviations)
  • Responsible for Quality Control related testing and sampling for site (Microbiology, Environmental Monitoring, Raw Materials) as well as quality assurance review of site validation activities
  • Development and refinement of quality systems and procedures
  • Provide QA support for electronic system integration (i.e. Master Control, TW, etc.)
  • Assuring appropriate GMP and QA systems training of site personnel
  • Execution of product disposition
  • Strategic oversight and leadership to meet functional and site goals and objectives
  • Responsibility for adhering to cGMP, regulations, and performance and budget management
  • Lead and coach direct team and drive a high performance organizational culture and demonstration of Frontida values
  • Responsible for timely updates of site achievements and challenges to management with a focus on quality compliance, operations performance, staff performance and productivity, staff development, continues improvements, key projects support and identification and resolving obstacles to maintain a highly effective and productive functional group
  • Interact regularly with customers to meet the needs and communicate activities and issues to line Management on a regular and timely manner
  • Champion plant metrics to ensure targets are achieved, met and countermeasures in place when applicable
  • Prepare for/support/lead regulatory inspections and third party audits
  • Providing information to regulatory submissions as necessary
  • Responsible for timely hiring, training and development of qualified staff to ensure effective execution of roles and responsibilities, GMP compliance, and attainment of operational and development goals
  • Responsible for continues improvement on an ongoing basis to proactively mitigate current and future risks to maintain an effective operation to support business needs
  • Promote and exhibit Frontida values

Qualifications

  • Degree in science or technical discipline such as chemistry, microbiology, biochemistry, chemistry, engineering
  • 7-10 years of experience in the pharmaceutical and/or nutritionals industry, preferably both
  • Proven people manager and leader capable of developing people and teams with at least 5 years of management experience
  • Track record of effective Quality leadership for internal production facilities, testing, sampling, and product disposition
  • Experience in providing Quality oversight for engineering and validation projects supporting internal operations, product development and tech transfer activities, preferred
  • Experience leading, training, and/or implementing root cause analysis and effective investigation practices
  • Operations background to ensure value added and effective quality operations, preferred
  • Experience driving out inefficiencies and improving turnaround times, preferred
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)

 

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

Responsible for planning and executing multiple validation projects simultaneously. Interaction with internal customers will be inherent to this position as well as the ability to problem solve and prioritize activities to meet project deadlines. Drive the computer validation/Qualification activities including developing/executing software SDLC (Software Development Life Cycle) documents (URS, Functional Requirements, Risk Assessment, Design Specification, IQ, OQ, PQ) to completion. Provide technical expertise, interpretation and direction to management and user departments to assure compliance with regulatory requirements, company policies and standards.

Responsibilities

  • Write protocols that challenge the critical parameters related to installation, operation, and performance of regulated systems.
  • Work within and develop standards and operational procedures for regulated systems.
  • Monitor regulatory and inspection trends and advise on suitable actions.
  • Supports change control as validation technical resource and ensures timely completion of required tasks.
  • Performs all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements.
  • Provide technical expertise, interpretation and direction to management and user in regards to computer Validation, federal regulations and other quality requirements.
  • Participate in Impact assessment for companywide GxP validated systems to ensure systems remain in a validated state.
  • Effectively interact with System Owners, QA and outside vendors.
  • Participate in continuous quality systems improvement.
  • Must participate and successfully complete all training as required by the company.
  • Perform other duties as assigned.

Qualifications

  • Bachelor’s degree in Computer Science, Chemistry, Life Sciences, Engineering or related field with 4 years hands on experience in Computer system validation or equivalent combination of education and experience.
  • Specific knowledge of computer validation methodologies, software development life cycles, extensive knowledge of cGMPs, 21 CFR Part 11, regulatory requirements and ICH guidelines.
  • Knowledge of computer network and system security principles. Working validation knowledge with any of the following system/areas; automated manufacturing systems, lab systems, Empower, EDMS, LIMS, CDAS, IT infrastructure. Working knowledge of GAMP 5.
  • Excellent written and oral communication skill, good decision making skills and time management skills.
  • Strong expertise and ability to interview and accurately interpret communication requirements of team members.
  • Proficient in the use of Microsoft Office and other applications as applicable, plus the ability to learn company used applications as required.
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
  • Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. 

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

 

Provide phone, remote and desk side support for company computers (desktop/laptop), servers and peripheral devices. Responsibilities include troubleshooting hardware, operating systems, applications software and network connectivity while documenting solutions. Installs, modifies, and makes minor repairs to personal computer hardware and software systems, and provides technical assistance and training to users with a focus on customer support.

Responsibilities

  • Provide support for company computers (desktop/laptop), servers and peripheral devices via phone, email, remote connection or desk side visits. Responsibilities include troubleshooting hardware, operating systems, application software and network connectivity.
  • Fully document all issues and their resolutions using corporate support application for future reference.
  • Escalate issues to appropriate personnel when necessary.
  • Create documentation to assist users, or other support personnel, resolve recurring issues.
  • Install and configure corporate approved hardware and software.
  • Ensure that all systems (clients and servers) are kept up to date with respect to virus protection and critical system updates.
  • Prepare requisitions for departmental purchases of approved hardware and software.
  • Perform routine network administration tasks such as creating network logins, setting up e-mail accounts, creating and securing network file shares, unlocking accounts and resetting passwords.
  • Conduct research into new technologies as directed by supervisor.
  • Ability to work effectively on multiple concurrent tasks.
  • Ability to communicate effectively with users and management with a focus on customer support.
  • Must participate and successfully complete all training as required by the company.
  • Perform other duties as assigned.

Qualifications

  • Bachelor’s degree in Computer Science, Information Technology or related field, coupled with 2+ years of experience providing help desk or desk side support and/or training; or equivalent combination of education and experience. Proficiency with all releases of Windows (XP and Windows 7), Microsoft Office (2003 – 2010) and remote management tools is required.
  • A+ or other Microsoft certification not required but beneficial.
  • Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

 

We are seeking an experienced scientist to join our Formulation team at our Philadelphia location. This is a laboratory-based position and the candidate will be responsible to support formulation and manufacturing process development by performing formulation development activities for both ANDA and NDA projects.

Responsibilities

  •  Design and develop formulations and processes for new drug products with a focus on oral solids and suspensions for clinical trials, ANDA and NDA projects
  • Utilize experimental design to rapidly optimize formulation composition and in-process specifications
  • Evaluate product testing results, provide next steps for continued development until finalize product formulation and processes
  • Present product development progress to upper management and project teams
  • Write CGMP manufacturing batch record, stability study protocol, in-process and finished product specifications and product development reports
  • Manufacture development, optimization and scale-up batches and submission batches
  • Troubleshoot formulation issues that occur during RD development, scale-ups and/or in production
  • Effectively communicate with cross functional teams like Analytical Development, Quality, PK, Regulatory Affairs and Legal teams
  • Attend SOP, Safety and scientific trainings to remain current with CGMP regulations, safety standards, and development technologies
  • Follow relevant Frontida SOP’s and FDA/ICH guidance
  • Other duties as assigned

Qualifications

  •  Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Chemistry or Chemical Engineering with 0-2 years of experience or a Master’s degree with 3 years’ experience is preferred. Experience with generic drug development is desirable
  • Good understanding of pharmaceutical formulation development principles, QbD, CMC regulation and strong organization skills
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

The Account Executive is responsible for proactively identifying and evaluating business opportunities that will effectively support the company’s revenue and profit goals.  The position requires knowledge of the brand and generic pharmaceutical marketplace and a successful track record in business development or sales.  The successful candidate must have demonstrated success in identifying market trends and ideas for growing revenue. The successful candidate will join an experienced and sophisticated business development team who compete aggressively in the market while maintaining a collaborative internal culture.  This role is best suited to those who thrive on using their existing relationships to develop creative solutions to build a sustainable revenue stream and are able to propose market segments that will be complementary to the current base business.  The position may require travel at least 30% of the time.

Responsibilities

  • Primarily responsible for driving sales growth with regional and national accounts for new product development, clinical and commercial supply
  • Financial accountability for the achievement of new products revenue, deals signed and delivering pipeline & sales funnel targets.
  • Identifying new clients, initiate contact and close opportunities
  • Prepare, present, negotiate technical pricing proposal for product development, clinical and commercial supply, in coordination with Senior Management, R&D, Contract Management, Legal
  • Conduct technical feasibility of potential new business project, and follow up with missing pertinent data for quotation.
  • Must be prepared to present quotation analysis to all levels of the organization
  • Manage the day-to-day requirements of the business relationship including pricing, contracts, forecasting, periodic business review, and additional items as necessary
  • Participate in internal process teams, conferences, trade shows, marketing campaigns, and professional associations as required.
  • Exceptional client service and account management by managing the day-to-day client activities across a variety of work streams and accounts
  • Represent the company in a professional manner at industry meetings while promoting the brand and generic business. This will include presenting product features and benefits to a targeted trade class of customers

Qualifications

  • Bachelor’s degree coupled with 5+ years of Sales Management experience in the generic or branded pharmaceutical marketplace. MBA Degree is preferred.
  • Established relationships with R&D and Commercial phase Rx pharmaceutical companies
  • Must have past experience developing and executing against customer strategies
  • Must be able to work autonomously and demonstrate superior leadership disposition (poise, business acumen, results orientation and good judgment.
  • Blend of sales and marketing background preferred
  • Strong computer skills, including Microsoft Word, Excel, and PowerPoint.
  • Ability to work effectively in an entrepreneurial environment
  • Balanced work style allowing for equal success whether working independently or collaborating with the team
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

The ideal candidate will be able to support branding initiatives and execution. This position will require collaboration with the Business Development team to identify, evaluate and finalize partnerships and agreements. This position will be responsible for supporting short and long-term marketing strategies and programs, such as creating marketing materials, e-newsletters, managing the company website and coordinating industry trade shows. In addition, this position will have the responsibility of supporting the Business Development team with lead generation, client contact, and proposal preparation.

Responsibilities

    • Lead execution of marketing strategies and programs to achieve corporate and departmental objectives
    • Manage Project timelines, analyze competitors, and build marketing campaigns
    • Prepare and present strategies, programs and budgets to senior management
    • Create Marketing materials, including website content, PowerPoint presentations, brochures and whitepapers
    • Coordinate industry events and trade shows such as (e.g.- DCAT, CPhI, AAPS, Contract Pharma)
    • Support Business Development team to drive new sales by leading lead generation and tracking initiatives
    • Ensure timely execution and finalization of proposals by preparing proposals and resolving internal and external barriers to deal execution
  • Develop internal relationships with all departments to generate content for internal and external newsletters
  • Work with marketing agency to increase website traffic through SEO and PPC efforts
  • Implementation of Pipedrive CRM System

 

  • Evaluate demographics, prices, distribution channels, and marketing outlets.

Qualifications

  • Bachelor’s Degree or equivalent
  • 3+ years of experience in the pharmaceutical marketing Industry
  • Strong organization and time management skills
  • High level of accuracy and attention to detail
  • Strong analytical and critical thinking
  • Strong interpersonal skills including communication, collaboration and negotiation capabilities
  • Excellent oral and written communication skills required
  • Ability to work with minimum supervision
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical / process procedures, or governmental regulations.
  • Ability to write reports, business correspondence, and procedure manuals
  • Analyze Data to draw both Qualitative and Quantitative Conclusions
  • Convert Findings into Written Reports
  • Ability to effectively present information and respond to questions from groups of managers

Knowledge and Skills

  • Proficiency in Microsoft® Office Suite: Word, Excel, PowerPoint.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

The Supervisor – Manages activities to ensure that the company’s labeling process remains in compliance with FDA, other regulatory and customer requirements. Label Control will manage the receiving, inspection, releasing, storage, inventory, and issuance of labeling in accordance with Current Good Manufacturing Practices (GMPs).

Responsibilities

  • Oversee the Label Control function and staff to ensure the labeling requirements for Packaging are met in a timely and efficient manner
  • Manage, plan, release and issue orders for the Labeling Administrators
  • Review labeling release documents for accuracy
  • QA release labeling utilizing the electronic inventory management system.
  • Review change controls for new and revised Labeling.
  • Maintain Standard Operating Procedures
  • Approve Labeling Master Files
  • Plan labeling shipments to affiliates
  • Order labeling from suppliers (blank labels) to maintain inventory levels for use in production
  • Prepare Labeling Investigation Reports
  • Provide labeling to the Packaging Department and meet packaging scheduling requirements.
  • Maintain databases for label printing equipment
  • Approve labeling master files; acquire applicable signatures.
  • Maintain Labeling Master Files (i.e., retire labeling master files when no longer approved for use).
  • Maintain daily employee attendance and time keeping records utilizing timekeeping system.
  • Prepare labeling investigation reports utilizing the electronic system.
  • Manage Label Control personnel to ensure all tasks are completed accurately, timely and in compliance with procedures and GMPs.
  • Develop staff to meet their personal objectives and the business needs of the company.
  • Assists Compliance Auditors in the inspections of Labeling Suppliers for adherence to GMP production of printed materials.
  • Evaluates equipment and processes to support GMP compliance within the department.
  • Must participate and successfully complete all training as required by the company.
  • Other duties may be assigned.

Qualifications

Bachelor’s degree and 4+ years related supervisory experience or equivalent combination of education, training, and experience.

Knowledge and Skills

Thorough knowledge of cGMP’s and SOPs.  Must possess excellent communication, time management, organizational, and interpersonal skills. Proficient in Microsoft Office applications (Word, Excel, Outlook) and business related application packages highly desired, plus the ability to learn company used applications.

 The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to handle or feel; reach with hands and arms and talk or hear. The employee is occasionally required to stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job manufacturing environment.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to risk of electrical shock and vibration. The noise level in the work environment is usually moderate.

 To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

 

The Manager, Regulatory Operations is responsible for the identification, qualification, and implementation of eCTD publishing tool/software, ESG submission, and spl creation. Once implemented, the Manager will be responsible for the management, preparation, quality assurance, and filing of regulatory submission to health authorities in accordance with Agency requirements and company standards.

Responsibilities

  • Identifying, qualifying, and implementing eCTD publishing tools/software for FDA submissions, implementing ESG for submissions to FDA, and spl software for Drug Listing and submission to DailyMed.
  • Planning and building electronic submissions to Regulatory Agencies, in compliance with Health Authority requirements.
  • Perform quality assurance of submissions for completeness and correctness in formatting and navigation.
  • Work with authors (both internal and 3rd party) to provide regulatory operational advice on document preparation and formatting.
  • Maintain in house repository for archiving regulatory submissions and Health Authority correspondence.
  • Responsible for Documents and Records Management.
  • Employs advanced troubleshooting techniques to efficiently address publishing tool issues.

Qualifications

  • Bachelor’s degree or equivalent in life sciences or technology-related discipline.
  • Minimum of 5 years of pharmaceutical industry experience.
  • Completed lifecycle regulatory submission publishing and document management experience required. Knowledge in eCTD (IND, NDA, ANDAs) required.
  • Proficient in Microsoft Windows environment including, but not limited to, Microsoft Office products; Adobe Acrobat and plug-ins; document management systems; publishing product lines.
  • Ability to learn new technology and apply to business needs.
  • Ability to lead and manage a growing Regulatory Operations team.
  • Ability to read, analyze, and interpret technical Agency guidance. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the technology community.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.