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

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. 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. 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.

We are seeking analytical chemists to join our Analytical R&D team at our Philadelphia location. This is a laboratory-based position and the candidate will be responsible to support formulation development by performing analytical testing and assisting in analytical method development and validation activities for both ANDA and NDA projects.

Responsibilities

  • Conduct and document chemical and physical testing of finished products, raw materials, API, in-process products, stability samples to support new product formulation development for both ANDA and NDA projects
  • Participate in analytical method development
  • Conduct and document method verification, method transfer, and method validation as per approved method validation protocols, Company SOPs and ICH Guidance
  • Conduct and document in-process and finished product testing for product release and stability as per the approved test methods
  • 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 cGMP regulations, and safety standards
  • Follow relevant Frontida SOP’s and FDA/ICH guidance
  • Other duties as assigned

Qualifications

  •  MS in Chemistry or related major with 0-2 years of experience or a BS degree with 3 years’ experience is preferred. Experience with generic drug analysis is desirable
  • Good understanding of chemical and physical analysis principles, knowledge and experience in chromatography analysis, UV, IR, and dissolution is preferred
  • Fundamental understanding of GMP, ICH and FDA compliance is 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)
  • 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

 

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

Applies engineering principles to design, modify, or develop facilities, testing, machines, equipment, or processes used in the processing, testing, manufacturing, and packaging of pharmaceutical products by performing the following duties.

Responsibilities

  • Analyzes product or equipment specifications and performance requirements to determine designs that can be produced by existing manufacturing or processing facilities and methods.

 

  • Analyzes engineering proposals, process requirements, and related technical data pertaining to facilities and equipment.

 

  • Manage all aspects of capital projects, as required, from conception to completion, including budgets, documentation, scheduling, and contractors.

 

  • Author, manage, and execute all aspects of required Qualification and Computer Validation Documentation as it relates to facility, equipment and/or computer systems.

 

  • Determines feasibility of designing new plant equipment or modifying existing facilities considering costs, available space, time limitations, company planning, and other technical and economic factors.

 

  • Provides technical information concerning manufacturing or processing techniques, materials, properties, and process advantages and limitations which affect long range plant and product engineering planning.

 

  • Compiles and analyzes operational, test, and research data to establish performance standards for newly designed or modified equipment.

 

  • Studies engineering and technical publications to keep abreast of technical changes and developments in industry.

 

  • Uses computer assisted engineering and design software and equipment to perform engineering tasks.

 

  • Provides technical expertise and assistance to the Facilities & Engineering Department for troubleshooting and investigating equipment, facility, and cGMP related issues, including updating documentation, instituting procedures, and authoring/executing qualifications.

 

  • Perform other duties as assigned.

Qualifications

  • Bachelor’s degree (B. S.) in Engineering (Mechanical preferred).
  • Three plus years related experience in an industrial manufacturing environment.
  • Prior pharmaceutical industry experience is a preferred.

Knowledge and Skills

  • Good written and oral communication skills.
  • To perform this job successfully, an individual should have knowledge of Design software; Project Management software; Spreadsheet software and Word Processing software. Proficient in Auto Cad.
  • 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

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

 

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

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

 

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 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

Supervise QA Associates in monitoring manufacturing and packaging operations, in quality record review and disposition activities and in materials and product sampling. Assist QA Management with corrective measures involving SOPs’ and cGMPs’ throughout the plant.

Responsibilities

Oversee QA Associates by managing their work assignments to ensure timely support of production operations and release of materials and product.

  • Prioritize work assignments of QA Associates
  • Provide training as needed
  • Provide leadership and guidance in decision-making
  • Undertake various QA responsibilities including, but not limited to;
  • Review and approval of – master batch record, equipment qualifications, and validation protocol and reports
  • Approve retain sample review, rejects and destruction of products and material
  • Enter QA release data into inventory control data base
  • Initiate corrective measures for quality issues in QA and other departments as instructed by QA Management.
  • Provide back-up to QA Management in job scheduling, reassignments and duties
  • Alert QA Management to potential quality issues and developing trends.
  • Prepare quarterly and annual trend reports, but not limited to Temporary process change, SOP change control, Rejects and Water test results
  • Prepare Annual product review (APR), deviations, and Quality Investigation Reports.
  • Investigate Consumer product complaints
  • Prepare response for internal quality audit in QA department
  • Approve cleaning validation results
  • Revise SOP as needed
  • Assist with training of QA staff.
  • Perform special projects as requested by Quality Management.
  • Perform other duties as assigned.

Qualifications

 

  • 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 in a manufacturing environment.
  • While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts.
  • The noise level in the work environment is usually moderate.

Knowledge and Skills

  • BA/BS or High school graduate in a technical area (preferred) with a minimum 2-3 years manufacturing experience, solid dose pharmaceutical industry a plus.
  • Ability to apply mathematical concepts such as fractions, percentages, ratios, and proportions to practical situations.
  • Must possess excellent communication, time management, organizational, and inter personal skills.
  • Proficient in Microsoft Office applications (Word, Excel, Outlook) and business related application packages highly desired, plus the ability to learn company used applications.

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

Assures all aspects of inspection processes are followed and are accurate.

Responsibilities

  • Check all areas of production for adherence to cGMP.
  • Perform in-process tests and inspections.
  • Monitor the status of materials/products.
  • Perform checks of Production/QA equipment.
  • Sample/Release raw materials and packaging components.
  • Review QA and Production logbooks.
  • Perform Room and Equipment Clearance(Manufacturing and Packaging).
  • Conduct In-process Sampling.
  • Organize Batch Record Dossiers.
  • Must participate and successfully complete all training as required by the company.
  • Perform other duties as assigned.

Qualifications

High school diploma (B.S. in science is preferred). Read, write and understand English. Adept in basic mathematical skills. Proficient in Microsoft Word, Excel, and Access.

Knowledge and Skills

  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
  • Ability to write routine reports and correspondence.
  • Ability to speak effectively before groups of customers or employees of the organization.
  • Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.
  • Ability to apply concepts of basic algebra and geometry.
  • Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
  • Ability to deal with problems involving several concrete variables in standardized situations.

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

  • Manages Mutual GMP Training Program, company-wide, and assures that company-wide GMP training is performed in compliance with Current Good Manufacturing Practices and company policies and procedures.
  • Oversee Administration of the ComplianceWire Learning Management System (LMS) including workflows for user access/ security roles, assignments/ curriculums / user groups, SOP revisions, data entry/ organization, custom fields
  • Oversee the Laboratory Qualification/ Training Module system.

Responsibilities

  • Manage company-wide GMP training program to assure that all company employees performing GMP-related tasks receive GMP training, as is necessary to comply with Current Good Manufacturing Practices and Mutual written policies and procedures.
  • Assure that qualification training is conducted in the AR&D and Quality Control laboratories, as is necessary to comply with Current Good Manufacturing Practices and Mutual written policies and procedures. Assure that training modules are properly written and implemented.
  • Oversee the ComplianceWire LMS, and the System Administrator/ Training Administrator functions, including user access/ security roles, workflows for organizing users & training items, inputting/ updating records, managing curriculums/ user groups/ assignments.
  • Communicate with the Director of Compliance, relevant to the accomplishments or impediments to the accomplishment of assigned duties and responsibilities.
  • Own responsibility for projects that may be assigned throughout the year.
  • Attend training as is necessary to remain current and in compliance with Current Good Manufacturing Practices, company policies and procedures. Periodically attend training in management skills.
  • Assure GMP trainer(s) continue to attend training, as is necessary to remain current and in compliance with Current Good Manufacturing Practices and company polices and procedures. Assure that trainer(s) periodically attend train the trainer training.
  • ComplianceWire Administration and training.
  • Perform other duties as assigned.

Qualifications

  • Manages GMP Trainers/ LMS Administrators and related staff. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, terminating and training employees; planning, assigning, and directing work; appraising performance; counseling employees; addressing complaints and resolving problems. Experience and training in the administration of ComplianceWire is preferred. Excellent knowledge and abilities in computer skills.
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Requirements 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.
  • Bachelor of Science (BS) in chemistry or biology with at least three years as a bench chemist who successfully operated laboratory equipment similar to equipment listed in the current laboratory qualification training program; working knowledge of the interpretation and application of Current Good Manufacturing Practices.

Knowledge and Skills

  • Ability to read, analyze and interpret and apply technical procedures, governmental regulations and professional journals; ability to write reports, business correspondence, and procedure manuals and to prepare training materials; ability to effectively present information and respond to questions from groups of managers, clients, customers and general public.
  • Ability to work with mathematical concepts as is necessary to perform analytical laboratory work, including, but not limited to following analytical methods and using formulas to successfully generate reliable analytical laboratory data; 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.
  • 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. The employee is occasionally required to stand, walk, use hands to fingers, handle, or feel objects, tools or controls, walk, talk and hear.
  • The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
  • 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 with disabilities to perform the essential functions.
  • While performing the assorted duties of this job, the employee works in an office & lab environment.

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 analytical chemists to join our Quality Control team at our Philadelphia location. This is a laboratory-based position and the candidate will be responsible to test finished products and raw materials.

 

Responsibilities

  • Conduct and document chemical and physical testing of finished products, raw materials, API, in-process products, stability samples within the framework of cGMP guideline.
  • Accurately compiles and reports data.
  • Obtains a fundamental understanding of cGMP’s/GLP’s.
  • Becomes proficient with a solid working knowledge of instrumentation i.e HPLC, UV, dissolution, and other analytical instruments.
  • Performs all job responsibilities in a safe, efficient manner.
  • Must participate and successfully complete all training as required by the company.
  • Perform other duties as assigned

Qualifications

 

  • Bachelor’s degree in Chemistry, Biology, bio-Chemistry or related scientific field.
  • Highly organized individual with attention-to-detail.
  • Able to work in a team environment, Cooperative and Flexible attitude.
  • Proficient in the use Microsoft Office applications (Word, Excel, Outlook).
  • The ability to learn new knowledge and skills needed for the company.
  • Previous QC experience in a pharmaceutical experience is preferred.

Knowledge and Skills

 

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 with brand companies in all phases of development, as well as generic companies
  • 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 brand and/or generic 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

Knowledge and Skills

About Frontida

Frontida BioPharm is a US-Based pharmaceutical company that offers a comprehensive suite of solutions for the development and commercialization of finished products to brand, generic and specialty pharmaceutical companies.

Frontida is the Greek word for caring, and at Frontida we invest the utmost care into all our endeavors.  The success of Frontida’s clients is at the forefront of our efforts. Not only do we strive to ensure each client reaches their business goals, we work to provide every patient with a top quality product. By creating a corporate environment of positivity and involvement we’re able to maximize the happiness of our employees, improve our local community, and deliver high quality services.

Frontida provides services in 3 main categories

Product Development- we have demonstrated expertise developing immediate and modified release oral solid dosage forms, liquids and suspensions for branded and generic products, utilizing both traditional and proprietary AdaptdoseTM and DuraGran® technologies

Contract Manufacturing – over 300,000 square feet of manufacturing space in Philadelphia and Chicago, with expertise in fluid bed processing, solvent processing, DEA controlled drug products, highly potent active ingredient manufacturing, and a fully-validated serialization packaging line.

Analytical Services– we have technical proficiency in Method development and validation for active ingredients, excipients, and finished products, GMP Testing of raw materials and finished products,  Commercial Stability & Storage services.

Frontida BioPharm Inc. Quality Manufacturing, Extraordinary Care.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA.

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 of Quality Control is responsible for the overall quality program for raw material testing or finished product testing. Manages a group of analysis to ensure timely testing of samples to support manufacturing, furnished product release and on time stability testing. Perform thorough Investigation of non-conforming results, and timely execution of CAPAs. Represent department on multidisciplinary teams. Supports QC director in managing department budget and metrics. Identify, initiate, implement and follow up continuous improvement projects. Ensure compendial updates and post submission method transfers are implemented in time. Provide leadership in the QC organization to ensure compliance, drive improvements, achieve schedule adherence. Assist quality control director as needed.

Responsibilities

  • Manage team of Chemist:

Ensure on time scheduling, testing and releasing of samples.

Conduct performance evaluations.

  • Perform comprehensive, timely and thorough investigations of deviations to identify root causes and corrective and preventive actions.
  • Work with Production Planning to align testing schedules to meet production and business needs.
  • Collect, track and report metrics to manager and improve laboratory performance.
  • Collaborate with Metrology to maintain equipment in working order.
  • Initiate, review, and approve methods of testing and procedures.
  • Approve time cards for hourly employees.
  • Prepare metric reports.
  • Improve and maintain the overall appearance and functionality of the laboratory.

Qualifications

Bachelor’s degree in Chemistry or related science field with 7+ years Quality Control experience in the pharmaceutical industry, including 3+ years supervisory experience or equivalent combination of education and experience.

Knowledge and Skills

Very familiar with the US, British, European and/or Japanese Pharmacopeias. Good knowledge of cGMP, FDA and OCHA regulations. Proficient in the use Microsoft Office applications(Word, Excel, Outlook,Access) and business related application packages. Experience with TrackWise or similar Quality Event Management software highly desired.

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.