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

Responsible for the documentation, installation, calibration/verification/qualification, preventive maintenance, and repair of a wide variety of scientific instruments used at Frontida BioPharm, including but not limited to: HPLC, UPLC, GC, UV/Vis, FTIR, dissolution, particle size analyzers, etc.

Responsibilities

  • Calibrates/verifies/qualifies and performs preventative maintenance on laboratory equipment which include, but is not limited to, HPLC, UPLC, UV/Vis, GC, dissolution, FTIR, particle size analyzers, etc.
  • Inspects, evaluates, troubleshoots, and repairs laboratory equipment when problems arise.
  • Documents, reviews, and audits calibration/maintenance/repair activities of laboratory equipment.
  • Maintains calibration/maintenance schedules to keep the Calibration Program up-to-date through the Computerized Maintenance Management System (Blue Mountain Regulatory Asset Manager).
  • Completes all work in a safe and efficient manner in accordance with cGMP and GLP requirements.
  • Maintains and archives calibration/maintenance/service records.
  • Assists in the installation, operation, and performance qualification (IQ/OQ/PQ) of laboratory instruments.
  • Installs/re-installs, disassembles, cleans and makes necessary modifications to various instruments.
  • Records and reports out-of-tolerance results and any other instrument-related issues to the manager and performs corrective actions as directed.
  • Arranges for vendor service when necessary.
  • Maintains inventory and researches options on prices and availability of parts.
  • Works closely with users and external groups to help operate and develop techniques that will meet the needs of the user community.
  • Participates in writing SOPs, protocols, and instrument validation plans.
  • Aids in laboratory investigations due to instrument-related issues when needed.
  • Explores ways that maximize efficiency at lower costs.
  • Must participate and successfully complete all company training, as required.
  • Performs other duties as assigned.

Knowledge and Skills

Associate’s degree (A. A.) or equivalent from technical school; two to four years related experience and/or training; or equivalent combination of education and experience. Bachelor’s degree in Engineering or Chemistry is preferred. Calibration/Maintenance/Service certifications in lab equipment are required. Extensive Calibration/Maintenance/Repair experience on various lab instruments required. Minimum 2 – 4 years experience of HPLC, UPLC, GC, Dissolution, UV/Vis, FTIR and/or Particle Size Analyzer calibration, maintenance, and/or repair experience is preferred. Previous experience in the pharmaceutical industry highly desirable. Must have good communication and technical writing skills. Proficiency in Microsoft Word, Excel, and Outlook and the ability to learn other software applications, as required.

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 the documentation, installation, calibration/verification/qualification, preventive maintenance, and repair of a wide variety of scientific instruments used at AR&D, Frontida Biopharm, Inc., including but not limited to: HPLC, UPLC, GC, UV/Vis, FTIR, dissolution, particle size analyzers, etc.

Responsibilities

  • Calibrates/verifies/qualifies and performs preventative maintenance on laboratory equipment which include, but are not limited to, HPLC, UPLC, UV/Vis, GC, dissolution, FTIR, particle size analyzers, etc.
  • Inspects, evaluates, troubleshoots, and repairs laboratory equipment when problems arise.
  • Documents, reviews, and audits calibration/maintenance/repair activities of laboratory equipment.
  • Maintains calibration/maintenance schedules to keep the Calibration Program up-to-date.
  • Completes all work in a safe and efficient manner in accordance with cGMP and GLP requirements.
  • Maintains and archives calibration/maintenance/service records in Blue Mountain RAM.
  • Assists in the installation, operation, and performance qualification (IQ/OQ/PQ) of laboratory instruments.
  • Installs/re-installs, disassembles, cleans and makes necessary modifications to various instruments.
  • Records and reports out-of-tolerance results and any other instrument-related issues to the manager and performs corrective actions as directed.
  • Arranges for vendor service when necessary.
  • Maintains inventory and researches options on prices and availability of parts.
  • Works closely with users and external groups to help operate instrumentation and develop techniques that will meet the needs of the user community.
  • Participates in writing SOPs, protocols, and instrument validation plans.
  • Aids in laboratory investigations due to instrument-related issues when needed.
  • Explores ways that maximize efficiency at lower costs.
  • Must participate and successfully complete all company training, as required.
  • Performs other duties as assigned.

Knowledge and Skills

Bachelor’s degree in Chemistry or Associate’s degree (A. A.); one to two years related experience and/or training; or equivalent combination of education and experience. Calibration/ Maintenance/Service certifications in lab equipment are preferred. Knowledge/skill/experience in the operation of various laboratory instruments is required. 1-2 years of HPLC, UPLC, GC, Dissolution, UV/Vis, FTIR, and/or Particle Size Analyzer calibration, maintenance, and/or repair experience is preferred. Previous experience in the pharmaceutical industry highly desirable. Must have good communication and technical writing skills. Proficiency in Microsoft Word, Excel, and Outlook and the ability to learn other software applications, as required. Experience with Blue Mountain RAM is preferred.

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

Oversees, the development, implementation, compliance, reporting and monitoring of the Company’s environmental, health and safety (EHS) programs. Overall responsibility to ensure Company standards & regulatory requirements are met with respect to the safe operation of the company facilities.

 

Responsibilities

  • Ensures compliance with applicable federal, state, and local regulations as well as company policies.
  • Compiles and submits all required reports to local, state and federal authorities. Compiles and maintains accurate recordkeeping for all regulatory agencies including OSHA, EPA, DEP, DOT, etc.
  • Responsible to see that lost time and OSHA recordable safety goals are met. Oversees and maintains day-to-day safety programs at the company’s facilities.
  • Coordinates the investigation of incidents as necessary, reviews, approves incident reports.
  • Evaluates potential workplace hazards and ensures that ongoing programs/remedies are implemented.
  • Promotes the safety program and strongly influences employees and management teams throughout the organization, by developing, implementing and maintaining general company safety policies and procedures to ensure regulatory compliance and promotion of company objectives.
  • Inspects (audits) organization facilities to detect existing or potential safety and health hazards, and recommends and implements corrective or preventative measures, and follows up to ensure measures have been implemented.
  • Advise management on health and safety issues and recommend ways to improve the safety of our operations. Follows up with departmental management to ensure that recommendations are implemented as required.
  • Develops training policies, programs, and schedules, selects or develops teaching aids such as training handbooks, demonstration models, multimedia visual aids, computer tutorials, and reference works and conducts training sessions.
  • Communicate Safety & Health requirements and assist departments in implementing responsive programs, promote and encourage the safe utilization of equipment and facilities.
  • Chairs and directs the safety committee.
  • Represents the company to governmental inspectors, insurance companies, and contractors as appropriate.
  • Provides safety assessments for proposed research products. In the absence of published OEL or TWA, sets limits based on scientifically-defensible techniques and data.
  • Maintains and monitors the following and other programs as necessary: MSDS Database, fire extinguishers, hazardous and non-hazardous waste handling, respirator training, safety glasses, etc.
  • Provides and administers training for fork truck, confined space, violence in the work place, blood borne pathogen, fire extinguisher, HAZCOM, PSM, Lock-out/tag out, confined space, CPR, respirator & respirator fit test, hot work, incident/accident, DOT, IATA, HAZWOPPER, etc. This includes new employee  and contractor safety orientation and training.
  • Ensures proper safety apparel, equipment and services are provided, i.e. Safety Shoe and Glasses programs, etc.
  • Provides or arranges industrial hygiene services where appropriate.
  • Coordinates workers’ compensation program, including working with the employee, insurance carrier and medical providers regarding appointments, lost-time, restrictions, etc. also maintains safety files and records
  • Other duties may be assigned.

Qualifications

• Bachelor’s Degree in Chemical Engineering, Safety Engineering, EH&S Management or related field. Professional certification is a plus.
• Five plus years of experience, in a manufacturing environment required, Chemical or Pharmaceutical industries a plus. Previous experience with pharmaceutical solid dosage manufacturing and managing a staff in a cGMP regulated environment.
• Must have thorough and demonstrated knowledge and experience with federal, state and local Safety & Health regulations, including DOT, OSHA, etc.

Knowledge and Skills

  • Experience in development, organization and implementation of facility-wide, safety programs.
  • Demonstrated ability to recognize, evaluate, and recommend controls for workplace hazards.
  • Demonstrated ability to determine training needs, organize and/or conduct training. Excellent written and oral communication skills.
  • Computer literate and proficient with Microsoft office suite and applicable applications related to perform the Safety Coordinator function.
  • Strong communication skill.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.

 

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.

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 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

The GMP Training System Specialist is responsible for managing the administrative functions of the training system for the Philadelphia locations.  This includes managing job codes, exams, on-the-job training (OJT) documentation and increasing the use of the LMS system functionality to support the site operations and compliance.

Responsibilities

  • Supporting the conduct of effective new employee orientation sessions in a timely manner
  • Process training related tasks and documents through applicable EQMS systems in a timely manner
  • Communicate to job code owners, SOP authors and other key stakeholders when tasks are required of them such as exam writing, review and approval, job code evaluation and task initiation. Drive timely completion by stakeholders to support procedure approval timelines
  • Write or revise exams for new and revised procedures in a timely manner
  • Support authors of SOPs in writing and revising exams
  • Manage Job Code organization and structure to ensure employees are trained appropriately, job codes are organized to support the departments and OJT is reflected in the EQMS where possible
  • Generate reports of pending and overdue training including monthly metrics as requested
  • Assist departments who require On-the-Job (OJT) training to manage the structure and documentation of such training as applicable, e.g., lab modules, manufacturing OJT
  • Other assigned administrative tasks as required in keeping the company compliant with cGMP, industry standards and regulations (e.g., organizing and filing paper-based training records, managing electronic copies of training records on shared drives and in the LMS, etc.)

Qualifications

  • Bachelor degree in education or relevant field with 1-2 years in training or a bachelor degree in a life science with 2-5 years in training
  • Pharmaceutical experience is preferred
  • Strong communication skills
  • Experience in using and managing an electronic learning management system
  • Strong writing skills and record keeping ability for reports and training manuals
  • Good computer and database skills
  • Works well across all departments and 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

For a contract manufacturing organization (Frontida BioPharm, Inc. – Philadelphia, PA): perform method development, verification and validation for drug products and raw materials using various analytical procedures and dissolution techniques; perform reverse engineering for generic products; optimize procedures of analytical methods; investigate abnormal results; operate and troubleshoot GC, HPLC, UPLC, UV/Vis and FT-IR.

 

Work Location: Philadelphia, PA.

Hours: 40 per week – Monday through Friday

To apply online.

Qualifications

Requirements:

  1. Master of Science or foreign equivalent degree in Chemistry, Analytical Chemistry or a related field.
  2. 2 years experience in job offered or 2 years experience as a Research Scientist in the pharmaceutical industry.  This required experience must include 1 year experience in generic products development (suspension, injectable, tablets, capsules), small scale per cGMP procedures and manufacturing processes optimization, and 1 year experience in reverse engineering for products and analytical method development/validation using HPLC, LC-MS/MS, UPLC, GC, GC-MS, fluorescence, XRD and particle size analytical techniques, including Mastersizer and Zeta Potential.

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 Director, Compliance and Quality Systems will have the responsibility for managing and leading functions that include but are not limited to investigations, training, internal auditing, quality oversight of validation (process and computer), metrics and quality council primarily for Frontida PA and for Frontida Aurora where processes are shared across sites.

Responsibilities

Responsible for leading the compliance processes and quality systems including investigations, training, internal auditing, quality oversight of validation (process and computer), and metrics reporting. Ensure these processes are designed and executed according to cGMP, company SOPs and applicable regulations.

 

  • Collect metrics across the company for trending of quality performance, identification of trends and improvement opportunities
  • Lead the quality council management review meetings by presenting metrics, quality initiatives and driving quality improvement across the organization
  • Manage direct reports and team, drive a high performing organization, develop personnel for current and future roles within Frontida
  • Provide Quality support for electronic system integration
  • Collaborate across sites to develop common processes and procedures where applicable
  • Drive continuous improvement of quality systems to proactively mitigate current and future risks to support business needs

Knowledge and Skills

  • Bachelor’s degree in in a related discipline with 10-15 years of experience in pharmaceutical quality with broad knowledge of GMPs, solid and oral dosage forms, manufacturing and auditing, required
  • Experience leading teams to improved performance demonstrated through metrics
  • Knowledgeable of cGMPs and regulations pertaining to quality system requirements for oral dosage forms, preferred
  • Experience with quality systems, investigation writing, CAPA, preferred
  • Experienced in conducting internal audits, and preparing for and hosting agency inspections and audits, 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

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

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

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

 

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

Provides support to the Product Development and/or CMS-Manufacturing group in performing Product development, Process improvement, Scale up, and Validation activities as mandated by cGMP’s policies/procedures and Frontida’s quality standards.

Responsibilities

• Assist CMS Manufacturing Associates and/or R&D Formulation group in running projects associated with product development, product and process optimization batches, and on completion to ensure robustness of the process and formulation.
• Assist CMS Manufacturing Associates and/or R&D Formulation group in coordinating cleaning, process validation and CMS technical / process operations activities with company quality units, operation, R&D and regulatory affairs for commercial or R&D products.
• Assist CMS Manufacturing Associates and/or R&D Formulation group in executing cleaning, process validation and/or CMS technical / process operations protocols, ensure sampling and testing are completed as planned, assist in writing reports and preparing master formulary records.
• Follow protocol and batch records in manufacturing development batches and relate observations to CMS Manufacturing Associates and/or R&D Formulation group.
• Follow departmental and company SOPs and policies.
• Must participate and successfully complete all training as required by the company.
• Perform other duties as assigned.

Qualifications

  • High school diploma with 5+ years’ experience in a pharmaceutical environment or equivalent combination of education and experience.
  • Cross trained in the manufacturing unit operations such as granulation, blending, compression, coating and encapsulation is highly desired.
  • Knowledge of manufacturing equipment such as granulators, tableting machines, coaters, and encapsulators is preferred.
  • Mechanical skills/ability is required.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • cGMP knowledge is essential.
  • Knowledge of analytical laboratory testing is a plus.
  • Proficient in the use of Microsoft Office and other applications as applicable, plus the ability to learn company used applications as required.
  • Ability to travel occasionally as required and ability to work occasional shift and weekend work as required.

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.