Allergan Director Chemical Development-Analytical Chemistry in Madison, New Jersey
Director Chemical Development-Analytical Chemistry
Madison, New Jersey, United States at https://agn.referrals.selectminds.com/jobs/5825/other-jobs-matching/location-only
Jun 28, 2018Post Date
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
The Director in Chemical Development Analytical group is responsible for providing analytical support to the execution of the drug substance (API) process development activities, as well as oversight of analytical activities conducted at CROs/CMOs for process development, process optimization, technology transfer, manufacturing, validation and regulatory filing activities.
Main Areas of Responsibilities
Under the supervision of the Executive Director, Chemical Development, provide analytical support to the chemical development of New Chemical Entities (small molecules), in line with the CMC-Subteam and core-team objectives, and in particular:
Ensure that all methods for starting materials, intermediates, in-process controls, and final API are adequate for the control of process-related impurities.
Liaise with cross-functional teams to ensure consistency of methods, impurity control and quality control across the Drug Substance manufacturing process and to assure the quality of final API used for non-clinical and clinical studies, registration and validation activities.
Contribute to the API regulatory strategy, including for the selection and control of regulatory starting materials and potential genotoxic impurities.
Contribute to risk analysis and mitigation plans to secure timelines, cost, and quality at all stages of project progression.
Manage and ensure proper execution of analytical development and validation work conducted by Contract Research, Development and Manufacturing Organizations (CRDMO).
Assist Procurement in preparing Requests for Proposals, and through the CDMO selection process.
Coordinate, monitor and evaluate project progression at CDMO, and timeliness and quality of deliverables.
In collaboration with the Quality Assurance department, ensure that all laboratory, pilot scale and manufacturing activities are executed in compliance with the appropriate regulation and cGMP where applicable.
Write and/or review Drug Substance regulatory documents including IND, NDA, SNDA, MAA submissions, briefing books, DMF, and other regulatory submission documents and updates.
Assist in troubleshooting analytical methods and drug substance manufacturing processes when required.
Ensure proper communication and reporting to the Chemical Development organization, CMC leads, and other functions.
Provide appropriate analytical support to Chemical Development for the scientific evaluation of APIs during in-licensing opportunities.
Minimum of 10 years’ experience in API/Intermediate/RSM development.
In-depth experience with the analytical development of small molecules; experience with polypeptides is desirable.
Hands-on experience in API method development and various analytical instrumentation (e.g. LC, GC, LC-MS, GC-MS, NMR).
Experience with outsourcing and suppliers’ management.
Practical Organic Chemistry knowledge
Excellent communication (written and oral), negotiation and external follow-up skills
Excellent knowledge of analytical development process steps, from support to Research, to process optimization, scale up, and technology transfer to commercial manufacturing.
Excellent understanding of the management of chemical and physical quality of API through process design and optimization.
Practical experience in implementing the principles of Quality-by-Design.
Excellent knowledge of how to control API chemical and physical quality on scale up.
Excellent understanding of cGMP with emphasis on analytical testing and method validation.
In-depth understanding of regulatory, compliance, and quality requirements.
- PhD in Organic Chemistry or Analytical Chemistry, or equivalent, with a minimum of 10 years of relevant pharmaceutical/biotechnology experience.
Equal Employment Opportunity Employer
Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.