The Sr. Scientist position will be based in Irvine, CA. Reporting to the Executive Director, Small Molecule Product Development, following are the main areas of responsibilities:
Plans, directs, and executes drug product formulation & manufacturing process development activities in support of development of new products intended for clinical trials and commercialization. Applies the principles of Quality by Design and statistical process design/analysis to formulation and process development. Conducts research in the area of formulation sciences in support of innovative product development both for new chemical entities and life-cycle management of marketed products.
Provides scientific and technical leadership on one or more areas of formulation development and dosage form design. Develops and maintains a current in-depth knowledge of global CMC regulatory submission requirements and GLP/GMP requirements. Review internal and external technical documents, writes technical memos/reports, patents, scientific articles. Presents scientific/technical seminar annually at Pharmaceutical Development Seminar series.
Represents department at CMC/project team meetings and work closely with other Pharmaceutical Sciences departments, Process Chemistry, Toxicology, Regulatory Affairs, Quality, Clinical Development and Marketing to meet project timelines and objectives.
Performs supervisory duties including reviewing progress of assignments against established project timelines, assistance on daily work direction, problem solving and advice to junior staff to enhance their work effectiveness in generating data, ensuring good record keeping of all laboratory data, adherence to lab safety and general staff development.
The following listed requirements need to be met at a minimum level to be considered for the job:
Must be able to operate as a functional area leader and utilize knowledge of pharmaceutical science, chemical engineering, literature and experience to guide decisions in complex situations. Knowledge of fundamental applications of statistics is preferred.
This position requires a Ph.D. level education preferably in pharmaceutical sciences or chemical engineering with 4+ years of applicable experience or MS with 10+ years of relevant experience.
Internal Number: 184331
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.