Allergan Principal Scientist - Analytical Development in Irvine, California
Principal Scientist - Analytical Development
Irvine, California, United States at http://agn.referrals.selectminds.com/jobs/760/other-jobs-matching/location-only
Oct 06, 2016Post 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 pharmaceuticals and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular 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.
Oursuccess is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world’s fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
Join our bold team! Learn more at www.Allergan.com at http://www.allergan.com/ .
The Principal Scientist will be an instrumental contributor and will be functionally aligned to Small Molecule Product Development. Using advanced analytical technologies, the Principal Scientist – Small Molecule Analytical Sciences will design, manage, lead, and implement analytical development activities in a cGMP environment to support all stages of drug development including drug substance and drug product development. This incumbent will develop novel methods to solve challenging analytical problems. This individual will validate and transfer analytical methods.
Principal Scientist will independently manage multiple projects and ensure timely delivery of all deliverables. S/he will establish, direct, coordinate and monitor activities at contract labs to ensure quality and timeliness of work. S/he will generate, review and approve analytical data, technical reports and analytical methods for inclusion in relevant sections of clinical trial applications and applications for marketing authorization; S/he will author relevant sections of regulatory submissions as required. S/he will evaluate, recommend, purchase and install new equipment to meet project needs. S/he will collaborate with cross-functional groups to meet drug development milestones. The Small Molecule Analytical Sciences – Principal Scientist will contribute to CMC teams and make oral presentations at project meetings. This individual will introduce cutting-edge technology to enhance the capability of the department. This incumbent will publish and give presentations at both internal and external meetings. S/he will supervise, mentor and direct the work of junior professional staff, as assigned. The successful candidate should have thorough knowledge of analytical R&D functional roles and responsibilities and basic knowledge of the drug development process. The Small Molecule Analytical Sciences – Principal Scientist will proactively contribute to drug development teams for strategies and problem solving. The successful candidate should have knowledge of relevant regulatory requirements and guidelines. Experience in cGMP is essential as is expertise in various analytical instrumentations (e.g., HPLC, GC, LC-MS, GC-MS, NMR).
A PhD (or equivalent experience) in Analytical Chemistry or Organic Chemistry and 6 years of pharmaceutical industry experience in the development and validation of analytical methods to support drug development and product registrations is required. Proven ability to apply advanced chemical analysis principles, theories, and concepts to solving complex problems associated with drug development is required. Strong ability to evaluate and interpret analytical results (including stability data) leading to recommendations regarding product quality required. Knowledge of and familiarity with cGMP and regulatory requirements (FDA and international) is required. Experience in authoring relevant CMC sections of regulatory filings is preferred. Excellent written and oral communications as well as project management skills required. This position is located in Irvine, CA and may require minimal travel.