Allergan Principal Scientist, Pharmaceutical Sciences in Irvine, California
Principal Scientist, Pharmaceutical Sciences
Irvine, California, United States at http://agn.referrals.selectminds.com/jobs/815/other-jobs-matching/location-only
Oct 10, 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.
Our success 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.
The Principal Scientist, Pharmaceutical Sciences plans, directs, and executes oral product formulation and process development activities in support of development of new products intended for clinical trials and commercialization with focus on solid oral dosage forms including immediate and modified/controlled release systems. He/she 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.
Main Areas of Responsibilities
Provide scientific and technical leadership for development of solid oral dosage forms including immediate and modified/controlled release systems. Applies the principles of quality by design (QbD) and statistical process design/analysis to formulation and manufacturing process development.
Demonstrate scientific excellence in solid oral dosage form formulation and process development through scientific reports, published articles in peer-reviewed journals, society participation, regulatory filings, and/ or patents.
Experience working with CROs/CMOs that specialize in oral product development as well as managing outsourced development projects with key consideration to worldwide regulatory expectations.
Represent department at CMC/Project Team meetings and work closely with other Pharmaceutical Sciences departments, Manufacturing sites, CROs/CMOs, Process Chemistry, Toxicology, Regulatory Affairs, Quality, Clinical Development and Marketing to meet project timelines and objectives.
Apply current CMC regulatory requirements and guidance to support global registration of new products.
Exhibit leadership skills that result in good performance and career development of junior staff. Possess excellent communication (oral and written) and interpersonal skills.
The following listed requirements need to be met at a minimum level to be considered for the job:
In-depth understanding of pharmaceutical development of solid oral dosage forms by various technologies including high shear wet granulation, fluid bed granulation, fluid bed drug layering, roller compaction, spray drying, tableting, powder/liquid encapsulation and film coating.
Thorough understanding of pharmaceutical formulation principles, manufacturing process development and tech transfer, global CMC regulatory requirements
Experience working with poorly soluble APIs (e.g. BCS Class II, IV)
Working experience with applying Quality by Design (QbD) concepts and statistical process design and analysis (JMP statistical software) for formulation and process development.
Strong organizational skills to develop formulations intended for clinical trials and commercialization.
Proven track record in developing and manufacturing oral formulations as evident with approved products, patent applications, etc.
Experience in dealing with CROs and CMOs that specialize in oral product development and manufacture.
The below skills are attributes that may not be mandatory, but are definitely desired in the ideal candidate.
Experience in developing other novel manufacturing technologies is desirable
Knowledge of fundamental applications of statistics
- Ph.D, preferably in pharmaceutical sciences or chemical engineering with 4+ years of applicable experience or M.S with 6+ years of relevant experience.