Allergan Director, Investigational Product Manufacturing in Irvine, California
Director, Investigational Product Manufacturing
Irvine, California, United States at http://agn.referrals.selectminds.com/jobs/237/other-jobs-matching/location-only
Aug 15, 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.
TheDirector, Investigational Product Manufacturingis responsible for translating Allergan’s global master clinical study list into quantifiable demand and determining optimal manufacturing strategies to fulfill investigational supply requirements. These supplies will be used to support Allergan clinical and non-clinical studies globally. This position is also responsible for the oversight of processes used by third parties and commercial sites in support of these objectives.
Main Areas of Responsibilities
Forecast and monitor demand for investigational supplies based on frequently changing requirements within the Research and Development organization. Establish and maintain processes that ensure integrity of the supply chain.
Participate in the evaluation and selection of vendors to provide manufacturing services for investigational supplies.
Establish and maintain systems to evaluate and optimize these relationships over time. Partnerships need to be strategic and capable of delivering over the desired portion of the lifecycle of the product.
Provide Allergan “Person in Plant” role as necessary for initial manufacturing operations, troubleshooting, and deviation resolution/problem management.
Integrate new technologies from the Open Science model, either through existing channels or by adapting existing processes to enable new partners to efficiently produce within the Allergan manufacturing network.
The following listed requirements need to be met at a minimum level to be considered for the job:
A minimum of 12 years’ experience in the pharmaceutical, biopharmaceutical, or medical device industry.
Must have a strong manufacturing background, specifically with clinical trials
Must have five or more years of management experience in a product development environment
Must have thorough knowledge of both Good Manufacturing Practices and Good Clinical Practices
Thorough understanding of global regulatory requirements pertaining to clinical trial applications, technical aspects of Chemistry, Manufacturing, and Controls, as well as medical device requirements.
Must be well-versed in contract management.
- Bachelor of Science degree required, preferably in life sciences, engineering, or business.An advanced degree is desirable and may substitute for a portion of experience.