The Associate Director, Technical Services position provides leadership for activities in Amylin’s Contract Service Provider (CSP) Life Cycle Management Process and ensures that the technology transfer from the drug development process to late phase clinical trial and commercial production is successfully completed in a high quality, cost effective manner. This position ensures that late stage drug development activities for the position’s assigned development projects are coordinated efficiently and the critical activities from development to commercialization flow as smoothly as possible. Responsibilities also include CSP due diligence activities for Phase 3 and commercial manufacturing candidates.
Supervise and lead technical transfer activities for assigned development products continuing beyond Phase 2b and driving toward commercial manufacturing by a Contract Service Provider (CSP).
Ensure the selection of the best product approach (formulation/process, packaging) based on compound characteristics, commercial/customer requirements, CSP manufacturing capabilities, and business requirements.
Ensure integration of formulation, process and drug delivery device development in conjunction with Product Development, Engineering, Manufacturing and Marketing.
Establish and manage drug product supply contracts with contractors for late stage development activities prior to regulatory approval (with input from Manufacturing and Engineering).
Facilitate supply of clinical products at the required scale, as required by the Amylin Clinical/CMC team and in conjunction with Amylin clinical supply operations personnel.
Ensure that all development studies and reports required for regulatory submissions and PAI’s are appropriate.
Ensure successful scale-up and process validation of commercial processes in partnership with the Amylin development team and Manufacturing.
B.S. in Engineering or other appropriate scientific degree required; or equivalent combination of education and experience in analytical chemistry or related field in pharmaceutical, biotechnical or related lab environment industry.
Minimum of 8 years biotechnology/pharmaceutical drug/device product experience required with increasing levels of responsibility.
Well-versed and knowledgeable in global requirements for sterile pharmaceutical products.
In-depth knowledge and experience with formulation and packaging development, alternate delivery approaches and devices.
Experience with preparation of regulatory documents for U.S., Canada and Europe.
Experience negotiating contracts with external contract manufacturers and developing the processes and procedures necessary to assure the quality of their work products.
A proven track record of delivering quality and timely results.
Strong technical background.
Ability to think strategically and conceptually with a broad understanding of the scientific, regulatory and drug development process from Research hand-off through Commercialization.
Ability to lead cross-functional project teams.
Strong analytical skills.
Adept at influencing others and building consensus to support and foster strong alliances with internal functional departments, strategic partners, scientific advisors, and regulatory agencies worldwide.
Strong communication skills, both written and verbal.
Ability to travel 20% of the time, both domestic and international.
Amylin Pharmaceuticals, Inc. - 2 years ago