Manager, Quality

Manager, Quality
MON-02792

Amylin Pharmaceuticals, founded in 1987, is a growing biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Our Research and Development team has significant experience in metabolic diseases and is focused on investigating the biological actions and utilities of bioactive peptides and other compounds as potential drug candidates. Amylin has amassed significant research and clinical expertise in metabolic medicine, including the areas of diabetes and obesity, and we’re always looking for more talented and energetic professionals with not only the requisite knowledge & experience, but also the desire and passion to help us sustain our momentum and competitive edge.

Currently, we have a great opportunity for a highly motivated, hands-on professional to negotiate and maintain Quality Agreements with selected CSPs and to ensure the requirements of the Quality Agreement are fulfilled.

Specifically, you will:

• Build strong relationships with internal Amylin operations units, external CSPs, and alliance partners
• Participate in due diligence visits to assess CSP’s Quality Systems for processing of clinical and commercial products
• Ensure that processing of clinical and commercial supplies (small molecule and proteins) products at CSPs is conducted in accordance with cGMP
• Follow up on any corrective actions identified as a result of Amylin or Alliance audits
• Write facility/process GMP commissioning plans
• Review and approve master batch records for compliance to clinical trial protocols, regulatory filings, pertinent product requirements (e.g. storage/handling, sampling etc.), and cGMP compliance
• Perform person-in-the-plant activities as required during GMP manufacturing
• Review, assess, and resolve any deviations and investigations of batch records
• Participate in the design, implementation and maintenance of quality systems for small molecules and proteins for execution

This position requires:

• A BA/BS in a related field
• 5-8 years of relevant pharmaceutical experience with small molecules and protein experience in the area of API manufacture, E. coli fermentation, and protein purification
• Demonstrated working knowledge of Quality Assurance and Manufacturing principles
• Working knowledge of worldwide cGMP regulations and ICH Q7
• Excellent interpersonal, negotiation, and written/verbal communication skills.

By “Challenging Science,� Amylin challenges conventional thinking to create innovative approaches to the discovery, development and commercialization of novel therapies for metabolic diseases. Amylin’s approach and dedication are rooted in the belief that we will be “Changing Lives� for millions of people. At Amylin, you’ll have the chance to truly make a difference in people’s lives. We also recognize top talent when we see it, and we reward it, generously, through our competitive compensation & benefits program. Amylin is proud to be an equal opportunity employer.



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AMYLIN

Challenging Science. Changing Lives.