Manager, Contract Manufacturing

A global biopharmaceutical company, developing new immunotherapy products to fight cancer and other diseases, with headquarters in Irvine, California, seeks a Manager, Contract Manufacturing. 

 

The individual will be responsible for managing the manufacturing activities at contract manufacturing facilities. This includes the development, negotiation and oversight of manufacturing processes, logistics and contracts in support of GMP manufacturing of company product components and final products at contract sites. Develop and implement strategies for manufacturing of the company?s outsourced biological and synthetic components and/or drugs. Identify and manage capable contract manufacturers, and provide technical expertise for biologic and synthetic drugs.

 

MS or PhD in Chemistry, Biochemistry or related discipline with 7+ years of experience in commercial pharmaceutical manufacturing. Some experience is required in manufacturing of active pharmaceutical ingredients by biological and synthetic processes as well as of pharmaceutical products.  Comprehensive and up to date knowledge of and experience with GMP, GCP and GLP .Familiarity with FDA and EU regulations and applicable regulatory guidance documents as well as experience managing critical contract manufacturing operations strongly desired

 

The Company offers competitive compensation pay and excellent benefits including medical, dental, and vision insurance, 401(k), long and short-term disability, flexible spending accounts, seminars/professional memberships, life insurance and more!