Manager I/II Clinical Manufacturing

Major Duties and Responsibilities (including supervising others): The successful candidate will lead GMP purification activities for the production of MedImmune vaccine based products for use in clinical trials. The candidate will also be responsible for clinical drug product filling activities within our clinical manufacturing facility. The candidate must have an in depth knowledge of GMP operations in a manufacturing facility and have expertise in purification processes and equipment. The Manager will directly lead a group for purification activities and work with other pilot plant managers and staff to successfully complete manufacturing programs. The Manager will work closely with Development, Validation, QA and QC to successfully transfer processes into the pilot plant and complete the required GMP documentation and processing. Requirements/Qualifications and Education: B.S/B.A. or MS/MA in Biology, Biochemistry, Biochemical Engineering or related scientific field. Experience: Relevant experience with a minimum of 10 years with a BS/BA or minimum of 8 years with a MS/MA is required. Direct experience in the manufacturing of biologic products and formal training in current Good Manufacturing Practices (cGMP) is required. Excellent verbal and written communication skills are strongly required as well as ability to function as a team member. Experience with supervision of associates and management of manufacturing operations is expected. Special Skills/Abilities: Expert knowledge of purification equipment and processes is required. Knowledge of aseptic filling processes and requirements is a plus. The following experience is required: in writing of GMP documents such as specifications, investigation reports, SOPs and batch records; GMP change control and validation activities in a GMP environment; technical transfer of processes into a GMP environment and working with Process Development group. The candidate is expected to have the ability to identify areas of potential risks, and assist the management team in developing and implementing plans to address them. Mechanical aptitude, troubleshooting ability, and working knowledge of process control systems for control and monitoring of processes are a plus.Job Complexity: Flexible work hours will be necessary, including occasional evening and weekend work. The job includes equipment maintenance, troubleshooting, facility and equipment cleaning. The job requires the ability to concurrently work on multiple clinical candidates, some in the GMP pilot plant and others being readied for future manufacturing. Supervision: The candidate is expected to have the ability to work and lead multiple projects with minimal supervision.CLICK HERE TO APPLY MedImmune, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law. Job Title: Manager I/II Clinical Manufacturing Location:  US-CA-Santa Clara - NON SALES Status:  Full Time, Employee Job Category:  Sales/Retail/Business Development