QC Microbiology (AMLN-02268)

Amylin Pharmaceuticals is committed to improving the lives of people with diabetes and other metabolic diseases through the discovery, development, and commercialization of innovative, cost-effective medicines. Our rapid growth has created the following outstanding opportunity in Cincinnati, OH:

 

QC Microbiology

 (AMLN-02268)

 

This position manages the technical and operational aspects of the Quality Control Microbiological Laboratory, including method transfer and validation activities.

 

Responsibilities:Qualify and implement microbiological methods to support an aseptic pharmaceutical manufacturing facility, such as sterility and endotoxin and support facility commissioning and qualification activities. Develop, implement and oversee the daily operations of a Quality Control Microbiology group and ensure that the laboratory is maintained in a state of GMP compliance, that all documentation is generated in accordance with GMP and that all reported results are accurate. Review and approve recommendations and/or analytical QC data presented by subordinate(s) and conduct investigations as an area expert for appropriate discrepancies. Participate with senior and executive management in the decision making process for capital equipment expenditures and the acquisition of new technologies. Represent the department during FDA and/or regulatory inspections, and interact with regulatory agencies to present and defend QC data. Recruit, train and supervise QC analysts.

 

Requirements:Bachelor?s degree in Biology, Microbiology, Biochemistry or another relevant life science discipline. 8+ years experience in a pharmaceutical/biotechnology lab. Experience in supervising technical personnel. Sterility testing experience is a plus. Excellent project management skills including the ability to plan, prioritize and complete own work and the work of others. Excellent interpersonal skills including the ability to effectively collaborate with staff from other departments. Excellent verbal/written communication skills and the ability to invest time to complete assignments, which may include working non-standard hours such as evenings and weekends as necessary. Strong spreadsheet, word processing and database skills necessary to process and present technical data in a clear and concise manner.

 

Amylin offers competitive compensation, benefits and stock options. Amylin maintains a drug and alcohol free workplace and all offers of employment are contingent upon satisfactory completion of a pre-employment drug and alcohol test. Please apply online at: http://careers.amylin.com AA/EEO Employer.

 

Amylin

Pharmaceuticals