Manger, Biochemistry

Manger, Biochemistry




A Biopharmaceutical company located in New York is seeking a Manager, Biochemist to hire, train, and develops qualified QC technical personnel. Supervise Biologics QC Biochemistry group for release and stability testing of biological products in a GMP environment. Ensure GMP compliance and efficiency in all aspects of laboratory operations. Develop and implement SOPs for various QC operational procedures. Oversee stability study and complete testing within required sample cycle time. Perform data trending analyses and the preparation of protocols and reports. Investigate OOS results and write investigation reports. Assist and coordinate technology transfer activities.





Requirements:





- B.S., M.S., or Ph.D. education and technical training in relevant areas of chemistry or biochemistry.


- Hands on experience in HPLC preferred. Experience in management of release stability testing or analytical method development in a GMP environment.


- In-depth knowledge of GMP regulations and related guidance for QC operations.


- At least 5 years of pharmaceutical industry experience.


- A minimal of 3 to 5 years pharmaceutical QC or analytical development experience. Familiar with operating procedures for QC analyses of drug substance and drug product, and those for stability studies. Experience in managing scientific or operation personnel.


- Proficient in technical writing.


- Basic knowledge in operations management. Excellent leadership, communication, and team building skills.