Position: Cell Culture and Fermentation
AIDSVAX Project Oversight Team

Introduction:
Global Solutions for Infectious Diseases (GSID) is a non-profit global health organization engaged in the development of diagnostic and preventive tools for infectious diseases, including HIV. The AIDSVAX B/E Project involves activities related to the development and production of AIDSVAX B/E vaccine for clinical use, including internal and CMO activities. The AIDSVAX Project Oversight Team is responsible for planning, coordination, implementation and management of activities and resources associated with project goals for this and other HIV vaccine projects. Responsibilities of each team member are based on the project goals related to his/her area of expertise.

Responsibilities:

• Oversee the development, implementation, and maintenance of GSID cell culture and fermentation systems and activities, internal and external. 
• Expand staff and equip cell culture and fermentation capabilities at GSID and direct ongoing research and development efforts.
• Conduct reviews and/or audits of potential and contracted CMOs, analytical labs, and raw material vendors.
• Provide expert evaluation of CMO cell culture and fermentation systems and facilities to facilitate CMO selection.
• Participate in the generation and review of documents used in GXPs, both at GSID and CMOs and other vendors, including Master and Working Cell Banks.
• Oversee generation and characterization of Master and Working Cell Banks.
• Oversee and coordinate cell culture development and production activities at CMO(s), including acting as Person-in-Plant where required.
• Review and approve completed batch documentation for GMP production at CMOs.
• Participate in GSID investigations or oversee and review CMO investigations and resolve potential product quality issues.
• Identify and evaluate fundamental issues for Cell Culture/Fermentation functional areas through assessment of intangible variables, and interact with executive level management to influence policy making.
• Participate in corporate development of methods, techniques, and evaluation criteria for projects, programs, and people.

Required Experience:

• M.S. or higher degree in scientific discipline (biochemistry, chemistry, etc)
• 10+ years experience in biotechnology or pharmaceutical industry
• Experience evaluating, and managing CMOs, and in both bacterial and mammalian cell culture/ fermentation process development
• Hands-on experience developing, implementing, and managing cell culture/fermentation operations and a willingness to do so
• Working knowledge of cGMP requirements for production of biologics
• Previous experience with Design of Experiments and Process Validation a plus

If you are interested, please send GSID your resume.

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