Position: Analytical Development
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 analytical development (AD) systems and activities, internal and external.  Expand staff and equip analytical 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 analytical capabilities 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.
• Oversee analysis of and/or provide materials for characterization of bulk drug product/final drug product and interact with CCF/PPD/QC groups in production and analysis for both in-process and release and stability analysis.
• Oversee and coordinate assay development/qualification/validation activities at CMO(s), including acting as Person-in-Plant where required.
• Review and approve completed documentation for GMP production at CMOs.
• Participate in GSID investigations or oversee, review and approve CMO investigations and resolve potential product quality issues.
• Identify and evaluate fundamental issues for AD 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:

• Ph.D degree in scientific discipline (biochemistry, chemistry, etc)
• 10+ years experience in biotechnology or pharmaceutical industry
• Experience evaluating and managing CMOs, and in analytical assay development
• Hands-on experience developing, implementing, and managing Analytical Development assays and operations and a willingness to do so
• Working knowledge of cGMP requirements for production of biologics
• Previous experience with Assay Qualification and Validation a must

If you are interested, please send GSID your resume.

TIME honors our HIV vaccine as #2 Medical Breakthrough and #8 Innovation of the Year [more]