Director, Vector Production

The Director, Vector Production will oversee activities related to the Process Development and in-house non-GMP/cGMP production of recombinant Adeno-Associated Viral Vectors (rAAV), and cGMP vector production at contract manufacturing organizations (CMOs).

ESSENTIAL FUNCTIONS:

• Manage the Process Development, GMP production, testing and fill finish of rAAV products at CMO's
• Manage internal activities related to the scale-up and production of rAAVs in house for use in R&D and pending facility decisions
• Lead in-house team producing rAAV
• Co-ordinate production activities with research, non-clinical development, QA, QC and clinical development
• Ensure the ongoing security of the supply chain for raw materials and intermediates to ensure the uninterrupted performance of rAAV operations
• Co-ordinate the transfer, qualification and implementation of process improvements and scale-up
• Lead the reporting, investigation and resolution of deviations encountered during GMP production activities
• Participate in the design, construction and commissioning of company manufacturing facilities
• Other activities as may be assigned

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

The ideal candidate for this position will have in-depth experience of the large-scale cGMP production of rAAV, including upstream cell culture, downstream processing, and fill finish operations.

Candidate must possess:

• MS or Ph.D in bioprocessing, chemical engineering, vector biology, or biological sciences
• Minimum of 10 years experience in the biotechnology or pharma industry with a primary focus on upstream cell culture process development and manufacturing operations for biologics
• Proven track record of managing in-house and CMO GMP production operations
• In-depth experience with:
• Mammalian cell, insect cell and microbial cell culture systems at both pilot-scale and at large-scale
• Different bioreactor production systems and scales, including disposable-based culture systems
• CIP, SIP, WFI
• In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements
• Knowledge of Quality Systems and QBD as they relate to GMP production operations and process optimization

OTHER REQUIREMENTS:

• Experience of facility, and production equipment design and validation, including IQ, OQ & PQ a plus
• Excellent written and oral communication skills
• Ability to operate in a fast-paced, multi-disciplinary industrial environment

The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including bonus and stock option plans. Sangamo offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; access to a voluntary 401(k) and Employee Stock Purchase Plan. Sangamo is an equal opportunity employer.