Director, Vector Production

Sangamo BioSciences, Inc.; Richmond (CA); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Bonus and stock options

Medical, dental and vision care

Paid vacation and holidays

401(k) and Employee Stock Purchase

Job summary

The Director, Vector Production at Sangamo BioSciences, Inc. will oversee Process Development and in-house non-GMP/cGMP production of recombinant AAV vectors, and cGMP vector production at CMOs.

The role leads the in-house team, coordinates with research, QA/QC and clinical development, and ensures supply chain integrity for raw materials. Strong expertise in upstream/downstream processing is required.

Qualifications

• MS or PhD in bioprocessing, chemical engineering, vector biology, or biological sciences.
• Minimum of 10 years experience in biotech/pharma with focus on upstream cell culture process development and manufacturing operations.
• Proven track record managing in-house and CMO GMP production operations.
• In-depth experience with mammalian, insect, and microbial cell cultures at pilot and large scale.
• Experience with bioreactor systems and disposable culture systems.
• Familiar with CIP, SIP, WFI; knowledge of FDA/EMA/ICH GMP requirements.
• Knowledge of Quality Systems and QBD in GMP environments.

Responsibilities

• Oversee process development and GMP production, testing and fill/finish of rAAV at CMOs.
• Manage in-house scale-up and production of rAAV for R&D and facility decisions.
• Lead in-house team producing rAAV and coordinate with research, QA, QC, and clinical development.
• Ensure uninterrupted supply chain for raw materials and intermediates.
• Coordinate transfer, qualification and implementation of process improvements.
• Lead reporting, investigations and resolution of GMP deviations.
• Participate in design, construction and commissioning of manufacturing facilities.

Skills

Upstream cell culture

Downstream processing

Fill finish

GMP production

CMO management

Biologics manufacturing

Education

MS/PhD in Bioprocessing

Tools

Process validation

QA/QC systems

Job description

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.