Vector Production Director - GMP Scale-Up Leader

Sangamo BioSciences, Inc.; Richmond (CA); Vor Ort; USD 180.000 - 260.000; Vollzeit

Benefits dieser Stelle

Bonus and stock options

Medical, dental and vision care

Paid vacation and holidays

401(k) and Employee Stock Purchase

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Upstream cell culture

Downstream processing

Fill finish

GMP production

CMO management

Biologics manufacturing

Ausbildung

MS/PhD in Bioprocessing

Tools

Process validation

QA/QC systems

Jobbeschreibung

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.