Director, Contract Management
2 weeks ago
JOB SUMMARY:
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
Proven managerial skills
Outstanding organizational skills
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.
Please send your resume/CV and a cover letter that specifically addresses this job posting as email attachments to: ...@sangamo.com
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