Associate Director, Quality Control Viral Vector - Alameda, United States - GeneFab

Description

The Associate Director, Quality Control (Viral Vector) is responsible for managing the Quality Control Viral Vector team and testing operations to support GMP Cell and Gene Therapy Manufacturing. This includes release testing, in-process testing, stability testing, and other general Quality Control tasks such as tech transfer and qualification of new assays.

• Provide operational and technical leadership to the QC Vector team through management, planning, and allocation of resources
• Optimize QC lab procedures for material and sample management, routine testing, and general lab practices to increase accuracy of testing and turnaround time
• Ensure all tests are performed per the clients' expectations; interact with them to provide test results and recommendations
• Lead Change Control, Deviation, OOS, and investigation procedures
• Maintain Laboratory equipment and work areas in good working condition
• Collaborate with the Analytical Science and Technology team to transfer biological and molecular assays between internal laboratories and clients; monitor and troubleshoot process and method performance
• Develop, author, review, and/or approve Standard Operating Procedures, specifications, test methods, protocols, reports, regulatory filings, and other controlled documents as needed
• Implement and adhere to internal and external (ICH, GMP) requirements for department functions, including training, investigations, validation, and QC testing
• Manage the QC Vector staff relating to performance management; coach and mentor staff to facilitate their personal and professional growth
• Prepare and respond to internal and external audits
• May perform other duties as assigned

• BS degree in Life Sciences or related field with 8-12 years of cGMP lab experience and at least 4+ years of management experience
• GMP operation and CDMO experience is required
• Experience performing analytical method qualification and method validations is required
• Experience with QC techniques and technology of Cell and Gene Therapy products including: flow cytometry, cell-based assays (i.e., Potency);dPCR/qPCR; HPLC; CE-SDS or SDS-PAGE
• In-depth knowledge and direct experience authoring Laboratory Investigations
• Demonstrated leadership with strong communication skills (both verbal and technical) and committed to establishing a QC culture to support collaboration and advocating for continuous improvement
• In-depth knowledge of QC principles, concepts, industry practices, and standards
• Experience utilizing LIMS in a GxP lab
• Keen understanding of international quality control systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives
• Self-motivated and passionate about advancing the field of cell and gene therapies

• The base salary range for this role is $133, $163,228.00; starting pay is determined by multiple job-related factors including a candidate's skills, education and experience level, benchmark, and internal parity.
• We offer an excellent benefits program including a selection of Medical, Dental and Vision plans, FSA, HSA, Company paid holidays, employee assistance program, commuter benefits, wellbeing resources, perks and more
• Significant growth opportunity as the company expands.

About GeneFab

GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.

We are committed to an inclusive and diverse GeneFab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.