Associate Director, Quality Control Viral Vector

Responsibilities

• 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

Qualifications

• 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

Salary and Benefits

• The base salary range for this role is $133,550.00 - $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.