Associate Director / Director, QC

Position Summary: 
We are seeking a highly motivated individual to join Synthekine, Inc. as Associate Director/Director of Quality Control. The position will report to the Synthekine Sr. Vice President of Technical Operations.  Associate Director/Director of Quality Control will provide leadership of the development and implementation of all quality control related activities to support the Synthekine clinical ready products. This will include Quality control business process build out and oversight of CMO quality control procedures, technical qualification/validation, and execution of multiple methods. The ideal candidate will support phase appropriate critical quality attribute determination for Biologics and Cell manufactured products and leading the external stability programs. This role will require full collaboration with Analytical Development, Process Development, Manufacturing Operations, Quality Assurance, and Regulatory Affairs teams. 

Key Responsibilities:

• Develop and implement phase appropriate Quality Control procedures and systems for the Synthekine clinical products.
• Oversee the Quality control testing operations for in process, lot release and stability programs being conducted at the CMO sites.
• Review and approve all test methods, qualification protocols and reports, sample management forms, and QC related SOP’s from the CMO site to ensure technical content.
• Have a strong working relationship with our CMO’s and CRO’s performing GMP testing activities.
• Foster a quality and continuous improvement mindset to ensure that all QC deliverables are cGMP compliant in a phase appropriate fashion to support early, late clinical phase and commercial programs.
• Set strategy in partnership with the Technical Operations Leadership and assure appropriate management oversight of Quality Control performance.
• Lead quality professionals, including objective setting, performance management, coaching, training/mentoring, development, and recruiting.
• Proactively identify issues, concerns or any potential or significant risks to the business and ensure that appropriate preventative actions are in place.
• Recommend, monitor, and engage in corrective actions for all identified excursions for QC testing and stability program testing.
• Lead the development, articulation, implementation, and continuous improvement of the Quality Management System.
• Foster an environment of collaboration, trust, quality, risk management, innovation, and continuous improvement.

Qualifications:

• Associate Director: Bachelor of Science (B.S.) degree or equivalent in experience. Advanced degree preferred. Must possess at least ten (10) years of quality control or analytical technical experience within the pharmaceutical or biotechnology industry.
• Director: Bachelor of Science (B.S.) degree or equivalent in experience. Advanced degree preferred. Must possess at least ten (12) years of quality control or analytical technical experience within the pharmaceutical or biotechnology industry.
• Demonstrated experience with analytical techniques for testing biologics products, lentiviral vector products, and cell manufacturing products.
• Experience managing Quality control testing groups for Biologics and cell therapy projects
• Demonstrated relationships with CDMO and /or CRO vendors for product release testing.
• Demonstrated success in evaluating quality compliance issues in all phases of clinical development and with Biologics and Cell therapy programs
• Broad knowledge of and experience with regulatory requirements for clinical and commercial products
• Experience in a smaller pharma/biotech which has reached commercial stage is ideal.
• Relevant experience with quality management systems, document control systems, and LIMS.
• Previous experience in establishing GMP documentation.
• Able to respond to inquiries or complaints from regulatory agencies.
• Ability to read, analyze and interpret scientific information and reports, technical journals and legal documents.

The anticipated salary range for the position of Associate Director/Director, Quality Control based in our Menlo Park, CA office is $167,000 to $190,000 (Associate Director); $208,200 to $236,000 (Director).  The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc.  Synthekine is a multi-state employer, and this salary range may not reflect positions that work in other states. We comply with all state federal and local laws regarding pay practices.