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.
About the role
The Associate Director, Analytical Quality Control is responsible for providing strategic and operational leadership for the analytical quality control organization supporting GMP manufacturing, product release, stability testing, and analytical method lifecycle management. The role oversees QC analytical laboratories and ensures that all testing activities comply with cGMP regulations, regulatory expectations, and company quality standards.
What you'll do
- Ensures that QC Systems and practices are developed and implemented in accordance with the requirements of GMP.
- Lead, mentor, and develop a team of quality control professionals, fostering a culture of excellence, collaboration, and continuous improvement.
- Demonstrate experience performing and managing analytical method development, phase appropriate method qualification/validation, and release and stability testing.
- Ensures that delivery of data is accurate and on time.
- Provide mentorship to direct reports and maintain clear communication on performance to direct reports.
- Proven proficiency working with quality systems including SOPs, protocols and reports, release and stability data review, OOT and OOS management, Good Documentation Practices, LIMS and cGMP data traceability, Deviations, and Change Management.
- Owner of the Quality control metrics to assess overall and individual performance to ensure continuous improvement opportunities are being assessed and applied.
- Manage QC inputs to Annual Product Quality Reviews and Quality Management Reviews.
- Oversee trending of commercial product quality (Drug Substance, Drug Product, Finished Product) and commercial QC analytical method performance.
- Manage QC deviations, CAPAs, and change controls for clinical and commercial products.
- Collaborate with Manufacturing, MSAT, AD, and Validation to ensure effective technology transfer from internal departments and external companies.
- Oversee Management team to ensure subject matter expertise is instilled to develop scientists’ motivation, education, efficiency, and performance management of individuals.
- Coordinate with Analytical Development resources to optimize test methods and execution to streamline laboratory functions, operations, and improve overall quality of such functions.
- Oversee and support method validation and verification activities, and method transfer between sites for clinical/commercial products.
- Work with the Quality Assurance Department to improve and sustain an effective and efficient quality management system.
- Responsible for GMP-compliant analytical laboratory and safe working environment.
Qualifications
- MS or BS in Analytical Chemistry, Biochemistry, Molecular Biology, Pharmaceutical Sciences, or related scientific discipline.
- 10+ years of experience in biopharmaceutical analytical testing within GMP environments.
- 5+ years of leadership experience.
- Experience supporting clinical and commercial manufacturing programs.
- Strong knowledge of regulatory requirements and standards governing bio-pharmaceutical quality control (cGMP, ICH, FDA, EMA, etc.).