Senior Director of Quality Control

Title: Senior Director of Quality Control

Reporting to: VP Quality

Location: Alachua, Florida, USA (On-site role)

The Alachua manufacturing site is part of Ascend Advanced Therapeutics, a gene therapy CDMO.  Ascend is a specialist AAV development partner working to support the next-generation of life-science innovators in bringing gene therapy products to patients.  Come join our team and let’s aim higher and develop the next wave of accessible life-saving therapies together.

The Senior Director QC leads a high-functioning QC group comprising of 10-12 individuals and 3-4 direct reports. The ideal candidate should be highly skilled in managing external manufacturing and testing sites both in the USA and across the world while ensuring inhouse testing laboratories are performing optimally. The successful candidate will foster a collaborative environment and play a key role in developing and executing the strategy for managing high throughput clinical and future commercial QC testing programs to ensure a continuous, global supply of Ascend’s client’s AAV gene therapies The candidate will excel in a team-based environment, working closely with the pre-clinical, manufacturing, quality assurance and regulatory departments at Ascend as well as acting as the liaison between internal manufacturing, internal QC laboratories and testing partners to ensure the accurate and timely completion of QC testing activities in support of scheduled product lot release activities.

Requirements

• Managing inhouse QC testing laboratories to ensure timely method transfer, qualification, testing & release.
• Managing and providing oversight of external testing sites (CTLs, CDMOs) both in the USA and across the world.
• Mentor individual team members and ensure positive motivation and success of the team.
• Technical lead for GMP QC data management and lot release activities.
• Ensures compliance with GLP and cGMP guidelines both internally at Ascend and at Contract testing labs.
• Author IND, BLA, NDA, IMPD sections pertaining to drug product release and stability. In addition, review and approve CTL assay development and validation reports, relevant sections of clinical documents pertaining to AAV analytical testing and documentation for submission to regulatory agencies.
• Engage in various regulatory discussions both internally and with regulatory agencies such as FDA, EMEA and MHRA.
• Establish and manage external collaborations to accomplish key QC objectives at Ascend.
• Function as an internal expert in molecular Biology test methods used for release and characterization of Gene Therapy products intended for human use.
• Oversee all Release and Stability analytical testing to ensure testing is timely and performed in compliance with cGMP, ensure product is released in a timely fashion.
• Perform QC review of in process and release data and Certificate of Analysis per internal timelines, to support lot disposition.
• Responsible for Quality System records associated with analytical testing (change control, lab investigations, OOS, deviations, and CAPAs)
• Establish and maintain Ascend’s specifications and sampling plans for in-process, drug substance, drug product, and stability. Manage implementation and changes in specifications at partner sites.
• Collaborate on preparation of justification of specification.
• Select and monitor metrics to identify risks and priorities, and improvements initiatives.
• Actively support the preparation of CMC regulatory filings including methods, batch analysis, and stability sections.
• Generate relevant QC SOPs.
• Assure ongoing readiness for regulatory inspection; participate in audits and inspections, and prepare responses to correspondence and findings, as needed.
• Recruit, train, and develop a team of Quality Control professionals as needed.

Requirements:

• MS or BS in Chemistry, Biochemistry or Molecular Biology with 15+ years of experience in pharmaceutical industry with at least 10 years of experience managing cGMP contract testing laboratories. Experience testing and releasing Advanced Therapeutic Medicinal Products (ATMPs, Gene Therapies) is highly preferred.
• Extensive technical expertise with HPLC, LCMS, GC, KF, pH, Spectroscopic sequencing methods. A strong understanding of molecular biology techniques for analysis of gene therapy products: to include (but not limited to) PCR, Infectivity, Potency, and various ELISA methods.
• Prior leadership experience managing high throughput QC testing groups.
• Experience in planning, getting approval and managing budgets.
• Experience with writing procedural documents SOP, policy, validation proposals, validation re