Director, Manufacturing

Role Summary

Responsibilities

• Provide strategic and operational leadership of GMP Manufacturing operations with responsibility for ensuring uninterrupted production of clinical and commercial gene therapy products.
• Lead, develop, and mentor a cross-functional team of manufacturing staff and managers to deliver on production goals, operational excellence, and compliance.
• Serve as a key contributor to the manufacturing leadership team, ensuring alignment with overall company objectives and timelines.
• Act as primary manufacturing liaison with cross-functional teams including Quality, Regulatory, Analytical Development, Supply Chain, and Process Development to support tech transfers, deviations, CAPAs, and continuous improvement initiatives.
• Drive implementation of lean manufacturing principles and quality by design (QbD) strategies to enhance process robustness and reduce variability.
• Oversee execution and review of batch records, ensuring compliance with cGMPs and internal quality standards.
• Support inspection readiness activities and directly interface with regulatory agencies and partners as required.
• Contribute to manufacturing strategy development, budgeting, headcount planning, capital projects, and new technology implementation.
• Oversees execution of the Process Performance Qualification (PPQ) strategy and associated manufacturing campaign, ensuring alignment with process validation plans, quality system requirements, and regulatory expectations.
• Represent Manufacturing in CMC regulatory submissions and participate in preparation of BLA/MAA filings.
• Ensure documentation is completed to meet quality systems requirements.
• Work with Quality Assurance to achieve and maintain GMP readiness and compliance in manufacturing.
• Participate in facility safety programs.
• Hire, train, and supervise direct reports, and encourage continuing education and development.

Qualifications

• 10+ years of progressive experience in GMP biologics or gene therapy manufacturing, including 5+ years in a people management or leadership role.
• Proven experience leading cross-functional projects and tech transfers in a regulated environment.
• Direct experience with AAV vector production using adherent or suspension cell culture systems (HEK293, Sf9/Baculovirus, or other platforms).
• Prior involvement in late-phase or commercial stage manufacturing and regulatory submissions (e.g., PPQ, BLA, MAA) is a plus.

Knowledge

• Deep understanding of cGMP, FDA, and global regulatory requirements for biologics or ATMPs.
• Strong technical acumen in upstream and/or downstream processes and equipment.
• Excellent leadership and interpersonal skills with demonstrated ability to build and lead high-performing teams.
• Effective communicator with ability to influence across departments and levels.
• Strong analytical, organizational, and decision-making capabilities.
• Comfortable in a dynamic, fast-paced startup or biotech environment.

Skills

• Understanding of the principles of biologics manufacturing.
• Experience with all aspects of cell culture methods and techniques including large-scale culture.
• Experience with large-scale purification operations.
• Technical acumen with single-use technologies in biologics manufacturing.
• Understanding of the operating principles for aseptic manufacturing.
• Must have strong communication skills, both written and oral.
• Able to develop new procedures when required.
• Demonstrate skills in problem-solving and provide solutions.
• Interact effectively with staff members from multiple levels and departments.
• Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including ability to follow assignments through to completion and meet deadlines.
• Able to clearly communicate observations with management from other departments.
• Ability to lift 50lbs, assisted.
• Demonstrated strength as a supervisor including mentoring and coaching of staff, establishing priorities, and delivering on projects within budget and on time.

Education

• Bachelor‚Äôs degree in Biology, Biotechnology, Engineering, or a related discipline is required. Advanced degree (MS, MBA, or equivalent) preferred.

Additional Requirements

• Travel: <10%
• Safety: Is knowledgeable and complies with all pertinent safety policies, rules and regulations; Ensure that all team members comply with safety rules and regulations.