Employment Type: Permanent Position

Job Category: Biomanufacturing

Department: Manufacturing

Reports To (Position): Head of Manufacturing

Job Number: 3485566

Accountabilities and 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.

Essential Details:

Work Schedule

Day shift (some off-shift hours: early mornings, late evenings/nights, and weekends if necessary)

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.

Quality Responsibility

Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.

All personnel are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc.).

Scope

Works on issues of diverse scope where analysis of situation or data requires a review and evaluation of identifiable factors. Exercises judgment within defined procedures and policies in selecting methods and techniques in obtaining solutions and in determining appropriate action.  

Leadership Responsibility

Provides appropriate coaching and performance feedback to all direct reports and assures that all team members are being developed.

Minimum Requirements:

Education

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

Experience

• 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

Licenses or Certifications

N/A

Knowledge, Skills, & Attributes

• 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.
• 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.

Working Environment

A majority of the work is done in a private office, warehouse or manufacturing environment. The manufacturing environment is a cleanroom where appropriate gowning is required to be worn. Work may involve high energy hazards, such as steam, high pressure gases, flammable materials, high temperature liquids and high voltages, cryogenic operations, loud machinery and chemical hazards such as strong acids and bases.

Relocation Assistance: Yes