Director of GMP-Biologics and Cell Culturing
Natick, MA • Full Time
HebeCell is searching for a GMP Facilities Leader to be a member of our Manufacturing Operations team. The person will be responsible for GMP Facilities operations for our preclinical and phase I cGMP manufacturing facility. The person will recruit, manage and develop the GMP Facilities team to support daily operations of the cGMP manufacturing facility.
The ideal candidate is creative, team oriented and has hands on experience in all aspects of Facilities operations related to GMP utilities of a GMP manufacturing facility. The candidate will have relevant comparable background in Biologics or Cell and Gene Therapy Manufacturing . The Director will be responsible for leading the day-to-day Quality operations of cell therapy manufacturing. The role will also be a key contributor to the implementation and execution of Hebecell’s quality systems including oversight of facility and equipment validation activities, responsible for the implementation of policies, practices, procedures, standards, and systems necessary to ensure the compliance of site operations to global GMP regulations. Experience in start-up and operation of GMP clean utilities and manufacturing facilities will be a plus. The Director reports to the CSO.
- Lead the Quality team supporting Analytical activities including method qualification/validation, method transfer, establishing specifications and justification for specifications and stability protocols (clinical and commercial), data and reports. Also including laboratory release testing review.
- Oversight of Aseptic processing, environmental monitoring program, technical transfers between development/GMP and site/site oversight including operator qualification and media run program including review of analytical method qualifications, transfer protocols and lab investigations
- Interacts with the QC and QA lead to support product Risk Assessments, supporting the identification of Quality risks and appropriate mitigation plans to achieve compliant solutions.
- Oversight of equipment/facility/utility validation and requalification program and validation master plan.
- Partner with CMC, Clinical, Regulatory, QA and Nonclinical development functions to ensure GMP, GLP and GCP compliance at HebeCell
- Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into phase appropriate control strategies
Education level and/or relevant experience required: Master’s degree and 8+ years of relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 10+ years of relevant work experience, and relevant comparable background in Biologics or Cell and Gene Therapy Manufacturing Knowledge and skills (general and technical) preferred.
To apply, please submit your cover letter/ resume to: email@example.com