Great opportunity to join a large, commercially successful cell therapy and immuno-oncology company in the suburbs of NYC and Philadelphia. They are rapidly preparing for commercialization of CAR-T and other cell therapies and are actively expanding their Flow Cytometry group. This department is responsible for Flow Cytometry based testing of in-process samples, final drug product testing, stability testing, validation and requalification support, critical reagent testing and qualification, training and other critical support.
This role is responsible for all operational aspects of the QC Flow Cytometry department at the CAR-T manufacturing facility during clinical and commercial phases. The role is responsible for continuously maintaining the GMP status of the QC Laboratory, applying and ensuring staff complies to EH&S rules and safe work practices, while still hand-on testing as needed.
Responsibilities include but are not limited to;
• GMP release of in-process and drug product testing results and documentation of GMP release activities.
• Method development and validation.
• Oversight and qualification of contract testing laboratories.
• Manage an develop direct reports including management and scheduling of personnel to meet manufacturing and laboratory schedules and needs.
• Ensuring employees are properly trained and qualified to perform their assigned tasks, providing performance evaluations, and supporting career development of direct reports.
• Either directly (or through designee) be "on call" to support manufacturing issues involving sampling and/or test excursions or questions during shift operations.
• Support and/or lead audits of vendors, suppliers, and manufacturing partners.
Formal descriptions can be supplied for interested candidates.
Qualified candidates will have a BS degree or higher and 3-5+ years of life sciences experience post degree and extensive experience with flow cytometry and cell imaging, including flow related technologies related to analysis
Preference for those with advanced knowledge of cGMP, ISO, FDA, MHRA, PMDA, USP, PDA, JP, and EP regulations and guidelines as related to the manufacture of cell therapy products. May be required to gown for entry into the Aseptic Core and other supporting areas on an as-needed basis.
All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.