Bioanalytical Quality Control Leader
3 days ago
Job Overview
Iovance Biotherapeutics Inc is seeking a highly skilled Bioanalytical Quality Control Leader to lead our quality control operations at the integrated Cell Therapy Center (iCTC). The successful candidate will direct all Bioanalytical quality control programs for clinical and commercial cell therapy programs.
About Iovance Biotherapeutics Inc
We are a biotechnology company pioneering novel cancer treatments. Our mission is to develop lifesaving therapies that improve patient outcomes. We believe in fostering a diverse and inclusive work environment where employees feel valued and empowered to contribute their best work.
Salary and Benefits
The estimated annual salary for this position is $**$150,000**. In addition to a competitive salary, we offer a comprehensive benefits package, including health insurance, retirement plan, and paid time off.
Key Responsibilities
- Direct the day-to-day GMP QC testing activities at the iCTC facility
- Build and lead the QC function at iCTC with hands-on work to instruct and build expertise through each phase of facility expansion and product validations
- Manage product lot release with adherence to turnaround times
- Lead and facilitate thorough GMP investigations for Laboratory investigations, out of specification test results, corrective actions, and verification of effectiveness
- Support problem solving for issues pertaining to GMP quality control, working collaboratively with technical SMEs as needed
- Support product stability programs including testing according to the agreed stability strategy, and approved Provide data in support of stability data analysis, and final reporting of stability data
Requirements and Qualifications
- Bachelor's degree in a relevant discipline (biological sciences or equivalent)
- Minimum ten (10) years of experience in the pharmaceutical industry within a Quality Control role
- Quality Control laboratory management experience, including management of direct reports
- Broad knowledge of quality control for biologics with experience in a leadership role
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