This role supports the Quality Control and manufacturing operations by executing QC analytical assays for in-process, product release and stability with emphasis in cell-based bioassays (e.g., viable cell count, Immunophenotyping, cytotoxicity assays). The candidate must have GMP laboratory and bioassay, cell biology or immunology experience. The selected individual will be expected to support cell culture, routine GMP testing, QC projects for clinical and commercial products in compliance with GMP regulations.
Reports to Sr Manager, Quality Control
Location Thousand Oaks, CA
- Performs routine testing for in-process, intermediates, final product, and stability of clinical and/or commercial lots.
- Act as subject matter expert for analytical methods, troubleshooting, investigations and/or technical reports
- May participate in the analytical method transfer and/or validation, as well as critical reagents qualifications
- Draft and review laboratory SOPs, test methods and technical documents.
- Train QC Associates
- Participate of internal and external inspections and audits as subject matter expert
- Support nonconformance investigations, root cause analysis and implement solutions
- Support laboratory equipment validations, as needed
- Ensure compliance with applicable company requirements and global regulations
- Bachelor of Science (B.Sc.) with 3+ years of experience or an equivalent combination of education and experience; or Master of Science (M.Sc.) with 0-3 years of experience
- Experience in cell-based bioassay and cell culture is a must.
- Quality control experience in the pharmaceutical industry supporting cGMP areas
- Experience in cGMP cell therapy manufacturing and/or testing facility is a plus.
- Role model for company core values of trust, delighting our customers, Gemba, and Genki.
Join us! FDB is advancing tomorrow's medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.
FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.
To all agencies Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.