Summary:
A prominent biotherapeutics and drug development company focused on developing innovative therapies for patients with debilitating diseases is looking for a Sr. QC Associate to work within the QA/QC team. This role will work with manufacturing and technical operations by executing QC analytical assays for product release with emphasis in cell-based bioassays (e.g. Cytotoxicity assays). The Sr. QC Associate will be expected to support technical transfer of assays from development into QC, participate in all assay validations, and perform routine GMP testing.
Responsibilities:
- Perform routine testing on clinical and commercial final product lot.
- Act as SME for analytical methods, troubleshooting, investigations, technical reports and protocol writing/revision.
- Support qualification of a GMP compliant QC bioanalytical laboratory.
- Participate in validation and technical transfer of analytical methods.
- Support drafting of SOPs, test methods, technical reports, and validation protocols.
- Execute method validation protocols and write validation reports.
- Support QC- Analytical management with internal and external inspections/audits.
- Support nonconformance investigations, root cause analysis and implement solutions.
Requirements:
- 3 - 5 years of experience with a Bachelor's in Biochemistry, Molecular and Cellular Biology, Immunology, or Biology
- Experience in cell-based bioassay and cell culture is required.
- Quality control experience in the pharmaceutical industry supporting cGMP desired.
- Experience in cGMP cell therapy manufacturing and/or testing facility is desired.
- Experience in LIMS desired.
This is an onsite 6+ month contract with possible extensions, and full benefits provided by EPM Scientific.
