Duties:
DUTIES
This role supports the execution of Cytotoxic T Lymphohcyte precursor cells (CTLp) Assay in the *** Biotherapeutics (*** Bio) Aurora, Colorado Laboratory. Emphasis is on cell-based bioassay including but not limited to cell culture maintenance, reagent prep/control, cell count and viability check, cell proliferation assays, and cytotoxicity assays. Other work includes routine lab maintenance, including but not limited to, equipment cleaning, logbook review, ordering of materials, etc. The QC Analyst works within *** QC and will be expected to interact regularly with QC members, project manager, departmental management, and potentially Contract Testing Lab (CTL) personnel, process/analytical development, process sciences, and translational sciences.
Reports to: QC Director
Primary Responsibilities:
Performs routine testing on final product by executing the targeted cell-based bioassay.
Participates in the validation and technical transfer of targeted analytical method(s) through the performance of assay runs, execution of method transfer protocols, etc.
Help to draft or revise method SOPs, FORMs, Work Instructions (WINs), stability protocols, and reference standard testing protocols, validation protocols and reports as needed.
Support nonconformance investigations, root cause analysis, CAPAs, and implement solutions, as needed.
Support day-to-day operations of cGMP laboratory (e.g. Equipment maintenance/cleaning, stocking of reagents/consumables, reagent prep, logbook review, etc.).
REQUIRED EXPERIENCE:
2 years of GMP QC Laboratory experience with actual benchtop experience conducting medium to complex GMP assays (i.e. more complex than pH, osmolality, etc.).
Robust knowledge and first-hand experience with cGMP principles and adherence to Good Documentation Practices (GDP).
Must be familiar with use of SOPs and controlled FORMs.
ssay involves use of radioactive 51Cr material. Proper PPE and safety training will be provided. Must be comfortable with use of this material.
Daily work hours are normal business hours but must be able to work longer hours on particular days of the assay schedule (occurs on occasion) and some weekend work will be required at times.
Cell culture experience is preferred, but not required.
REQUIREMENTS:
Travel: Little to no travel is expected for this position.
Physical Requirements:
Subject to extended period of sitting and/or standing in a laboratory environment.
bility to lift 50 lbs. and to work in BL2 laboratory required.
Require handling radioactive isotope (51CR) following safety guidelines.
Skills:
REQUIRED SKILLS : Bioanalytical, BL2, Cell Culture, Cytotoxicity, Good Documentation Practices (GDP), Good Manufacturing Practices (GMP),
DDITIONAL SKILLS: Laboratory, Maintenance, Method Validation, GMP, QA, Radioactive, SOPs, Validation Protocols, Analytical Assays, Bioassay, Biochemistry, Cellular, Cellular Biology, Immunology, Operations, Good Documentation Practices,
EDUCATION
Bachelor's Degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other relevant Life Science with 2+ years of professional experience in GMP QC Lab performing QC assays.
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