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Form of workJob Description
Duties:
This role supports the method transfer project of the Cytotoxic T Lymphohcyte precursor cells (CTLp) Assay from *** Denver lab to CTL lab and the required comparability testing runs needed. 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. The QC Associate works within *** QC and will be expected to interact regularly with validation, other QC members, project manager, departmental management, and potentially Contract Testing Lab personnel, process/analytical development, process sciences, and translational sciences.
Reports to: QC Manager Bioanalytical
Primary Responsibilities:
Performs routine testing on final products, stability samples, and reference standards with emphasis on 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.
Participates in the execution of assay runs to meet the objective of the required comparability testing
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 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.
Assay 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 may be required.
Cell culture experience is preferred, but not required.
Travel: Up to 10%
Physical Requirements: " Subject to extended period of sitting and/or standing in a laboratory environment " Ability to lift 50 lbs. and to work in BL2 laboratory required. " Require handling radioactive isotope (51CR) following safety guidelines
EDUCATION: Bachelor's Degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other relevant Life Science with 4+ years of experience or an equivalent combination of education and experience MINIMUM DEGREE REQUIRED Bachelor's Degree (Life Science or related discipline)
MINIMUM DEGREE REQUIRED Bachelor's Degree (Life Science or related discipline)
This role supports the method transfer project of the Cytotoxic T Lymphohcyte precursor cells (CTLp) Assay from *** Denver lab to CTL lab and the required comparability testing runs needed. 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. The QC Associate works within *** QC and will be expected to interact regularly with validation, other QC members, project manager, departmental management, and potentially Contract Testing Lab personnel, process/analytical development, process sciences, and translational sciences.
Reports to: QC Manager Bioanalytical
Primary Responsibilities:
Performs routine testing on final products, stability samples, and reference standards with emphasis on 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.
Participates in the execution of assay runs to meet the objective of the required comparability testing
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 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.
Assay 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 may be required.
Cell culture experience is preferred, but not required.
Travel: Up to 10%
Physical Requirements: " Subject to extended period of sitting and/or standing in a laboratory environment " Ability to lift 50 lbs. and to work in BL2 laboratory required. " Require handling radioactive isotope (51CR) following safety guidelines
EDUCATION: Bachelor's Degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other relevant Life Science with 4+ years of experience or an equivalent combination of education and experience MINIMUM DEGREE REQUIRED Bachelor's Degree (Life Science or related discipline)
MINIMUM DEGREE REQUIRED Bachelor's Degree (Life Science or related discipline)
