Review and approval of cGMP analytical data for release and stability testing from bioassay test methods including, but not limited to, mRNA expression, functional potency and ELISA testing platforms.
Perform data integrity review (i.e. data verification) in support of validation, qualification, and analytical method trending reports, as needed
Support execution of routine Bioassay laboratory operations including, but not limited to:
Review of logbooks (reagent preparation, equipment, critical reagent tracking),
Performance of weekly laboratory housekeeping walkthroughs
Preparation of reagents
Cell Passaging
Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed.
Author analytical method performance trend reports, as needed.
Qualifications:
BS in Cell Biology, Molecular Biology, Biochemistry or a related discipline with 5+ years industry experience
Experience in mammalian cell culture and biological methods in one or more of the following areas: immunoassays, cell-based assays, and quantitative PCR methods
Experience in a GMP/GLP environment is a must.
Experience with statistical analysis software (SoftMax, JMP) preferred
Ability and desire to work in a fast-paced environment
Strong collaboration, team-working skills, and communication skills
Independently motivated and detail-oriented with good problem-solving ability
Strong communication, interpersonal and organizational skills