Opportunity to work for biopharma company focused on developing rare disease treatments.
Job Detail
Job Description
Responsibilities:
- 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
- ShareAustin:
Related Jobs
Our client is a provider-led professionally managed organization where clinical decisions are made by those who understand patient care best. They offer work-life balance and growth opportunities while doing impactful work.