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Senior Analyst, Quality Control Analytical
GeneFab
Alameda, USA
Full-time
Senior Level
Onsite
USD 45-55 hourly
Discovered 1 weeks ago
Free
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- Provide technical expertise (SME).
- Provide technical support to Analytical Development and QC Analytical Operations as needed.
- Develop, implement, and update all Quality Control SOPs, testing records and other documentation needed for cGMP compliance.
- Perform QC testing on in-process and final product samples to support release and stability testing.
- Lead and perform technical root-cause investigations for aberrant results and deviations relating to analytical methods.
- Lead and train junior employees to ensure testing procedures and practices comply with all applicable regulations and procedures.
- Plan, lead, and execute analytical method transfers, qualifications, and validations.
- Draft, Review, and Approve Method Transfer Protocols and Reports
- Generate and review procedures, protocols and reports.
- Proactively identify areas for continuous improvement in processes and procedures and lead these initiatives.
- Collaborate closely with Interdepartmental MSAT, ASAT, and Manufacturing groups to support, execute, and/or provide oversight in the execution of method optimization, characterization, troubleshooting, transfer, and qualification
- Perform additional duties as assigned
- B.S. degree in biology or related field with experience in cell therapy, immunology, cancer biology, or a closely related field.
- Minimum of 5+ years of GMP/QC Laboratory experience.
- Demonstrated ability to collaborate and work in cross-functional teams.
- Strong organizational skills and attention to detail
- Strong time management skills with a proven ability to meet deadlines
- Strong analytical and problem-solving skills
- Experience with relevant technologies such as: multicolor flow cytometry, cell culture (e.g., aseptic techniques, cell line expansion), multiplexed immunoassay, qPCR, and dPCR methods, Luminex, and ELISA.
- Experience in GMP.
- Experience with contract laboratories and or CDMO is a plus
- Knowledge related to laboratory information management systems (LIMS) and electronic lab notebook record keeping (ELN) is a plus
- Proficient in MS Word, Excel, Project, and PowerPoint
- Experience with cell therapy or gene therapy is a plus
- Availability to work extended hours such as evenings or weekends to meet deadlines when necessary
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