GeneFab · 8 hours ago
Senior Analyst II, Quality Control
Alameda, CA
Full-time
Onsite
Senior Level
$45/hr - $55/hr
5+ years expGeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. In this role, you will support the GMP QC testing at GeneFab, focusing on testing, method transfer, qualification, troubleshooting, and investigations.
BiotechnologyInterior DesignManufacturing
Responsibilities
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
Qualification
Required
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
Able to lift up to 40 pounds
Preferred
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
Comfortable in a fast-paced environment with minimal direction and able to adjust workload based on changing priorities
Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of the initial job description
Company
GeneFab
GeneFab specializes in contract development, manufacturing, and synthetic biology for cell and gene therapies.
51-200 employees
H1B Sponsorship
GeneFab has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
Funding
Current Stage
Growth StageLeadership Team
Philip Lee
Chief Executive Officer
Recent News
2025-05-17
Company data provided by crunchbase