Senior Analyst, Quality Control Analytical

GeneFab; Alameda (CA); On-site; USD 62,000 - 76,000; Full time

Job summary

GeneFab is seeking an experienced QC Analyst to join its Quality Control Analytical group in support of GMP QC testing, method transfer, qualification, troubleshooting, and investigations. You will lead investigations, develop SOPs, and collaborate across MSAT, ASAT, and Manufacturing to ensure cGMP compliance.

The role requires at least 5+ years of GMP/QC laboratory experience and a BS in biology or a related field. Availability for extended hours may be needed to meet deadlines.

Qualifications

• B.S. degree in biology or related field with GMP/QC experience.
• Proven ability to collaborate across teams.
• Strong organizational skills and attention to detail.
• Experience with analytical methods and QC testing.

Responsibilities

• Provide SME technical support to Analytical Development and QC Analytical Operations.
• Develop, update, and maintain QC SOPs, testing records, and cGMP documentation.
• Perform QC testing on in-process and final product samples for release and stability.
• Lead and perform root-cause investigations for deviations in analytical methods.
• Plan and execute method transfers, qualifications, and validations.
• Draft and review Method Transfer Protocols and reports.
• Collaborate with MSAT, ASAT, and Manufacturing for method optimization and troubleshooting.

Skills

GMP/QC expertise

Cross-functional collaboration

Analytical troubleshooting

Time management

Education

BS in Biology or related field

Tools

LIMS

ELN

MS Office

Job description

Genefab is seeking an experienced analyst to join its Quality Control Analytical group. In this role, you will support the GMP QC testing at GeneFab, with a focus on testing, method transfer, qualification, troubleshooting and investigations.

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

Requirements

• 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
• 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
• Able to lift up to 40 pounds

$45 - $55 an hour

About GeneFab

GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.

We are committed to an inclusive and diverse GeneFab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.