Senior QC Analyst, QC Analytical

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

Job summary

GeneFab, a California-based contract manufacturing and synthetic biology biofoundry, seeks an experienced QC Analytical Analyst to support GMP testing and method transfers for cell and gene therapy products.

The role focuses on QC testing, troubleshooting, investigations, and documentation to ensure cGMP compliance while coordinating with Analytical Development, MSAT, and Manufacturing teams in a fast-paced setting.

Qualifications

• 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 technologies such as multicolor flow cytometry, cell culture, multiplexed immunoassay, qPCR, dPCR methods, Luminex, and ELISA.
• Experience in GMP.
• Experience with contract laboratories and/or CDMO is a plus.
• Knowledge of LIMS and 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 to meet deadlines when necessary.
• Comfortable in a fast-paced environment with minimal direction.

Responsibilities

• Provide technical SME support to Analytical Development and QC Analytical Operations.
• Develop, implement, and update QC SOPs, testing records, and documentation for cGMP compliance.
• Perform QC testing on in-process and final product samples to support release and stability testing.
• Lead root-cause investigations for aberrant results and deviations in analytical methods.
• Train junior employees to ensure testing procedures meet regulations and procedures.
• Plan and execute analytical method transfers, qualifications, and validations.
• Draft, review, and approve Method Transfer Protocols and Reports.
• Generate and review procedures, protocols and reports.
• Identify and lead continuous improvement initiatives in processes and procedures.
• Collaborate with MSAT, ASAT, and Manufacturing to support method optimization and transfers.
• Perform additional duties as assigned.

Skills

GMP experience

Cross-functional collaboration

Attention to detail

Time management

Analytical thinking

Ability to work extended hours

Education

B.S. in biology or related field

Tools

Flow cytometry

qPCR

dPCR

Luminex

ELISA

LIMS

ELN

Job description

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.

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.

About The Role

Genefab is seeking an experienced analyst to join it’s 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.

What You’ll Do

• 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

Qualifications

• 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

The Pay Range For This Role Is

45 - 55 USD per hour(GENEFAB - ALM)