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.
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
