Senior Analyst, Quality Control Analytical

Team: Quality Control

Location: Alameda, CA

Commitment: Full-Time (4x10shift | weekend shift)

Workplace Type: onsite

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