Manager, Quality Control Analytical
ImmPACT Bio USA
ImmPACT Bio is a clinical-stage company, headquartered in the Los Angeles area, developing novel cell therapies for treating cancer and autoimmune disease. The company’s next-generation chimeric antigen receptor (CAR)-T cell technologies are based on Boolean logic-gate approaches and address key biological challenges for engineered T cell therapies including relapse due to antigen loss/escape; on-target, off-tumor toxicities; and the immunosuppressive tumor microenvironment.
ImmPACT-Bio is seeking a highly motivated individual to join us as a Manager in the Quality Control (QC) organization. As a Manager of QC Analytical, you will play a critical role in ensuring the safety, quality, and efficacy of our cutting-edge cellular therapies in support of Clinical and future Commercial Manufacturing of the new GMP cell therapy production facility located in West Hills, CA. The candidate will have significant cross-functional interaction with personnel from Process Development, Analytical Development, Quality Assurance, Manufacturing, and Project Management on all aspects of cGMP manufacturing. Experience in start-ups is essential. The candidate should also have a phase-appropriate mindset and a deep understanding of quality control practices, with strong leadership abilities to guide a team toward excellence.
This full-time position reports to the Director of Quality Control.
- Hire, lead, mentor, and develop a team of high-performing QC associates, fostering a culture of quality, teamwork, continuous improvement, accountability, and adherence to safety procedures/policies.
- Assess, plan, and manage resource allocations for QC Analytical
- Develop/Implement a strategy for raw material, analytical product release testing, and stability programs for maintaining product quality, aligning them with the regulations and organization's quality objectives.
- Oversee day-to-day operations associated with the raw material, release, and stability testing of clinical cell therapy products.
- Collaborate with the Analytical Development team to develop, optimize, and transfer assays including but not limited to cell counting, viability, purity, and potency assays (ddPCR, Flow Cytometry, and ELISA).
- Lead the Qualification/Validation activities and will be responsible for routine lot release testing of CAR T-cell therapy products to ensure compliance with regulatory requirements and quality standards.
- Expectation includes a hands-on approach to problem-solving/troubleshooting activities, planning, generating/approving CoAs for product release, developing, authoring, revising, and reviewing SOPs/Forms, release data, CoA, SOPs, protocols, and reports.
- Responsible for leading lab investigations, OOS, protocol deviations, change controls, CAPA, data trending, preparing control charts/metrics, and implementation to maintain robust quality systems.
- Oversee purchase and qualification of equipment/materials and manage inventory.
- Collaborate with cross-functional teams, including Quality Assurance, manufacturing, research and development, and regulatory affairs, to support product development and release.
- Contribute to the design, implementation, and continuous improvement of QC systems.
- Interact with Regulatory Agencies as the QC subject-matter expert during inspections.
- Support departmental, Quality, and facility projects as needed.
- Additional duties as assigned.
- Bachelor of Science with six (6) years of experience, or Master of Science with four (4) years of experience, or Ph.D. with one (1) year of experience or equivalent amount of education and experience
- The ideal candidate will be an independent and adaptable professional with substantial experience in cell therapy, possessing the ability to oversee all aspects of quality control activities and transition seamlessly from clinical to commercial environments.
- Profound knowledge of analytical test methods involving cell culture, Flow cytometry, ELISA, PCR, qPCR, ddPCR, automated cell counter, and spectroscopy is a plus.
- Detail-oriented with an unwavering commitment to quality and patient safety.
- Proven leadership experience including team and project management with strong analytical and problem-solving abilities.
- Ability to effectively negotiate and build collaboration amongst individual team members.
- Expertise in working with Process Development, QC, Manufacturing, Research, Translational Sciences, and CMC Regulatory.
- Familiarity with FDA, ICH, and GMP guidelines; professional certifications are advantageous.
- Extensive experience in conducting lab investigations, writing deviation reports, implementing CAPA, and initiating/implementing change controls.
- Experience with a Lab Information Management System is a plus (LabVantage, Sample Manager, LabWare, StarLIMS or similar).
- Excellent skills in Microsoft Office, data analysis software, and other related applications.
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
- Comfortable in a fast-paced small startup company environment with minimal direction and able to adjust workload based upon changing priorities.
Compensation for the role will depend on several factors, including a candidate’s qualifications, skills, competencies, and experience.
ImmPACT Bio provides a generous Total Rewards package, to include a competitive base salary, bonus, and equity package as well as generous benefits and paid time off programs. ImmPACT Bio is an Equal Opportunity Employer and will review all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. All information will be kept confidential according to EEO guidelines.