Sr. Quality Control Associate
A2 Biotherapeutics, United States
Job Description
At A2, our mission is to extend the reach of cell therapy to tackle the next frontier in cancer treatment: solid tumors. Our team is dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illness. Central to achieving this mission is our focus on recruiting the best talent and building an environment that enables our team to do the best work of their careers and make an impact on patients and society at large.
We are seeking a highly motivated Sr. Quality Control Associate to join our team reporting to the Manager of Quality Control. In this role, you will execute and manage the analytical quality control testing studies to support assay characterization and qualification and Phase 1 manufacturing for cell therapy both internally and collaborating with external CMOs / CROs.
This position requires a minimum of 5 years of cell therapy pharmaceutical quality control experience. Strong laboratory skills are a must. In addition, you must have a proven track record of working in cross-functional teams from preclinical, translational, clinical and commercialization. If you are looking to join a fun, fast paced amp; growing team in a cell therapy / tech ops environmentapply today!
Responsibilities:
- Work with the Tech Ops group to ensure the integrity of cell therapy products.
- Perform hands-on laboratory testing utilizing various analytical techniques including ddPCR, flow cytometry, cell counting, cytotoxicity assays and microbiology techniques, in support of cGMP clinical manufacturing.
- Support analytical tech transfer from research and process development to quality control.
- Operate, qualify and maintain equipment within the Quality Control laboratory.
- Follow all Quality standards and environmental health and safety guidelines.
- Document and perform quality investigation to support out-of-specification investigations and data summaries for material review boards.
- Perform statistical and analytical analysis of experiments as appropriate to ensure analytical assay trending and control.
- Provide data summaries to support internal quality review meetings.
- Write and review technical documentation including writing SOPs, draft quality control electronic records, technical reports and summary reports.
- Support the preparation of data packages for regulatory agencies, presentations and publications.
- Work with sample management and external CMO/CROs to establish phase appropriate quality/compliance requirements.
- Collaborate with Quality team/SMEs to establish phase appropriate/FIH (First In Human) GMP compliance plan for QC lab.
- Work cross-functionally with preclinical discovery, translational sciences, clinical development, clinical operations, biometrics, regulatory and safety to execute on corporate goals.
- Must be available to work weekend shifts and extended shifts as necessary.
Requirements
Basic Qualifications:
- Bachelor's degree in biology, biochemistry, bioengineering or related discipline and 5+ years of cell therapy pharmaceutical quality control experience.
- Must have fundamental knowledge of basic cell culture and aseptic technique.
Preferred Qualifications:
- Ability to design and execute creative, high-quality experiments independently and to interpret and communicate results clearly and quickly.
- Ability to troubleshoot, problem solve and multitask while paying attention to timelines and priorities.
- Proven track record of critical thinking and scientific achievement as demonstrated by patents or publications in highly regarded scientific journals.
- Highly motivated, proactive and enthusiastic team player who builds strong relationships with colleagues and partners.
- Ability to work independently, collaborate cross-functionally, and utilize resources efficiently.
- Excellent organizational, interpersonal, verbal and written communication skills.
Benefits
At A2 we believe in investing in our team. Our benefits programs are just one of the many ways we strive to help our employees take care of themselves and their families. We offer a variety of programs, from comprehensive medical insurance to generous time off policies designed to help meet the needs of our diverse team.
Benefits include:
- Competitive base salary and annual incentive opportunities
- Equity participation
- Comprehensive health and welfare benefits (including medical, dental, vision, life, disability, and accident insurance)
- Wellness and recognition programs
- Paid time off and holidays
- Flexible work arrangements
- Environment where professional development is actively encouraged and supported.