Quality Control Associate
Los Angeles, California
Expiry Date :
Sat, 07 Nov 2020 23:59:59 GMT
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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.
A2 is seeking a highly motivated Quality Control Associate to join A2 Biotherapeutics reporting to the Manager of Quality Control. This position requires a minimum of 2 years cell therapy, pharmaceutical quality control laboratory experience.
To be successful, this candidate must have CAR T/cell therapy Quality Control/GMP manufacturing expertise to execute, collaborate and manage the analytical quality control testing studies to support assay characterization, qualification and Phase 1 manufacturing for cell therapy internally and with external CMOs/CROs. In addition, the candidate must have proven success working in cross-functional teams from pre-clinical, translational, clinical and commercialization.
* Partner 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.
* Perform cell culture work in a QC lab to support cGMP clinical manufacturing
* Document, analyze, and report experimental results to the Quality team
* Operate, qualify and maintain equipment within the Quality Control laboratory
* Participate in lab housekeeping tasks and manage lab consumables
* Follow all Quality standards and environmental health and safety guidelines
* Communicate and collaborate effectively with other team members
* 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 technical SOPs, drafting quality control electronic records, technical reports and summary reports
* Work with sample management and external CMO/CROs
* Work cross-functionally with preclinical discovery, translational sciences, clinical development, clinical operations, bio-metrics, regulatory and safety to execute on corporate goals
* Support the preparation of data packages for regulatory agencies, presentations and publications
* Bachelor’s degree in biology, biochemistry, bioengineering or related discipline and 2+ years of cell therapy pharmaceutical quality control experience
* Must have fundamental knowledge of basic cell culture and aseptic technique
* Ability to design and execute creative, high-quality experiments independently and to interpret and communicate results clearly and quickly
* Ability to troubleshoot, demonstrate problem solving, 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 with demonstrated history of flexibility
* Ability to work effectively, collaborate cross-functionally, and utilize resources efficiently
* Excellent organizational, interpersonal, verbal and written communication skills
At A2 we believe in investing in our team. Our benefits 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.
* 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