Quality Control Senior Associate Scientist
A2 Biotherapeutics, United States

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 Quality Control Associate Scientist to join our team reporting to the Head of Quality Control. In this role, you will lead implementation of a LIMS system and execute analytical quality control testing and Phase 1 manufacturing for cell therapy both internally and collaborating with external CMOs / CROs.

If you are looking to join a fun, fast paced amp; growing team in a cell therapy / technical operations environmentapply today!

The position is located at our facility in Agoura Hills, California.

Responsibilities

• Work with the Technical Operations groups to ensure the integrity of cell therapy products.

• Supervise a team of QC Associates
  • Responsible for planning, coordinating, and supervising activities conducted by QC Analytical Associates
  • Develop and manage the QC Analytical training program

• Responsible for execution of complex biological assays with high technology instrumentation
  • This position requires strong bioassay knowledge
  • Perform and review hands-on laboratory testing utilizing various analytical techniques including ddPCR, flow cytometry, and cytotoxicity assays, in support of cGMP clinical manufacturing per SOPs.
  • Coordinate and perform routine cell maintenance and banking
  • Generate CoA for product release

• Collaborate intra- and inter-departmentally to develop and improve processes and methods
  • Develop and execute assay qualifications
  • Author continuous improvement of methods and processes
  • Create, revise, or review technical documentation including SOPs, quality control electronic records, technical reports and summary reports.
  • Perform statistical and analytical analysis of experiments as appropriate to ensure analytical assay trending and control

• Organize and review data to support the preparation of data packages as appropriate
  • Document and trend invalids and perform quality investigation for investigations of out-of-specification results for material review boards.
  • Contribute to data packages for internal quality review meetings and regulatory agencies, presentations, and publications.

• General QC laboratory maintenance and EHamp;S
  • Operate and maintain equipment in a GMP qualified state within the Quality Control laboratory.
  • Follow all Quality standards and environmental health and safety guidelines.

• Work cross-functionally with preclinical discovery, translational sciences, clinical development, clinical operations, biometrics, regulatory and safety to execute on corporate goals.

• Establish a phase appropriate GMP compliance plan through collaboration with the Quality team and ensure compliance to established SOPs, policies, cGMPs, and other relevant regulatory requirements .

• Must be available to work weekend shifts and extended shifts as necessary.

• Other duties as assigned

Requirements

Basic Qualifications:

• Bachelor's degree in biology, biochemistry, bioengineering or related discipline and 5+ years of cell therapy pharmaceutical quality control experience

OR

• Master’s degree in biology, biochemistry, bioengineering or related discipline and 3+ years of cell therapy pharmaceutical quality control experience
• Must have strong organizational skills and understanding of laboratory operations and bioassays.

Preferred Qualifications:

• Ability to design and execute projects independently and to 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.
• Experience working in cross-functional teams from Research, Translational, Quality, Process Development and Clinical.
• Highly motivated, proactive and enthusiastic team lead who builds strong relationships with colleagues and partners.
• Ability to work independently, collaborate cross-functionally, and utilize resources efficiently.
• Excellent interpersonal communication skills, both written and verbal.

Benefits

At A2 we believe in investing in our team. Our benefits programs are just one of the many wa

Job Rewards and Benefits