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Associate Process Development Engineer II

A2 Biotherapeutics

Agoura Hills, CA, US
  • Job Type: Full-Time
  • Function: Manufacturing
  • Industry: Biotechnology
  • Post Date: 04/14/2024
  • Website: www.a2bio.com
  • Company Address: 30301 Agoura Road, Suite 210, Agoura Hills, CA 91301, US

About A2 Biotherapeutics

A2 is dedicated to pushing the boundaries of science to transform medicine and turn the tide on cancer. We are focused on the next frontier in cell therapy: solid tumors.

Job Description

Associate Process Development Engineer II

Technical Operations, Los Angeles, California, 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.

 

A2 is seeking a highly motivated Associate Process Development Engineer II to join the team. You will play a pivotal role in advancing our early-stage product into GMP manufacturing, and provide subject matter expertise to support clinical manufacturing process development, continuous improvement etc. To be successful, you must have CAR T/cell therapy and bioprocessing experience in order to execute process development studies, support technology transfers, and collaborate with internal and external CMO/CROs partners. In addition, the ideal candidate must have proven success working in cross-functional teams from Quality, Manufacturing, Supply Chain and Research.  

 

This is an onsite position at our Process Development facility in Agoura Hills, CA. If you are seeking an opportunity that fosters growth and challenge….apply now! 

Responsibilities:

  • Perform hands-on work in a Process Development lab and provide routine lab support for GMP cell therapy clinical production/in-process testing.
  • Contributes scientifically and in the execution of larger process development experiments and/or deliverables that impact their work and/or process development and/or cross-functional milestones. Executes with demonstrated individual accountability and others.
  • Design and execute process development studies with attention to details and under limited supervision.
  • Contributes to completing process development milestones to support our early-stage clinical programs.
  • Perform statistical analysis including design of experiments (DOEs) as appropriate.
  • Record and analyze data; interpret and validate results for accuracy and completeness; meticulous record keeping from work performed.
  • Assist in drafting and reviewing technical documentation, including SOPs, manufacturing batch records, and development reports.
  • Work cross-functionally with discovery research, translational sciences, clinical development, clinical operations, biometrics, regulatory, and safety for the execution of corporate goals. 
  • Build relationships within the Process Development team and collaborate with manufacturing, quality, and discovery research staff.
  • Support the preparation of data packages for regulatory agencies, presentations, and publications.

Requirements

 

Basic Qualifications:

  • Master’s degree in biology, biochemistry, bioengineering, or related discipline with at least 1+ years of cell therapy manufacturing and/or process development experience.
  • OR Bachelor's degree in biology, biochemistry, bioengineering or related discipline with at least 2+ years of cell therapy manufacturing and/or process development experience.
  • Must have fundamental knowledge of GMP cell culture and analytical techniques. 

Preferred Qualifications

  • Ability to execute high-quality experiments with attention to details and work under moderate supervision.
  • Understanding of cell therapy manufacturing unit-operations such as cell selection, transduction, cell culture, and formulation.
  • Experience in in-process testing such as cell count and flow cytometry analysis.
  • Understanding of basic cGMP and regulatory requirements for cell therapy manufacturing and/or QC release and stability testing
  • Skilled in leveraging process and method knowledge to determine appropriate actions, as well as developing solutions to technical problems in consultation with the supervisor. 
  • Ability to organize and effectively communicate results to supervisor and immediate team in a timely manner.  
  • Ability to multitask and prioritize assigned duties based on critical team needs. 
  • Demonstrates knowledge and proficiency in data analysis tools such as Excel, GraphPad Prism, JMP, or other related software. 
  • Proven track record of critical thinking and scientific/technical aptitude through completion of project activities and scientific literature review.
  • 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.

 

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 (Annual salary range for this position is $86k - $95k))
  • 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
  • Paid parental leave
  • Environment where professional development is actively encouraged and supported.

 

Equal Opportunity Statement:

A2 is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability status.

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