A2 Biotherapeutics
Location
Agoura Hills, CA | United States
Job description
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 Process Development Engineer to join the team. You will play a pivotal role in advancing our early-stage products into GMP manufacturing and Quality testing facilities. You will also provide subject matter expertise to support clinical manufacturing and/or phase-appropriate method development and optimization. To be successful, you must have CAR T/cell therapy and bioprocessing experience 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:
● Design and execute process/method development studies independently with a thorough understanding of operating and performance parameters. Initiate and propose new processes or methods to improve A2’s manufacturing process or quality testing.
● Develop solutions with detailed plans to study a process or assay parameter or improvement to overcome technical problems with extensive complexity. This includes independently breaking down the problem, testing the hypothesis, and analysis, including relevant controls. Proactively works on developing solutions, asking the right questions and proactively acts to address them.
● Serve as a subject matter expert on one of these areas 1) manufacturing operation units or 2) testing methods with a minimum basic understanding of the other area 1) process and 2) analytical testing methods
● Perform hands-on work in a PD lab and provide trainings for GMP cell therapy clinical production and product/in-process testing.
● Perform statistical analysis, including design of experiments (DOEs) as appropriate. Make recommendations and decisions based on your analysis.
● Develop and execute high-level study design with attention to detail.
● Record and analyze data; interpret and validate results for accuracy and completeness.
● Write and review technical documentation, including SOPs, draft manufacturing batch records, technical reports, testing methods, stability protocol, summary reports, memos, etc.
● Work cross-functionally with preclinical discovery, translational sciences, clinical development, clinical operations, biometrics, regulatory, and safety to execute on corporate goals.
● Builds relationships and actively works to strengthen them with the Process Development team and across A2 with key stakeholders. Openly communicates complex ideas, proposals and recommendations.
● Proves technical advice and coaching to others to strength the Process Development team.
● 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 and 2+ years of cell therapy process/method development experience.
● OR Bachelor's degree in biology, biochemistry, bioengineering or related discipline and 3+ years of cell therapy process/method development experience.
● Plus, must have fundamental knowledge of basic cell culture and aseptic techniques.
Preferred Qualifications
● Ability to independently design and execute creative, high-quality experiments with attention to complex details.
● Ability to interpret, organize, and effectively communicate results in a timely manner.
● Ability to troubleshoot, problem-solve, and multitask while paying careful attention to timelines and priorities.
● Demonstrates knowledge and proficiency in data analysis tools such as Excel, GraphPad Prism, JMP, or other related software.
● Fluency with cGMP manufacturing regulations and requirements.
● Proven track record of critical thinking and scientific/technical aptitude 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.
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 $104,000- $120,000)
● 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.
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