- Job Type: Full-Time
- Function: Life Sciences QA/QC
- Industry: Biotechnology
- Post Date: 08/02/2022
- Website: www.a2bio.com
- Company Address: 30301 Agoura Road, Suite 210, Agoura Hills, CA, 91301
About A2 BiotherapeuticsA2 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.
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 to join our team reporting to the Senior Quality Control Associate. In this role, you will perform and evaluate the analytical quality control testing studies to support assay characterization and qualification and Phase 1 manufacturing for cell therapy – collaborating with internal partners and external CMOs / CROs.
If you are looking to join a fun, fast paced & growing team in a cell therapy/tech ops environment…apply today!
Execution of complex biological assays with high technology instrumentation per SOPs
- Perform hands-on laboratory testing utilizing various analytical techniques including ddPCR, flow cytometry, cell counting, and cytotoxicity assays in support of cGMP clinical manufacturing.
- Perform cell culture work to support cGMP clinical manufacturing.
- Perform statistical and analytical analysis of experiments as appropriate to ensure analytical assay trending and control; contribute to data packages for regulatory agencies, presentations, and publications.
- Write and revise SOPs and technical / summary reports with some supervision.
Execution of QC assay studies or qualifications to meet laboratory GMP requirements under supervision
- Support analytical technology transfer from Research and Process Development to Quality Control.
- Perform and document quality investigations to support out-of-specification results and data summaries.
General QC laboratory maintenance and EH&S
- Operate, qualify, and maintain equipment within the Quality Control laboratory.
- Follow all Quality standards and environmental health and safety guidelines.
- Support setup and implementation of a Quality Control Laboratory.
Continuous improvement of Assay procedures
- Author continuous improvement of Assay procedures under supervision
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.
- Bachelor's degree in biology, biochemistry, bioengineering or related discipline and 2+ years’ experience in the biotech/biopharmaceutical setting OR
- Master’s degree in biology, biochemistry, bioengineering or related discipline with 1+ years’ experience in the biotech/biopharmaceutical setting
- 1+ year experience of cell culture experience in a biotech/biopharmaceutical setting.
- Familiarity with various cell based and molecular biology assays: Flow cytometry, ELISA, PCR, and other methods in a Quality Control Laboratory.
- Knowledge of current Good Manufacturing Practices (cGMPs), GxP, and regulatory requirements pertaining to Quality Control requirements.
- Possess strong project and time management skills.
- Ability to collaborate with cross-functional teams in a fluid, fast-past environment.
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.
● 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
● Paid parental leave
● Environment where professional development is actively encouraged and supported.
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.
A2 requires all staff to be vaccinated against COVID-19 as a condition of employment. In accordance with applicable law, A2 will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief.