A2 is seeking a highly motivated Manufacturing Engineer to join A2 Biotherapeutics reporting to the Senior Engineer of PD/Manufacturing. This position requires a minimum of 3 years of pharmaceutical manufacturing and quality experience.
To be successful, this candidate must have cGMP manufacturing and cell culture processing expertise to manufacture T cell products and collaborate on process development laboratory studies for technical transfer to clinical manufacturing
Responsibilities (include, but are not limited to):
- Independently exercises good scientific and engineering judgement in performance of the following job duties including process development to create a new manufacturing process, T-cell manufacturing, mathematical modeling and statistical analysis
- Must be able to follow and perform all tasks in SOPs and batch records for cGMP cell therapy clinical production; Weekend and holiday shift work required to support clinical patient lots
- Aseptic cell processing, reagent preparation, cell counting and flow cytometry
- Write and review technical SOPs, protocols, and reports for process and equipment
- Revise and update manufacturing batch records
- Perform equipment installation and operational qualifications for cGMP cell processing instruments
- Support tech transfer of manufacturing processes from process development to manufacturing
- Perform process development studies to develop a thorough understanding of operating and performance parameters
- Ensure product, sample, and data integrity
- Investigate quality deviations and write-up investigations
- Manage inventories for consumables and reagents, must be able to lift over 45lbs
- Other duties as applicable
- Education: Bachelor of Science degree in engineering, biology, or biochemistry degree or related discipline
- Experience: 3+ years of pharmaceutical manufacturing, process development, CROs & quality experience
- Must be able to work during weekends and flexible with extended shifts
All your information will be kept confidential according to EEO guidelines.
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.