Role Overview
This position is responsible for performing manufacturing procedures and executing scheduled tasks within a cGMP environment, ensuring quality and compliance with company policies, procedures, and applicable regulations.
Key Responsibilities
- Produce autologous CAR-T products for clinical and commercial operations in a controlled cGMP cleanroom.
- Independently execute manufacturing and manufacturing-support processes per SOPs/curriculum.
- Perform cell culturing, purification, aseptic processing, and cryopreservation.
- Execute process unit operations per SOPs/batch records and record data per Good Documentation Practices (GDP).
- Complete tasks on time per quality systems and cGMP requirements.
- Work cross-functionally in a team environment to complete shift-based production tasks.
- Assist in development of manufacturing processes and associated documentation.
- Support continuous improvement; handle human-derived materials in containment areas.
- Ensure materials availability, support investigations, and participate in audits.
- Maintain clean/safe work environment; eliminate hazards and communicate unsafe behaviors.
- Wear required PPE and perform gowning procedures.
Requirements
- HS Diploma (3β5 years biotech/pharma) OR Associate degree (Life Sciences/Manufacturing, 2β3 years) OR Bachelorβs degree (Life Sciences, 0β2 years).
- Ability to interpret instructions; follow directions; solve practical problems with limited standardization.
- Basic math skills; knowledge to operate manufacturing/support/lab equipment.
- Process Excellence Tools knowledge.
- Solid knowledge of routine and non-routine testing/sampling.
- Must be mobile; communicate frequently; stand/walk/climb/bend/stoop/reach; lift 25 lbs.
- Visual acuity 20/40 (Snellen) or better and color perception 5/8.
Benefits and Pay
- Base pay range: $59,168β$77,658 USD.
- Other types of pay: performance-based bonus and/or equity (eligible roles).
- Medical, dental, and vision; 401(k) match; 8 weeks paid parental leave after 3 months; paid time off (vacation, personal, sick, floating holidays, and 11 company holidays); additional voluntary benefits (as listed).
Note
- Benefits are for permanent full-time employees; contractors are not eligible.