Supervisor, Commercial Manufacturing - Day Shift

Orca Bio•Sacramento, CA

13h•Onsite

About The Position

The Supervisor, Commercial Manufacturing plays a critical role overseeing the production of Orca’s cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position works on shift to provide supervision and direction to Associates, Cell Therapy Production, Oncology to ensure timely and compliant manufacturing.

Requirements

B.S. degree required in biology or related field
2+ years of supervisory or team experience is required
Strong understanding of aseptic manufacturing practices and clean room operations
Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed.
Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
Ability to gown and work in clean rooms and Biosafety safety cabinets
Highly detail oriented with special attention to quality
Strong interpersonal skills and ability to communicate effectively
Ability to work in a collaborative manner
Ability to work independently and as part of a team
Highly tolerant and respectful of all team members
Must be able to remain in a stationary position 50% of the time while in a biosafety cabinet/cleanroom environment which includes wearing a PPE gown
Follow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition
Occasional need to ascend/descend stairs within workspace; job requires standing/walking

Nice To Haves

M.S. degree in biology or related field
Prior experience in cell therapy or other advanced biologics
Familiarity with deviation investigations, CAPAs and change control processes
Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment
A sense of humor is always appreciated
Strong problem-solving skills

Responsibilities

Supervise and lead a team of associates, cell therapy production, oncology during assigned shift operations.
Coordinate daily manufacturing activities to meet schedule, and quality and compliance goals.
Execute and enforce cGMP-compliant SOPs, batch records, and safety procedures
Provide on-the-floor training, mentorship, and performance feedback to production staff
Monitor and troubleshoot production activities and equipment, escalating as needed
Partner with QA and QC to support in-process checks, deviation investigations, and batch record reviews
Maintain real-time, accurate documentation of manufacturing processes and equipment use
Support continuous improvement initiatives to increase reliability and efficiency.
Participate in CAPA and deviation investigations related to manufacturing activities