Manager, Commercial Manufacturing

The Manager, Commercial Manufacturing oversees the daily operations within our GMP manufacturing facility. This individual will manage the production of cell-based therapies, ensuring adherence to regulatory guidelines, standard operating procedures (SOPs), and quality standards. The successful candidate will play a pivotal role in delivering patient batches with a high degree of safety, quality and reliability while mentoring and guiding a team of Supervisors and support Cell Therapy Production Associates, Oncology. 

Physical Demands

• Production Associate Roles: 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.

Work Conditions

• Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.

Essential Duties & Key Responsibilities:

• People leadership: Supervise and manage manufacturing staff including supervisor and operators to ensure timely execution of production batches.  Coach and develop talent and train team members on SOPs, aseptic techniques, and safety protocols.
• Execution of Manufacturing Activities: Responsible for coordinating production execution activities to meet production schedules and deliver products to quality standards, reliably and on time.  Manage deviations, corrective and preventative actions and change controls and drive continuous improvements in manufacturing execution.
• Compliance & Quality Assurance: Ensure all manufacturing execution activities comply with industry standards and regulations (e.g., GMP, ISO). Work closely with the quality team to ensure that batch manufacturing meets product quality and safety requirements.  Drive needed corrective and preventive actions.
• Continuous Improvement Culture: Foster a culture of continuous improvement within the organization, encouraging employees to contribute ideas, solve problems, and implement solutions that drive improvement in execution.  Drive manufacturing improvements in communication, manufacturing flow and batch execution.
• Cross-Functional Collaboration: Work closely with MSAT, engineering, quality, and supply chain teams to drive daily activities and ensure execution to manufacturing schedules.  Facilitate communication between teams to ensure execution to safety, quality and reliability of batch production.
• Employee Safety: Promotes a safety-first culture reinforcing a mindset of safety as integral to product quality and patient outcomes.  Ensure employee compliance with safety regulations.  Enforce the use of personal protective equipment (PPE), sterile gowning protocols, and ergonomic practices.
• May require shift, weekend, or holiday coverage to support manufacturing and patient treatment timelines.

Minimum Qualifications:

• Bachelor's degree in a relevant field such as Biotechnology, Engineering, Manufacturing or Operations Management; advanced degree preferred.
• 3-5 years of experience in GMP cell therapy, biologics, or pharmaceutical manufacturing environment
• 2-4 years in a people leadership or supervisory role.
• Deep understanding of aseptic processing, closed system operations and cell therapy techniques.
• Excellent analytical, problem-solving, and decision-making skills.
• Organizational, interpersonal and communication skills.

   

Preferred Qualifications:

• Masters or PhD in Chemical Engineering, Biochemistry or Biology is preferred
• 5+ years of leadership experience preferred
• Experience in Cell therapy manufacturing preferred
• Experience with regulatory inspections and cGMP compliance preferred.