Supervisor, Cell Therapy External Manufacturing

About Sonoma Biotherapeutics:

Sonoma Biotherapeutics is a South San Francisco and Seattle-based company leading the development of adoptive T-reg therapies cell for autoimmune and degenerative diseases. Using next generation genome editing and target-specific cell therapy, Sonoma is focused on developing its best-in-class platform across the entire spectrum of T-reg cell therapeutic capabilities. Founded by pioneers in Treg biology and cell therapy, the company brings together leading expertise and proprietary methodologies for the discovery and development of disease modifying and curative therapies. More information at www.sonomabio.com. 

Job Purpose/Summary:

The Manufacturing Supervisor reports directly into the Sr. Manager, External Manufacturing and works closely with Quality Assurance, Supply Chain, Patient Operations, and CMC project teams. The initial focus of this role is to provide support to all aspects of external manufacturing activities at contract development and manufacturing organizations (CDMOs), including GMP manufacturing of cell therapy products and critical starting materials to ensure timely supply of materials to meet established project timelines. 

Role and Responsibilities:

• Support manufacturing activities for cell therapy products and intermediates
• Demonstrate high learning agility and willingness to become a cell therapy product manufacturing process expert
• Identify strategic and operations issues to prevent deviations maintain a compliant Manufacturing environment
• Perform in-process batch record review to ensure appropriate documentation prior to review by Quality Assurance
• Support manufacturing metric reporting to monitor key manufacturing attributes, implementing corrective and preventive actions as needed
• Serve as person in plant (PIP) during critical cell therapy product manufacturing steps
• Provide tracking support for manufacturing documents
• Draft, review, and approve Manufacturing documentation, as appropriate
• Identify and implement process improvements

Qualifications and Education Requirements:

• Bachelor’s degree in Science or Engineering and 5+ years of pharmaceutical industry experience, at least two years of which must involve a role in cell therapy manufacturing

• Demonstrated knowledge of the application of cGMPs applicable to biologics and cell therapy manufacturing

• Ability to translate complex issues into a meaningful set of recommendations

• Excellent communication, trouble shooting, and problem-solving skills

• Ability to build and maintain strong relationships, influence, and work well with others in a proactive and constructive manner

Preferred Skills:

• Ability to anticipate operational issues and proactively recommend solutions/mitigations
• Previous experience with flow cytometry
• Experience supporting a GMP facility start-up and contract development and manufacturing organizations (CDMOs),
• Background in aseptic gowning and qualification and ISO class 7 cleanroom operations

Competencies Needed: 

• Attention to detail
• Asking the right questions
• Art of listening
• Team player
• Effective time management
• Problem solving
• Ability to manage multiple priorities
• Effective communication skills

Travel: 

• In the first year in this role, travel to our CDMO in Philadelphia is expected to be 40% - 50%, or 8-10 business days per month

Other duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.