Senior Manager, Manufacturing - Berkeley Biologics, LLC

Berkeley Biologics, founded in 2023, manufactures high-quality, cost-effective, clinically relevant human cell/tissue products. The company offers a broad variety of allografts for bone, wound care and soft tissue applications. Berkeley Biologics is a licensed Tissue Bank that is accredited by the AATB.

The Senior Manager of Manufacturing will oversee end-to-end manufacturing operations for tissue processing, ensuring compliance with FDA, AATB, and cGMP standards. They are responsible for driving continuous improvement initiatives, managing the production team, and optimizing processes to maintain high-quality standards and operational efficiency.  This role is onsite in our Richmond, CA office and reports to the VP Operations.

Key Responsibilities:

• Champion a culture of continuous improvement, belonging and employee development.
• Lead the manufacturing team in tissue processing and preservation, ensuring high standards for quality, safety, and compliance with regulatory guidelines.
• Develop, implement, and monitor production schedules to meet demand while optimizing resource allocation.
• Collaborate cross-functionally with Quality, R&D, and Supply Chain to resolve production issues and support new product introductions.
• Drive continuous improvement initiatives to enhance yield, reduce lead times, and improve process efficiencies.
• Oversee SOP development and training programs to ensure team proficiency and adherence to process controls.
• Utilize data analysis to identify trends and drive corrective actions in response to deviations.
• Implement and manage KPIs to monitor production performance and support strategic decision-making.
• Ensure the facility meets all health and safety regulations and guidelines for tissue processing.

Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, or a related field; advanced degree preferred.
• 8+ years of experience in manufacturing within the tissue bank or biologics industry.
• Proven track record in managing manufacturing operations, ideally with experience in tissue processing.
• Familiarity with FDA and AATB regulations, cGMP standards, and tissue banking best practices.
• Strong leadership, problem-solving, and project management skills.

Berkeley Biologics is an equal opportunity employer and does not discriminate on the basis of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, veteran status, or other class protected by applicable law. We are proud to be an equal opportunity workplace.

The base pay range for this position is $120,000 - $160,000.

Berkeley Biologics offers a competitive Benefits package:

• Medical, dental, and vision insurance for employee and family
• Life and disability Insurance
• 401(k) Retirement Plan with employer matching
• Flexible Spending Accounts
• Access to mental health platforms
• Optional coverages employee can purchase for pet insurance, home and auto insurance, additional life and accident insurance, critical illness insurance, group legal, ID theft protection
• Generous Paid Time Off
• 8 Paid Holidays
• A supportive, inclusive atmosphere on a team that values your contributions.  Our people thrive by being themselves and are inspired to do their best work every day.