About Nucleus Biologics:

At Nucleus Biologics, we are passionate about supporting the development of groundbreaking discoveries and improving the quality of life for patients. Our cell culture products and services fuel today’s therapies and tomorrow’s innovations.

Cell culture media is a critical raw material used in the development of cell-based projects. As the Cell Performance Company™, we are the leading provider of custom cell growth media, tools, and technologies that support every stage of development from research through commercialization. We are committed to delivering premium products and services through a transparent, consistent, and proven supply chain that eliminates variability.

About the role

• The Manufacturing Supervisor is responsible for supervising the manufacturing team, overseeing the maintenance and compliance of cleanroom operations, and driving a culture of performance through targeted training and development. This role offers significant opportunities for growth within a fast-paced and expanding organization.

RESPONSIBILITIES:

Raw materials, consumables and asset management

• Oversee and coordinate inventory activities, including raw materials, consumables, and finished products.
• Supervise equipment maintenance programs, ensuring routine calibration, cleaning, and preventive maintenance tasks are completed on schedule.
• Develop and monitor systems for asset tracking and control, ensuring data accuracy and traceability.
• Inventory management of finished product, raw materials and consumables used in manufacturing.

Production Operations Supervision

• Lead daily production operations in alignment with the production schedule; assign tasks and monitor team performance.
• Ensure training compliance for all personnel prior to batch record execution.
• Act as site lead for technician-level staff when required.
• Contribute to strategic planning related to resource utilization and capacity management.

Compliance & Documentation

• Enforce compliance with cGMP, GDP, and internal quality standards across all production and material handling processes.
• Approve updates to process documentation, including SOPs and work instructions, and ensure document control adherence.
• Review and approve Quality Events, including deviations and non-conformances; drive root cause analysis and CAPA development.
• Support operational readiness for audits and inspections.

Continuous Improvement & Troubleshooting

• Lead cross-functional troubleshooting efforts for production-related issues, collaborating with Quality, Facilities, and Document Control teams.
• Champion and implement continuous improvement initiatives using Lean Six Sigma, or other process improvement methodologies.
• Process Improvement: Identify areas for improvement in production processes and implement strategies to enhance efficiency and reduce costs.
• Supervise validation and preventative maintenance schedules and ensure timely completion by assigned personnel.

Team Leadership & Development

• Provide direct supervision, coaching, and development for a team of technicians.
• Schedule and coordinate training to ensure operational effectiveness.
• Conduct performance evaluations and support professional growth of team members.
• Serve as point of contact for escalations, resource planning, and workflow prioritization.
• Act as site lead for technician-level staff when required.

Cleanroom Management

• Ensure team compliance with gowning procedures, cleanroom behavior policies, and routine cleaning schedules.
• Coordinate and document routine cleaning and sanitization.
• Train and audit staff on aseptic techniques and cleanroom best practices to maintain regulatory compliance.
• Strong leadership, communication, and organizational skills are essential. Technical knowledge of manufacturing processes and associated machinery.

REQUIREMENTS:

EDUCATION:

Bachelor Degree Required BS/BA in Biology/Immunology a plus.

KNOWLEDGE AND EXPERIENCE:

• Requires 3+ years experience in liquid bioprocess manufacturing.
• Prior experience working in cGMP environment

SKILLS AND ABILITIES:

• Strong attention to detail and organization
• Leadership and continuous improvement
• Training and collaboration
• Experience in formulation or media manufacturing
• Cell culture experience is a plus
• Ability to communicate effectively both orally and in writing and to establish and maintain productive working relationships
• Ability to exercise independent judgment consistent with Company guidelines

PROBLEM SOLVING AND DECISION MAKING:

• Develop solutions to a variety of complex problems; ensures solutions are consistent with organization objectives

PHYSICAL REQUIREMENTS:

• Ability to hear and speak to employees and external associates on the phone and in person.
• Ability to see the letters and numbers on a personal computer screen and on memos, reports, and other documents (near vision)
• Ability to walk and/or drive between buildings on campus, up to .3 miles for San Diego-based positions
• Ability to lift at 25 lbs. to a height of 3-4 feet on a regular basis.

TRAVEL REQUIREMENTS:

• May require travel to and from Nucleus Biologics offices or customer/vendor locations based on position.

NOTE: The above statements describe the general nature and level of work being performed. They are not an exhaustive list of all responsibilities, duties, or skills required. Duties may change at any time, and reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

The pay range for this role is:
36 - 40 USD per hour(San Diego, CA)