Manufacturing Supervisor, Upstream

Tanvex CDMO; San Diego (CA); On-site; USD 88,000 - 105,000; Full time

Job summary

An established industry player is seeking a dynamic supervisor to lead the upstream team in a GMP manufacturing environment. This pivotal role involves overseeing critical processes such as cell banking, fermentation, and production planning, ensuring compliance with stringent cGMP standards. The ideal candidate will bring extensive experience in biotech or pharma, coupled with strong managerial skills and a collaborative spirit. If you thrive in a fast-paced environment and are passionate about advancing biomanufacturing, this opportunity offers a chance to make a significant impact within a forward-thinking company.

Qualifications

• 9+ years in biotech/pharma or 12+ years in manufacturing.
• 2+ years of managerial experience required.
• Knowledge of cGMP and biologics regulations essential.

Responsibilities

• Oversee upstream team and operations in GMP manufacturing.
• Manage staffing, production planning, and compliance.
• Collaborate with QA, QC, and engineering departments.

Skills

Team Collaboration

Technical Writing

Problem-Solving

Effective Communication

Knowledge of Biologics Regulations

Experience with CAPAs

Proficiency in MS Office

Education

B.S. in Engineering/Science

M.S. in Engineering/Science

High School Diploma/GED

Tools

GMP Practices

Biologics Manufacturing Systems

Quality Systems

Job description

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Description

SUMMARY

Under general guidance, the supervisor will oversee the upstream team and perform upstream unit operations in a GMP manufacturing setting. Responsibilities include managing the GMP facility, production planning, upstream processes (cell banking, vial thaw, seed cell expansion, fermentation, harvest, cell lysis, inclusion body), GMP training, and improvement projects. The supervisor ensures timely delivery of production activities, maintains SOPs and batch records per cGMP standards.

Job Responsibilities

Essential Functions

Staff Management

• Responsible for staff performance and development
• Recruitment, hiring, training, and performance evaluation
• Coach and mentor team members
• Ensure quality of training programs
• Assist in organizational structuring

Technical

• Supervise upstream operations in GMP manufacturing
• Manage staffing and shift planning
• Control inventory and production schedules
• Ensure safety and develop solutions for manufacturing issues

Cross-functional Collaboration

Work with QA, QC, engineering, R&D, and other departments.

Documentation

Maintain accurate logs, batch records, and reports following GMP practices.

Compliance

• Lead deviation investigations, CAPAs, change controls
• Ensure GMP and 21CFR compliance
• Develop and revise SOPs and batch records
• Support audits and investigations as SME

Other duties as assigned.

Job Requirements

Education & Experience

• B.S. in engineering/science with 9+ years or M.S. with 6+ years biotech/pharma experience, or a high school diploma/GED with 12+ years manufacturing experience
• Minimum 2 years managerial experience
• Knowledge of biologics regulations and cGMP
• Experience with biologics manufacturing and quality systems
• Production planning experience preferred

Skills & Abilities

• Strong team collaboration skills
• Experience with deviations, CAPAs, and cross-functional communication
• Technical writing and presentation skills
• Knowledge of mammalian cell culture or fermentation platforms
• Proficiency in MS Office
• Effective communication skills
• Problem-solving abilities
• Ability to work safely with pressurized systems, chemicals, and in controlled environments

Work Environment & Physical Demands

• Up to 25% office work; standard office equipment used
• Requires talking, hearing, visual acuity, and physical activities including sitting, standing, climbing, and lifting
• Gowning and PPE required for manufacturing areas
• Potential exposure to bio cultures, hazardous chemicals, and thermal hazards
• Flexible hours, overtime, and shift work may be necessary

Salary Range

$88,400 - $105,000