Manager Operations USP

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Job Description – Upstream Operations Manager

Business Title: Manager, Upstream Operations

1. Position in the Organization

Reports to: Senior Manager, Manufacturing Operations

Direct reports: Supervisors and Technicians, Upstream Processing (USP)

2. Purpose of the Job

The Upstream Manager leads and is responsible for upstream manufacturing operations for biopharmaceutical products at the Thermo Fisher Scientific site in Groningen.

This position ensures that all cell culture activities—from vial thaw through to harvest—are delivered safely, efficiently, and in full compliance with cGMP and international quality standards (FDA, EMA, ICH). The Upstream Manager provides technical direction and leadership to the team, driving operational excellence, timely batch delivery, and staff development while maintaining Thermo Fisher’s commitment to quality and continuous improvement.

3. Job and Position Context

Thermo Fisher Scientific’s Groningen site operates as a Contract Development and Manufacturing Organization (CDMO) supporting biopharmaceutical clients ranging from small biotech firms to global pharmaceutical companies.

The Biologics Operations department focuses on producing monoclonal antibodies and recombinant proteins using mammalian cell culture systems. Manufacturing processes are designed in Process Development and transferred into Operations for execution under cGMP conditions to support both clinical and commercial production.

The Upstream team, leads pre-culture preparations, cell culture operations in single-use bioreactors (SUBs), and clarification. The work environment is multifaceted, with multiple ongoing client projects, frequent technology transfers, and continuous improvement initiatives. Each year, several new manufacturing processes are introduced, and new technologies and automation tools are implemented to keep the site at the forefront of biologics manufacturing.

Given the diversity of customers and the high value of intermediates and products, production activities must be tightly controlled and driven with precision. Compliance with cGMP, EH&S, and Thermo Fisher’s Quality Management System is essential to protect product quality and ensure the site’s license to operate.

The Upstream Manager combines strong technical understanding of mammalian cell culture with the leadership skills needed to guide a multidisciplinary team in a fast-paced, customer-focused environment. A proactive approach and Green Belt certification are required to drive process improvements and operational efficiency through Lean and Six Sigma methodologies.

4. Key Responsibilities

Operational Leadership

• Manage daily production activities in the upstream manufacturing process, guaranteeing safety protocols, regulatory adherence, and production targets are met.
• Be responsible for thaws, inoculation, culture growth, and harvest activities according to approved batch records and SOPs.
• Act as the primary point of contact for upstream operations during batch execution and issue resolution.

People Management

• Lead, mentor, and develop a team of Supervisors, Operators and Manufacturing Engineers.
• Conduct regular performance reviews and ensure appropriate training and career development.
• Promote a culture of collaboration, ownership, and continuous learning.

Technology Transfer and Process Implementation

• Partner with Global Process Development, MSAT and ENG to ensure effective technology transfer and process start-up.
• Support the introduction of new bioreactor technologies, automation, and process improvements.
• Represent Manufacturing in discussions on process design, scale-up, and validation.

Quality and Compliance

• Ensure adherence to all cGMP and site quality requirements.
• Review and approve batch documentation, deviations, and investigations.
• Participate in regulatory inspections and customer audits.

Safety and Continuous Improvement

• Foster a strong safety culture and ensure compliance with EH&S standards.
• Identify and implement improvement opportunities to enhance throughput and reduce variability.
• Lead and support Lean initiatives and digital transformation projects within the department.

5. Authorities

• Make operational decisions to ensure product quality, safety, and delivery targets.
• Approve production documentation and training records.
• Halt production or raise issues when quality or safety is at risk.

6. Complexity of the Job

This position operates in a complex, multi-product biomanufacturing environment where processes vary between clients and projects. Decisions can have significant technical and financial impact, requiring strong judgment, process knowledge, and leadership.

The Upstream Manager must balance product quality, delivery timelines, and continuous improvement in a regulated, high-value setting.

7. Knowledge and Education

• Bachelor’s in Biotechnology, Biochemistry, Microbiology, or a related field.
• Solid knowledge of mammalian cell culture processes and single-use bioreactor systems.
• Extensive knowledge of current good manufacturing practices, environmental health and safety standards, and biomanufacturing standard methodologies.
• Green Belt certification (Lean Six Sigma) required.
• Desirable: Certifications in Operational Excellence or other continuous improvement methodologies.
• Fluent in English (written and verbal)

8. Experience

• Minimum 5 years of operational experience in a (bio)pharmaceutical manufacturing environment.
• At least 3 years of leadership experience within an operations environment.
• Proven experience with technology transfer, process troubleshooting
• Experienced in Lean and Six Sigma methodologies—including DMAIC, Kaizen, and Value Stream Mapping (VSM)
• Experience supporting audits, Deviations, CAPAs, and inspection readiness.

9. Key Competencies

• Leadership and coaching ability
• Excellent communication and interpersonal skills
• Analytical and structured problem-solving skills
• Proactive and hands-on approach
• Focus on quality, safety, and operational excellence
• Drive for continuous improvement and team development