Manager Operations USP at Thermo Fisher Scientific

Groningen, Groningen, Netherlands

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, CDMOIndustries

Requirements

Strong technical understanding of mammalian cell culture
Leadership skills to guide a multidisciplinary team in a fast-paced, customer-focused environment
Proactive approach and Green Belt certification to drive process improvements and operational efficiency through Lean and Six Sigma methodologies
Adherence to Good Manufacturing Practices (GMP), cGMP, EH&S, FDA, EMA, ICH, and Thermo Fisher’s Quality Management System

Responsibilities

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

Skills

Key technologies and capabilities for this role

cGMPcell cultureupstream processingbioreactorsmammalian cell culturemonoclonal antibodiesrecombinant proteinsGMPFDAEMAICHsingle-use bioreactorstechnology transfercontinuous improvement

Questions & Answers

Common questions about this position

What is the reporting structure for the Upstream Operations Manager?

The position reports to the Senior Manager, Manufacturing Operations and has direct reports including Supervisors and Technicians in Upstream Processing (USP).

Is this a remote position or does it require on-site work?

This is not a remote position; it requires on-site work in a manufacturing environment at the Thermo Fisher Scientific site in Groningen, adhering to GMP safety standards.

What key skills and certifications are required for this role?

Candidates need strong technical understanding of mammalian cell culture, leadership skills for a multidisciplinary team, and Green Belt certification for Lean and Six Sigma process improvements.

What is the work environment like at the Groningen site?

The environment is fast-paced and customer-focused as a CDMO site producing monoclonal antibodies and recombinant proteins, involving multiple client projects, technology transfers, new process introductions, and continuous improvement initiatives under cGMP conditions.

What makes a strong candidate for the Upstream Operations Manager role?

Strong candidates will have expertise in mammalian cell culture, proven leadership in manufacturing operations, and Green Belt certification to drive Lean and Six Sigma improvements in a cGMP-compliant, client-focused CDMO setting.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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