Group Leader - Biopharmaceutical at Thermo Fisher Scientific

Middleton, Wisconsin, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

NoVisa

Biopharmaceutical, Life SciencesIndustries

Requirements

Bachelor's degree in lab sciences such as biology, biochemistry, immunology, chemistry, molecular biology or similar
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable experience considered)
Legally authorized to work in the United States without sponsorship
Ability to pass a comprehensive background check, including drug screening
Willingness to work fully onsite in Middleton, Wisconsin (Mon-Fri schedule)
Adherence to Good Manufacturing Practices (GMP) Safety Standards and use of PPE (safety glasses, gowning, gloves, lab coat, ear plugs, etc.)

Responsibilities

Provide management and direction to laboratory staff and resources for project activities and needs
Oversee daily operations to monitor quality and project timelines
Assist in preparation and implementation of company policies, quality systems, and training programs
Ensure responsiveness to the customer and overall client satisfaction
Plan and monitor the progress and quality of projects using financial and quality management tools
Prepare, review, and approve study protocols, project status reports, final study reports, and other project-related technical documents
Design experimental studies and participate in technical troubleshooting
Review data for technical quality and compliance to protocols, methods, and SOPs
Review and approve laboratory investigations, deviations, and QA facility and data audits
Lead client and FDA audits
Allocate, schedule, and manage laboratory resources for group's project activities and update project status
Review timesheet reports for billing accuracy
Respond to client's questions and needs; lead client technical meetings
Assist in preparation of proposals by providing project definition
Identify new opportunities within client base and work with business development to pursue opportunities
Coordinate and prioritize project activities with internal functional groups (physical testing, analytical development, microbiology, etc.) and support functions (QA, sample management, etc.)
Assist management in their responsibilities
Prepare and implement PPD SOPs and company operational policies
Ensure adherence to policies and make recommendations to quality system improvements

Skills

Key technologies and capabilities for this role

GMPBiopharmaceuticalLaboratory ManagementPPEGroup LeadershipClinical ResearchQuality Control

Questions & Answers

Common questions about this position

Is this position remote or onsite?

This is a fully onsite role based at our GMP Laboratory in Middleton, WI.

What is the salary range for this Group Leader position?

This information is not specified in the job description.

What are the key responsibilities of the Group Leader?

The role involves providing management and direction to laboratory staff, overseeing daily operations, monitoring quality and project timelines, designing experimental studies, reviewing data for compliance, and leading audits.

What is the work environment like at Thermo Fisher Scientific?

The role is in a GMP Laboratory requiring adherence to Good Manufacturing Practices and Safety Standards, with some degree of PPE including safety glasses, gowning, gloves, lab coat, and ear plugs.

What qualifications are needed to apply for this role?

Candidates must be legally authorized to work in the United States without sponsorship, able to pass a comprehensive background check including drug screening, and willing to relocate at their own expense since relocation assistance is not provided.

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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