Group Leader - Cell Based Assays (GMP) 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

Biotechnology, Pharmaceuticals, Clinical ResearchIndustries

Requirements

Bachelor's degree or equivalent
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years) or equivalent and relevant combination of education, training, & experience
1+ year of leadership responsibility
Demonstrated proficiency on technical operating systems
Proven leadership skills
Ability to train and mentor junior staff
Demonstrated ability to be project solution driven
Good written and oral communication skills as well as presentation skills
Can independently perform root cause analysis for method investigations
Technical writing skills; ability to write quality documents (SOPs, investigation forms, etc.)
Demonstrated knowledge of QA metrics of program base; ability to write and recommend changes to PPD SOPs
Ability to independently optimize analytical methods
Project and time leadership skills
Prior experience with (incomplete in description)
Must be legally authorized to work in the United States
Must be able to pass a comprehensive background check, which includes a drug screening

Responsibilities

Provides line-level management coordination of resources and work schedules for laboratory activities
Oversees daily operations and assists in preparation and implementation of company policies, quality systems and training programs
Ensures that projects are completed in a timely manner so that company revenues are met and clients are satisfied with the quality and turnaround time of work being performed
Ensures that laboratory staff continues to be developed to keep pace with department goals and growth
Performs lab work in accordance with client protocols, methods and requirements
Prepares study protocols, project status reports, final study reports and other project-related technical documentation
Designs experimental study and participates in technical troubleshooting
Reviews, interprets and analyzes data for technical quality and compliance to protocols, methods and SOPs
Reviews laboratory investigations and deviation
Organizes, schedules and supervises laboratory resources for group's project activities and updates project status
Responds to client questions and needs, coordinates client communication and records meeting minutes
Assists group leaders in their responsibilities
Assists in preparation and implementation of PPD/client SOPs and company operational policies
Ensures adherence to SOPs, safety standards and company policies

Skills

Key technologies and capabilities for this role

Cell Based AssaysGMPLaboratory ManagementQuality SystemsTraining ProgramsLine ManagementProject Management

Questions & Answers

Common questions about this position

Is this a remote position or onsite?

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

What is the work schedule for this role?

The position is Monday - Friday, 1st shift (days).

Is relocation assistance provided?

Yes, relocation assistance will be provided for this position. We welcome applicants from all locations within the US.

What are the key responsibilities of this role?

The role involves providing line-level management coordination of resources and work schedules, overseeing daily operations, performing lab work per protocols, designing experiments, analyzing data, and ensuring project timelines and quality standards are met.

What qualifications are needed to apply?

Candidates must be legally authorized to work in the United States and able to pass a comprehensive background check, which includes a drug screening.

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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