Group Leader - Cell and Gene Therapy (GMP) jobs in United States
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Thermo Fisher Scientific · 18 hours ago

Group Leader - Cell and Gene Therapy (GMP)

Thermo Fisher Scientific is a global leader in serving science, dedicated to enabling customers to make the world healthier, cleaner, and safer. The Group Leader for Cell and Gene Therapy will manage laboratory activities, oversee operations, and ensure quality and compliance in laboratory work.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
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H1B Sponsor Likelynote

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

Qualification

GMP experienceLeadership skillsTechnical writingPCRSanger SequencingNext Gen SequencingRoot cause analysisAnalytical methods optimizationProject managementMentoringCommunication skills

Required

Bachelors 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
Able to lift 40 lbs. without assistance
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
Able to work upright and stationary and/or standing for typical working hours
Able to lift and move objects up to 25 pounds
Able to work in non-traditional work environments
Able to use and learn standard office equipment and technology with proficiency
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
Must be legally authorized to work in the United States
Must be able to pass a comprehensive background check, which includes a drug screening

Preferred

Prior experience with PCR, Sanger Sequencing, and Next Gen Sequencing
Prior GMP experience

Company

Thermo Fisher Scientific

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Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.

H1B Sponsorship

Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)

Funding

Current Stage
Public Company
Total Funding
$15.97B
Key Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B

Leadership Team

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Stephen Williamson
Senior Vice President and Chief Financial Officer
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Daniella Cramp
Senior Vice President and President, Bioproduction Group
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Company data provided by crunchbase