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Job Title: Manager Analytical Sciences, Cell Therapy
Company Name: Thermo Fisher Scientific
Location: Research Triangle Park, NC
Position Type: Full Time
Post Date: 09/09/2022
Expire Date: 11/27/2022
Job Categories: Biotechnology and Pharmaceutical, Healthcare, Other, Healthcare, Practitioner and Technician, Information Technology, Manufacturing and Production, Science, Purchasing, Executive Management, Quality Control, Research & Development, Medical, Writing/Authoring
Job Description
Manager Analytical Sciences, Cell Therapy

Work Location: San Francisco, CA

  • This position is ONLYavailable at the San Francisco, CA site *This position has been approved for relocation assistance.*
Group: Pharma Services Group
Division: Pharma Services
Business Unit: Advanced Therapies
Organization: Advanced Therapies - Cell Therapy

Thermo Fisher Scientific is making a significant investment in the dynamic and rapidly growing Cell Therapy space. Our Cell Therapy organization within the Pharma Services Group, is one of the fastest growing areas of Thermo Fisher Scientific. That being said, we have begun to build and operate a 44,000-square-foot, state-of-the-art cell therapy collaboration center on the UCSF Mission Bay campus. Expected to open in 2022, the facility will serve as a central location where customers and UCSF researchers will have access to Thermo Fisher Scientific’s broad portfolio of solutions and clinical and commercial cGMP cell therapy manufacturing services, along with associated technology development support to UCSF and other partners. In the Cell Therapy group, we focus on providing development and clinical scale services for gene and non-gene modified cell processing for a variety of unmet medical needs.

How will you make an impact?
You will manage the Cell Therapy Analytical Development (AD) team and will oversee highly specialized technical research to support the development, optimization, qualification and execution of cell-based, nucleic acid-based, protein-based and chemistry-based assays that support quality control of cell therapy products under development and manufacturing. Your experience and understanding of analytical design and development will establish new analytical methods and standard procedures for cell therapy product characterization.

What will you do?
  • Direct a team of people leaders and scientists to driving customer engagement and Cell Therapy Analytical Services revenue through early adoption of disruptive technologies
  • Act as lead on multiple programs and provide guidance to other program managers
  • Investigate, design, and validate new scientific methodologies on highly critical, unique, and complex projects related to cell therapy analytical science
  • Oversee day-to-day AD activities and provide technical guidance to the team to develop, qualify and tech transfer assays to assess identity, purity, safety and potency of cell therapies including but not limited to FLOW cytometry, PCR/ddPCR, ELISAs, and cytotoxicity assays
  • Support the technology transfer of analytical methods to QC and assist QC with analytical method qualification and validation
  • Work closely with the Director of Process Sciences and participate in building a strong AD team, including defining its vision, strategy, execution, hiring, training, staff assignment, coaching, mentoring and performance management
  • Manage all project scopes, resource requirements, project timelines and deliverables and plan/coordinate project work accordingly with departmental, functional and external stakeholders
  • Collaborate with Program Management to ensure clear expectations and successful deliverables.
  • Work with Process Development and Manufacturing groups to trouble-shoot process challenges
  • Oversee recording of results and preparation of protocols, reports, test methods, and SOPs

How will you get here?
  • BS or MS in immunology, cell/molecular biology or related biological sciences; MS preferred; PhD is ideal; Equivalent combinations of education, training, and relevant work experience may be considered
  • 6+ years’ experience related to pharmaceutical manufacturing, process, or analytical development
  • 3+years’ experience leading teams of Scientists
  • Experience working with various cell types (including T cells, NK cells, CAR-T, or Stem Cells) as well as viral or non-viral genetic modification is preferred
  • Experience working in a CDMO is preferred
  • Demonstrated leadership, problem solving and critical thinking skills

Knowledge, Skills, Abilities
  • Advanced and deep knowledge of principles, concepts, and practices in cell therapy
  • Excellent understanding of analytical method development and characterization as it pertains to cell therapy
  • Strong knowledge of GMP regulations as it pertains to best practices in cGMP manufacturing
  • Excellent writing, communication, and presentation skills
  • Ability to travel (up to 10%)

This position has been approved for relocation assistance.

Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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Contact Information
Company Name: Thermo Fisher Scientific
Company Description:

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