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Thermo Fisher Scientific Manager Analytical Sciences, Cell Therapy in San Diego, California

Thermo Fisher Scientific is a dynamic organization that is looking for motivated scientists to develop the highest quality processes, analytics, and products to our clients. Our staff members; are committed to making a difference in our organization, to the cell and gene therapy field, for our client partners and the patients they serve. We seek individuals with proven competencies and strong character to join our organization.

Work Location: Princeton, NJ

  • This position is ONLY available at the Princeton, NJ site * OPEN TO RELOCATION *

Group: Pharma Services Group

Division: Drug Substance

Business Unit: Biologics Business Unit Support

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. In addition to our facility in Princeton, NJ, 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?

The Manager Analytical Sciences, Princeton 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. This position entails experience and understanding of analytical design and development to establish new analytical methods and standard procedures for cell therapy product characterization.

  • 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. Plan and manage significant technical/scientific project activities to execute strategies and provide solutions that meet client needs and expectations through broad expertise.

What will you do?

  • 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.

  • Serve as primary contact with clients and provide regular communication of data and status and lead relevant program team meetings.

  • 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?

  • 6 years’ experience related to pharmaceutical manufacturing, process, or analytical development

  • 3-5 years’ experience leading teams of Scientists

  • Candidate must have good understanding of analytical method development and characterization as it pertains to cell therapy.

Knowledge, Skills, Abilities

  • Advanced and deep knowledge of principles, concepts, and practices in cell therapy

  • 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.

  • Strong knowledge of GMP regulations as it pertains to best practices in cGMP manufacturing.

  • Demonstrated leadership, problem solving and critical thinking skills.

  • 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 .

Apply today! http://jobs.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.

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.