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Job Title: Manager, Process Development
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, Other / General, Science, Purchasing, Executive Management, Quality Control, Research & Development, Medical, Writing/Authoring
Job Description
Manager, Process Development

Work Location: San Francisco, CA

  • This position is ONLYavailable at the San Francisco, CA site *This position has been approved for relocation assistance.*
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 late 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. By working with leaders from other related business units to provide customers with “one-stop” solutions in the cell therapy space, you help advance the integration of Thermo Fisher service offerings.

How will you make an impact?
The Manager Cell Therapy Process Sciences will work closely with the Director of Process Sciences to accelerate the strategic vision and mission of the cell processing sciences business.

What will you do?
  • Manage Process Development teams and all related customer-facing activities including planning project scope, resource requirements and timelines and deliverables and plan/coordinate project work accordingly with departmental, functional and external stakeholders.
  • Conduct and oversee research and process development activities to optimize Thermo Fisher technology (tools, products and platforms) related to manufacturing therapies for clinical trials.
  • Manage day-to-day activities of Thermo Fisher’s Cell Therapy Collaboration Centers by
    • Testing new manufacturing technologies and platforms in partnership with R&D.
    • Showcasing new technologies to Thermo Fisher’s customers through partnerships for early adoption.
  • Collaborate with Program Management to ensure clear expectations and successful deliverables.
  • Set guidelines for recording of results and review documentation created by others on the team.
  • Oversee preparation of protocols, reports, test methods, and SOPs.
  • Maintain and ensure safe laboratory environment and work practices.
  • Work closely with clients for technology transfer activities, and with MS&T and Operations teams to transfer optimized process for clinical manufacturing and play an important role in to trouble-shooting process challenges.
  • Serve as primary contact with clients and provide regular communication of data and status.
  • Lead relevant program team meetings.

How will you get here?
  • BS in biology, chemistry, biochemistry, biomedical engineering, or related technical discipline; MS preferred; PhD is ideal; Equivalent combinations of education, training, and relevant work experience may be considered
  • MS degree w/ 6+ years’ of experience related to cell therapy manufacturing, pharmaceutical manufacturing, process development experience in a CDMO, industry or academic laboratory and 4+ years of relevant industry discipline experience
  • PhD w/ 4+ years of relevant industry discipline experience and managed a team of Scientists
  • Demonstrated leadership, problem solving and critical thinking skills

Knowledge, Skills, Abilities
  • Advanced and deep knowledge of principles, concepts, and practices specific in cell based manufacturing
  • Strong knowledge of general procedures and regulatory issues and impacts on discipline
  • Ability to function in a rapidly changing environment
  • 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 20%)

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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