R&D Manager, Cell & Gene Therapy Consumables and Analytics

Job Description
Do you have a passion for innovative ideas and groundbreaking discoveries? With over $1 billion invested annually in R&D, at Thermo Fisher Scientific you'll help solve some of the world's toughest challenges, from giving cancer patients hope, ensuring safe drinking water and helping law enforcement tackle cases through forensics. We empower our teams to put science into meaningful action and give our R&D colleagues the autonomy, resources and tools they need to take science a step beyond.\n*How will you make an impact?

*\nThe Cell and Gene Therapy (CGT) segment within our Cell Biology business is seeking a highly motivated technology savy Senior Scientist/R&D Manager to lead the analytical assay development team for supporting closed automated CGT manufacturing instrument consumables and reagent product development efforts. You will have prior people leadership experience, a strong technical background in analytical chemistry, understand cell and gene therapy (CGT) workflows, and have experience both with instrument consumables and reagent relevant residual assay development. Prior experience working with blood cells and stem cells (e.g., primary T cells, NK cells, iPSCs, HSCs) is a plus.

This role will be working in a matrixed and highly collaborative team environment, often requiring interaction with a global cross functional team. \n \n*What will you do?*\n\n* Lead an R&D team passionate about the development of assays to support characterization and release QC of cell and gene therapy manufacturing related instrument consumables and reagents. \n* Assay development efforts include but not limited to extractables and leachable testing, visible or sub visible particulates assessment, residual assays to evaluate raw material carryover\n* Lead inhouse development and execution of analytical assays such HPLC, LC-MS, FTIR, NMR, imaging and flow cytometry-based assay to support characterization and release assays for gene and cell therapy manufacturing related products\n* Partner with internal and/or external regulatory subject matter experts to assess cleanroom/GMP compliance of closed automated instrument consumables and reagents that are intended for use in cell or gene therapy manufacturing applications.\n* Work with regulatory team during new product development to define testing parameters for design and product specification review\n* Process primary cells including but not limited to T cells, NK cells or Stem cells using closed automated instruments to test media and other reagent compatibility with instrument consumables\n* Oversee some reagent formulation development for viral or non-viral gene delivery and cell processing workflows\n* Prepare regulatory documents and be up to date with GMP and relevant FDA guidelines for cell and gene therapy consumables\n* Design experiments, analyze data and present data to internal stakeholders and external customers as needed\n* Lead a team of 4-5 colleagues and provide ongoing coaching related to performance and development \n* Work closely with internal or external subject matter experts to evaluate new assay automation opportunities and keep up to date with current trends in the field\n \n*Keys to Success: *\n*Education/Experience*\n\n* Master's degree with 7-10 years of experience in analytical chemistry, cell biology, immunology or other relevant disciplines with extensive knowledge in and assay development related to CGT workflows; PhD with 2-5+ years of experience preferred.

\n* 3+ years experience in cell and gene therapy manufacturing related workflows with primary focus on analytics and assay development\n* Minimum 2 years of people management experience with performance management and career development coaching expertise\n* Working experience managing projects requiring usage of analytical platforms like LC-MS, HPLC, FTIR or NMR is required \n* Familiarity with advanced cell or gene therapy platform development, and closed automated cell therapy manufacturing workflows is required \n* Prior experience in cell-based assays or functional characterization of relevant immune cells (T, NK, HSCs and iPSCs ) using multicolor flow cytometry, immunofluorescence assays and cell sorting is preferred.\n \n*Knowledge, Skills, Abilities *\n\n* Fast learner with demonstrated independence in experimental design, data analysis and interpretation, and prior knowledge of JMP software and DOE is highly desired\n* Possess a deep intellectual curiosity\n* Excellent presentation, verbal and written communication skills proven by publications and presentations\n* Ability to work in collaborative and fast paced environment and be flexible and maintain a positive attitude when business priorities shift \n \nOur Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. A one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

#StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.\n \nApply today! http://jobs.thermofisher.com\nThermo 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.\n \nAccessibility/Disability Access\nJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments.

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