Thermo Fisher Scientific Sr. Process Development Scientist - MTS in St. Louis, Missouri

Job Description

Sr. Process Development Scientist, MTS

Requisition ID: 71371BR

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information

St. Louis, MO

How will you make an impact?

This growth role is available in the Manufacturing Technology Services (MTS) at our St. Louis facility.

This position is responsible for being the primary technical support person for manufacturing processes, investigations of the most challenging technical level, and plays a central role in resolving key process developments. This individual will also lead the team of several junior process scientists to complete similar work across all late phase and commercial processes at the facility.

This person has developed a core competency in technology transfer and supporting processes from the GMP scale production during late phase clinical runs through PPQ campaigns, and commercial campaigns, as well as conducting manufacturing process technical investigations and providing technical advisement to technology transfer teams. The individual may provide immediate supervision or assign tasks to a unit or group of employees.

What will you do?

  • Perform all functions associated with process support, e.g. develop process technical understanding, perform gap analysis / FMEA, generate process models, author changes to and review Process Descriptions and Batch Records

  • Author and perform the technical review of deviations and planned deviations, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary reports, perform activities for lot release (assess deviations and process changes). Actively drive improvements for MTS practices and procedures.

  • May provide guidance on process transfer and support activities to junior members of the team.

  • Assess all major deviations including those that impact product quality as well as post lot release deviations that may impact multiple products.

  • Identify potential root causes using a systematic approach. Exhibit expertise in use/application of a variety of problem solving tools e.g. Ishikawa, Kepner-Tregoe (KT), five-whys, etc. Resolve complex problems and leads multidisciplinary teams in developing and implementing solutions.

  • Perform and be able to understand and interpret all types of complex data analysis such as multiple linear regression analysis, ANOVA, multivariate analysis and identify applications where appropriate.

  • Author and review process descriptions, definitive formulations, batch records, raw material listings, change controls independently and author/review/modify the corresponding templates. Demonstrate ability to identify and create new documents that would aid in process transfer or support activities. Identify process changes and assess change controls for impact of process/equipment or procedural changes that can affect both process performance and product quality. Support documentation preparation for regulatory purposes.

  • Represent MTS on project teams and interface with customer technical and Quality representatives. Represent MTS on internal teams (e.g. Deviation and Run Daily Management System meetings).

  • Participate in Customer and Regulatory Audits. Regularly interact with site and global leadership on matters concerning several functional areas and/or customers.

How will you get here?

Education

  • PhD preferred with a minimum of 8 years of relevant experience. Master’s degree plus 10 years of relevant experience and Bachelor’s degree plus 12 years of relevant experience will be considered.

Experience

  • Extensive biotech industry experience in process scale up and commercial scale manufacturing operations. Disposable technology experience preferred.

  • Experience with large scale manufacturing support (mammalian preferred), current Good Manufacturing Practices, and US / EU regulations.

  • (For Upstream Process Personnel) Advanced knowledge of cell biology, cell culture, scale up and mass transfer, bioreactor operation, disc stack centrifugation, filtration and intermediate knowledge of statistical data analysis. In depth knowledge of large scale manufacturing and current Good Manufacturing Practices.

  • (For Downstream Process Personnel) Advanced knowledge of cell biology, protein structure, scale up, chromatography, UF/DF, virus filtration and intermediate knowledge of statistical data analysis. In depth knowledge of large scale manufacturing and current Good Manufacturing Practices.

At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

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.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

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.