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Thermo Fisher Scientific Scientist II / Engineer II MS&T, Upstream in Lexington, Massachusetts

Thermo Fisher Scientific-Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.

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

The Scientist II / Engineer II Manufacturing Sciences & Technology, Upstream will report into the Sr. Manager MST, Lexington. This position is located in Lexington, MA supporting the Viral Vector Service group.

How will you make an impact?

The MST Scientist II / Engineer II will be responsible for Manufacturing Sciences and Technology activities in support of upstream process technology transfer, late stage clinical, PPQ and commercial manufacturing of viral vectors. The individual will work independently, providing expertise and direction in upstream processing. This position requires close interaction with MS&T colleagues, Project Management, Manufacturing, Quality Assurance, Quality Control, Process Sciences, Process Development, Engineering, Supply Chain and other departments. This role will focus on aspects of implementing and profiling robust, scalable and efficient manufacturing processes to produce late-phase human clinical trial and commercial gene transfer vector products.

What will you do?

  • Participate in and provide leadership to technology transfer teams for cGMP manufacturing of viral vectors.

  • Collaborate with other sites or clients to ensure success of process transfer and scale up.

  • Ensure effective information flow, risk assessment, timeline execution, issue resolution and documentation for cross-functional teams.

  • Includes authoring detailed process definition and facility fit assessment exercises.

  • Represent MST on client programs as assigned

  • Execute process establishment runs and small-scale experiments, ensuring the materials, strategy and documentation are in place.

  • Execute scale down model of manufacturing processes. Maintains a good laboratory practice.

  • Lead investigations of root causes of deviations for cGMP manufacturing, and implement CAPA for major deviations

  • Identifying opportunities to improve systems and practices

  • Author and maintain process risk assessment documents

  • Author protocols and reports and execute studies.

  • Support engineering teams on equipment selection, qualification, and start up activities.

  • Develop sampling plans with clients and incorporate them into cGMP batch documentation.

  • Monitor and trend process performance, including input and output parameters.

  • Work with counterparts in Process Development Process Sciences, Manufacturing, Quality, Project Management teams etc. to facilitate technology transfer and project success.

How will you get here?

Education

A degree in biochemical engineering, chemical engineering or related scientific discipline such as molecular biology, virology, biochemistry. B.S. or Master's degree with 3+ years, or PhD with 1+ years of relevant experience.

Experience

Demonstrated manufacturing technical support experience in a Viral Vector, Biologics, or vaccine production

Knowledge, Skills, Abilities

  • Technical expertise in upstream biopharmaceutical manufacturing and/or process development.

  • Experience with adherent and suspension cell culture techniques, fixed bed and suspension bioreactors.

  • Expertise in late stage/commercial technology transfer, process characterization and process validation biopharmaceutical/gene transfer vector manufacturing preferred.

  • Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing.

  • Knowledge of cell and gene therapy vector production highly desirable.

  • Ability to work both independently and as part of a team.

  • Ability to function in a fast-paced dynamic team environment and balance prioritize multiple projects

  • Project management skills desirable

  • Laboratory skills and the ability to be hands-on.

  • Excellent troubleshooting skills and ability to solve complex technical issues. Ability to compile, analyze and interpret data; Ability to write routine reports and correspondence

  • Strong interpersonal and communication skills, verbal and written.

  • Ability to speak effectively before groups of customers.

  • Ability to communicate in a dynamic environment

At Thermo Fisher Scientific, each one of our 70,000 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.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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