Job Title: Associate Scientist, Downstream - MST, Lexington

Requisition ID:

Location: Lexington, MA

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. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

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.

How will you make an impact?

The MST Downstream Associate Scientist will focus on aspects of ensuring a robust, scalable and efficient downstream manufacturing processes through technology transfer, Process Validation, late stage clinical and commercial manufacturing technical support activities. The individual will provide technical expertise and requires close collaboration with MST colleagues, Project management, Manufacturing, Quality, Engineering, Supply Chain and other cross functional departments throughout the organization.

What will you do?

• Participate in cross functional technology transfer activities for cGMP Drug Substance manufacturing of viral vectors
  • Support and collaborate with MST colleagues or clients to ensure success of process transfer and scale up
  • Ensure effective information flow, risk assessment, issue resolution and documentation for cross-functional teams
• Represent MST for Downstream processes on client programs as assigned
• Provide on-the floor support as technical SME
• Maintain an accurate schedule/project plan of assigned MST lab work and deliverables.
• Execute scale down model of manufacturing processes. Maintains a good laboratory practice
• Author protocols and reports related to engineering run, GMP run and PPQ runs as assigned
• Monitor and trend process performance, including input and output parameters
• Support investigation root causes of deviations for cGMP manufacturing and perform impact assessments
• Maintain process control strategy documents throughout the lifecycle of a program
• Author and maintain process risk assessment documents
• Identify and implement opportunities to improve systems and practices

• Bachelor or Advanced Degree in biochemical engineering, chemical engineering or related scientific discipline such as molecular biology, virology, biochemistry.
• B.S. with 1+ years of experience or Master’s degree.

• Basic understanding with a variety of at-scale filtration and column purification methods including TFF, Depth and viral filtration, affinity, ion exchange and size exclusion chromatography as well as applicable analytical methods for process characterization.
• Experience in GMP environment is preferred

Knowledge, Skills, Abilities

• Knowledge of cell and gene therapy vector production 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
• Laboratory skills and the ability to be hands-on.
• Ability to speak effectively before groups of customers.
• Basic 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 75,000 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.