As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

Thermo Fisher Scientific-Viral Vector Services (VVS) is a rapidly growing, multifaceted 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 groundbreaking Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

A day in the Life:

The MST Upstream Associate Scientist will focus on aspects of ensuring a robust, scalable and efficient upstream 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 team members, Project management, Manufacturing, Quality, Engineering, Supply Chain and other multi-functional departments throughout the organization.

• Participate in multi-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 multi-functional teams

• Represent MST for Upstream 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 assignments.

• Implement 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

Keys to Success:

Education

• Bachelor or Advanced Degree in biochemical engineering, chemical engineering or related scientific field such as molecular biology, virology, biochemistry.

• B.S. with 1+ years of experience or Master’s degree.

Experience

• Basic experience with an understanding of large-scale mammalian cell culture production process platforms from vial thaw through production harvest; experience with viral vector gene therapy processes is a plus. Also requires understanding of depth and TFF filtration unit operations as well as applicable upstream analytical methods for both process characterization and cGMP manufacturing process control. Experience with single use (SU) technology at either lab or manufacturing scale is desirable.

• Experience in GMP environment is desirable.

Knowledge, Skills, Abilities

• Knowledge of viral vector production desirable.

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

• Ability to function in a fast-paced diverse team environment with capability to balance and prioritize different projects with direction from supervisor, as needed.

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

• Basic troubleshooting skills and ability to tackle low to mid-level complexity technical issues. Ability to compile, analyze and interpret data; Ability to write routine reports and correspondence.

• Strong interpersonal and communication skills, verbal and written in a dynamic environment.

Our 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. As 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.

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.

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