Location: Cambridge, MA

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. 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

How will you make an impact?

The Downstream Scientist II of Manufacturing Sciences and Technology (MST) will be responsible for technical manufacturing support in accordance with current good manufacturing practices (cGMP) for VVS Cambridge phase III/commercial manufacturing site. He/she will provide leadership and scientific oversight to the MST downstream team to ensure robust and reliable production processes are established through a rigorous technology transfer process to enable the site to meet and/or exceed client delivery commitments.

What will you do?

• Provide downstream technical leadership to process engineers, scientists, and associates for suspension platform cell cultures of late stage clinical, process validation and commercial stage products including overseeing the design and execution of studies, investigation and data analysis of results, and writing/review of technical reports. Must stay current with relevant technologies and forward thinking to identify new approaches.

• Manage technology transfer from Process Sciences to commercial Manufacturing ensuring effective information flow, timeline execution, issue resolution, training and documentation in accordance with governing tech transfer quality system requirements while leveraging robust risk management practices.

• Oversee process validation and continued process verification and associated documentation, as required

• Manage investigation and data analysis to address deviation and implement change controls

• Provide on-site support during the process validation campaigns and associated documentation and regulatory filings.

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

• Keep current on regulatory and quality requirements and follow Environment, Health & Safety policies.

How will you get here?

The Downstream Scientist II will partner with Process Development, EHS, Quality, Manufacturing, and Process Sciences groups to ensure compliance and collaboration. This position will also interface with external clients, providing expertise and process guidance.

Education

• A degree in biochemical engineering, chemical engineering or related scientific discipline such as molecular biology, virology, biochemistry. PhD preferred.

Experience

• B.S. with 4+ years’ experience, or Master’s degree with 2+ years’ experience, or PhD with 1+ years’ experience.

• Experience with various chromatography resins and membranes.

• Experience with various AKTA systems.

Knowledge, Skills, Abilities

• Technical expertise in downstream biopharmaceutical manufacturing and/or process development. Experience with filtration (dead end and tangential flow) and process considerations for scale up

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

• Knowledge of various platforms for vector production (transient transfection, stable producer cell lines, and helper virus technology) is strongly recommended.

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

• Excellent troubleshooting skills and ability to solve complex technical issues.

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.