Scientist III, Manufacturing Sciences

Job DescriptionAs 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 live 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.How you will make an impact?At Viral Vector Services (VVS), a division of Thermo Fisher Scientific, we deliver extraordinary service from process development through commercial supply. We offer the expertise and vital resources to help clients deliver innovative gene therapies. Placed in the forefront of medicine our pioneering Cell and Gene Therapy business enables clients to cure genetic, rare, and otherwise untreatable diseasesThe Process Engineer III is an authority of technical support and execution for late stage clinical and commercial gene therapy manufacturing. From product introduction through process performance qualification, process engineers keep technical work on track and drive process improvements! Success in this role means that patients will receive an entire new generation of lifesaving gene therapy medications!What you will do?

Provide on-the-floor support for downstream manufacturing operations

Design and implement experimental plans and studies based on the defined work

Expertise and ownership of complex process/product impacting investigations

Coordinate data management and analysis

Act as lead for tech transfers and validation readiness

Own control strategies and documentation including protocols and reports

Identify and drive sophisticated Practical Process Improvement projects

How will you get here?Expertise in a fast-paced and highly technical environment at the forefront of gene therapy manufacturing. Driving projects to meet ambitious first-to-market clinical/commercialization timelines while defining standards and driving improvements.Education and experience

B.S. in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field required 3-5 years validated experience

M.S. in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field + 2 years experience

PhD in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field + 1 years experience

Experience in FDA and EMA regulated manufacturing is encouraged with a role in manufacturing operations, engineering, and/or MST being highly valued.

Knowledge, Skills, Abilities

Authority in technical communication to diverse internal and external team members.

Highly developed project management skills including the ability to deliver large technical projects on exacting timelines

Authority in biologics manufacturing or virology including technical topics in upstream and downstream

Direct experience in FDA, EMA oversight including quality records and audits.

Ability to address intricate technical issues and perform in-depth data analysis in a multi-functional team

Standout colleague with ability to build consensus and drive performance with diverse collaborators

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.