MST Scientist II, Downstream

This job is with Thermo Fisher Scientific, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Work Schedule
Standard (Mon-Fri)  Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Tile: MST Scientist II, Downstream
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.

Lo  cation/Division Specific Information   Reporting to the Plainville, MA site and supporting the Viral Vector Services (VVS), a division of Thermo Fisher Scientific. At VVS, we deliver from process development through commercial supply, offering the expertise and resources vital to help clients deliver innovative gene therapies. We are placed at the forefront of our leading and groundbreaking Cell and Gene Therapy business, enabling clients to cure genetic, rare, and otherwise untreatable diseases.

Discover Impactful Work:
The primary responsibility is to participate in Manufacturing Sciences and Technology activities in support of downstream technology transfer, late stage clinical, PPQ and commercial manufacturing of viral vectors. The individual will serve as a process expert in downstream processing.  This position requires close interaction with MS&T colleagues, Project Management, Manufacturing, Quality Assurance, Quality Control, Process Development, Engineering, Supply Chain, and other departments.  

This role will focus on aspects of implementing manufacturing processes to produce early- and late-phase human clinical trial and commercial gene therapy products.

A Day in the Life:
MST process lead for Downstream technology transfer activities involved in manufacturing viral vectors following cGMP guidelines.

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 multi-departmental teams (Process Development, Manufacturing, Quality, and Project Management).

Includes authoring detailed process definition, detailed gap assessment, run reports, process flow diagrams and other related documents.

Author process validation documents such as FMEA, PCS, PPQ protocols and reports. Oversee execution of PPQ and PPQ related activities

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

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

Find opportunities to improve systems and practices.

Keys to Success:
Education     BS degree in biochemical engineering, chemical engineering or related scientific field such as molecular biology, virology, biochemistry required.

Advanced degree preferred.

Experience      4-5 years of experience in a highly regulated environment is required with a BS degree, or 2 years' experience will be accepted with an advanced degree.

Experience with automated chromatography systems (AKTA) and automated tangential flow filtration (Repligen).

Experience in downstream biopharmaceutical manufacturing and/or process development.

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

Knowledge of GMP and regulatory requirements of…