Lead Scientist, Downstream - MST
About the Job
Job Title: Lead Scientist / Process Engineer, Downstream - MST, Lexington
Requisition ID: 128814BR
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 Lead Scientist will be responsible for implementation of robust, scalable and efficient manufacturing processes through leading technology transfer, Process Validation, late stage clinical and commercial manufacturing technical support activities. The individual will provide technical expertise and leadership and requires close collaboration with throughout the organization and is responsible for s.
What will you do?
- Lead technology transfer for cGMP manufacturing of viral vectors.
- 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 cross-functional teams.
- Includes authoring detailed process definition and facility fit assessment exercises.
- MST process lead for Downstream process, ensuring the materials, strategy and documentation are in place.
- Collaborate with PS/PD/QC/QA to develop testing strategy for raw materials and process intermediates.
- Execute process establishment runs and small-scale experiments, ensuring the materials, strategy and documentation are in place.
- Execute scale down model of manufacturing processes. Maintains a good laboratory practice.
- Author and maintain process control strategy documents throughout the lifecycle of a program
- Author and maintain process risk assessment documents
- Author PPQ protocols and reports. Oversee execution of PPQ and PPQ related activities
- Support engineering teams on equipment selection, qualification, and start up activities.
- Develop sampling plans with clients and incorporate them into cGMP batch documentation.
- Monitor and trend process performance, including input and output parameters.
- Investigate root causes of major deviations for cGMP manufacturing, and implement CAPA for major deviations
- Identifying opportunities to improve systems and practices
- Work with counterparts in Process Development, Process Sciences, Manufacturing, Quality, Project Management teams etc. to facilitate technology transfer and project success.
- A degree in biochemical engineering, chemical engineering or related scientific discipline such as molecular biology, virology, biochemistry. Advanced degree preferred.
- B.S. with 8+ years, Master’s degree with 6+ years’ experience, or PhD with 3+ years’ experience.
- Technical expertise in downstream biopharmaceutical manufacturing and/or process development.
- Experience 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 late stage/commercial technology transfer, process characterization and process validation
Knowledge, Skills, Abilities
- Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing.
- Knowledge of cell and gene therapy vector production highly 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
- Project management skills desirable
- Laboratory skills and the ability to be hands-on.
- Ability to speak effectively before groups of customers.
- Excellent 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.