Lead Process Engineer - Downstream - MS&T
About the Job
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
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.
Location/Division Specific Information
How will you make an impact?
The MST Downstream Lead Scientist/Process Engineer 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 cross-functional departments throughout the organization.
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.
How will you get here?
- BS - biochemical engineering, chemical engineering or related scientific discipline such as molecular biology, virology, biochemistry – required. Advanced degree preferred.
- 3+ years 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.
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.