Process Development Scientist|
Process Development Scientist Job Description
Location/Division Specific Information
How will you make an impact?
Thermo Fisher Scientific is making a significant investment in the dynamic and rapidly growing Cell Therapy space. The candidate will be a part of a Cell Therapy Process Development team and will be responsible for highly specialized technical research and expert consultation including identifying, innovating and designing solutions for unique process development and manufacturing activities related to clinical materials. This position entails a deep understanding of current Good Manufacturing Practice (cGMP) manufacturing requirements and transitioning workflows from Process Development lab to GMP suite. These functions may include but are not limited to activities such as processing of blood related products, isolation and propagation of variety of human primary cells, preparation of cell culture media, culture and expansion of cells in closed automated systems.
What will you do?
· Lead development activities for new processes and procedures for first-in human clinical materials including design of process scale-up/scale-out, use of automation and closed systems (handling of bags and tubing, working with instruments such Sepax C-Pro, Elutra, Xuri, Wave, Lovo, Prodigy etc).
· Design and lead technology transfer activities for customer’s manufacturing process, conduct process development and/or process optimization activities in partnership with customer’s team.
· Design and lead technology transfer activities and conduct process development/optimization with internal Thermo teams for new platforms, technologies and assay development activities
· Design and lead (along with Operation Team) development/establishment runs to meet GMP requirements through successful process transfer.
· Work with internal MS&T partner to conduct thorough gap analysis and risks associated with customer’s manufacturing process and develop documents and plans to clearly communicate such gaps. Develop a strategy to overcome such gaps through process optimization activities.
· Host customers in order to showcase existing manufacturing platforms and discuss ideas for development of new platforms and workflows.
· Authoring and execution of work instructions and/or SOPs, with minimal instruction on a day-to-day basis and a focus on proactive ‘right the first time’ executions.
· Train and support other members of the Process Development Team.
· Able to build and foster strong relationships with cross-functional teams within the Cell Therapy BU including Operations, Quality Control, Quality Assurance, Facilities & Engineering and Environmental Health and Safety.
·Able to build strong relationships with customer liaisons
· Act as On-The-Job-Trainer for a variety of job functions
· Able to execute all Department functions, such as maintaining suite, supplies, equipment, logbooks and data in accordance with site SOPs and policies.
· Able to travel to internal Thermo sites for training and customer sites for Technology Transfer activities. Travel up to 20%
How will you get here?
· Bachelor’s degree in science or engineering required. Master’s degree in science or engineering preferred.
· 5-8 years of relevant experience in a related field or industry required
· Experience in GMP environment preferred
Knowledge, Skills, Abilities
· Understanding ‘why’ and not just the ‘how’ of processes and practices
· Knowledge of cGMP practices required
· Knowledge and deep experience of aseptic techniques, cell culture, workflows for manufacturing Cell Therapy products (CAR T, MSCs, iPS cells etc)
· Knowledge and deep experience in cryopreservation and fill & finish activities for final Cell Therapy product required
· Confidence and experience with closed and automated systems specific to Cell Therapy manufacturing required
· Mechanical Skills/ Analytical Skills/Method Automation
· MS Office
· Strong math skills
· Strong prioritization skills
· Extremely detail oriented
· Results driven
· Able to read, write, and communicate in English
· Able to understand and carry out instructions
· Strong communication (written and verbal)
· Effectively multi-task
· Able to work in an environment of change
· Able to work independently and as part of a team
· Able to recognize problems developing, not just occurring