- Experience Level
- Experienced (non-manager)
MSAT Engineer III/ Senior Engineer | Durham, North Carolina
The MSAT Engineer 3 will support upstream cell expansion (2D) processes with limited supervision and guidance. This role will collaborate effectively with personnel in Process Development, Manufacturing, Engineering, Quality Assurance, and Quality Control and utilize strong communication, technical expertise and influencing skills to generate optimal results. The role will be the primary cell expansion SME supporting manufacturing and represent MSAT in project teams and troubleshooting activities.
- Provide oversight and accountability for technology transfer and process validation of products into commercial manufacturing facility
- Collaborate with personnel in Process Development, Manufacturing, Engineering, Quality Assurance and Quality Control on process improvement. Provide leadership in developing process improvement priorities
- Process expert on the upstream cell expansion, single use bioreactor control and optimization. Experienced with cGMP cell banking. Mentor junior staff in developing process knowledge and expertise
- Provides advanced level support execution and development of the the company’s upstream cell expansion process (referred to as 2D) other functions as needed. In-depth experience with process automation/DCS and the use of a data historian strongly preferred
- Maintain and report process run summaries and continued process verification reports
- Prepare and present data associated with manufacturing processes
- Maintenance of Process Control Strategy
- Collaboratively supports troubleshooting, non-conformance investigation, and change control management activities utilizing advanced engineering concepts and data analytics/trending
- Identify continuous improvement opportunities in terms of cost savings, process robustness, and manufacturing efficiency gains. Serve as the key project designee responsible for identifying new technologies set to improve manufacturing capabilities
- Other duties, as assigned
Specific Skill Requirements
· Experience in the development of manufacturing documentation and in the investigation of complex manufacturing deviations
· Able to lead development of solutions and implementation of process improvements to manufacturing issues by way of corrective and preventative actions (CAPAs)
- Ability to coordinate multi-departmental tasks and deliverables (interaction with Process Development, Engineering, QA, QC, etc.).
- Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high-quality processes and end products.
- Ability to provide technical training to others on GMP manufacturing operations.
- Advanced technical understanding of cell and tissue-based products; strong understanding of cGMP manufacturing and US/EU regulations.
- Demonstrated expertise with operation, control and optimization of single use bioreactors. Experience with scale-up/scale-out of bioreactor-based processes.
- Possess exceptional analytical problem-solving skills, including the ability to drive the resolution of complex issues where analysis of events or data requires an in-depth knowledge of process and equipment performance
- Understand and interpret all types of complex data analysis such as multiple linear regression analysis, ANOVA, multivariate analysis and identify applications where appropriate.
Other Skill Requirements
- BS in Biochemistry, Chemistry, Biology or other relevant discipline required; MS in related discipline preferred
- Highly motivated and organized
- Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, cell therapy, tissue engineering, regenerative medicine, process development
- 5-8 years of relevant pharma or biotech industry experience, minimum 5 years GMP experience
- Possess a demonstrated technical foundation of cell- and tissue- based products and proficiency with GMP manufacturing
- Demonstrated ability to build effective working relationships across departments (QA, Process Development, Project Management and Business Development) to support new processes and products
- Experience leading projects related to bioprocessing deviations, change control, process optimization, technical troubleshooting, and bioprocessing process changes
- Experience with cell culture and upstream bioprocessing, experience with adherent mammalian cells preferred
- Strong scientific and technical experience performing upstream bioprocessing activities involving seed train, media optimization, cell line development/banking, and experience with automated single use bioprocessing systems