About the position
The Technical Services & Manufacturing Science (TSMS) Scientist is responsible for providing technical support for commercial and pilot laboratory operations at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. The position is a subject matter expert with respect to mAb products and processes and is engaged in tech transfer, scale-up, process optimization, validation, monitoring, troubleshooting and continuous improvement activities. Work with Manufacturing, Development and Quality teams in execution of technical / development studies, investigations, validation activities and technical transfer programs. Collaborate with team members to identify potential risks, sources of variability, improvement, and value engineering opportunities to maximize project return and likelihood of technical success. Use scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes are capable and operating in a state of control, and identify opportunities for process improvements. Participate in design, development, execution, commissioning, qualification, and validation activities for major projects. This includes, but is not limited to; definition of project scope, development and analysis of design options, establishment of user requirements, selection of appropriate equipment, support of commissioning and qualification programs, design and execution of cleaning validation / process validation activities, etc. Author and provide critical review of technical documents including, but not limited to, batch records, SOPs, PFDs, risk assessments, investigations, technical studies, commissioning and qualification protocols and reports.
Responsibilities
- Provide technical support for commercial and pilot laboratory operations at the mAb manufacturing facility.
- Engage in tech transfer, scale-up, process optimization, validation, monitoring, troubleshooting and continuous improvement activities.
- Collaborate with Manufacturing, Development and Quality teams in execution of technical/development studies, investigations, validation activities and technical transfer programs.
- Identify potential risks, sources of variability, improvement, and value engineering opportunities.
- Use scientific and statistical analysis tools to improve process understanding and ensure manufacturing processes are capable.
- Participate in design, development, execution, commissioning, qualification, and validation activities for major projects.
- Author and provide critical review of technical documents including batch records, SOPs, PFDs, risk assessments, investigations, and technical studies.
Requirements
- Bachelor’s degree or equivalent experience in Bio/Pharmaceutical Technology, Microbiology, Engineering or a related discipline.
- 3+ years’ experience in the Biotech / Pharmaceutical industry.
- Detailed understanding of biopharmaceutical production processes and technologies.
- Working knowledge of cGMP standards and experience working in a regulated environment.
Nice-to-haves
- MSc or PhD in Bio/Pharmaceutical Technology, Microbiology, Engineering or a related discipline.
- 5+ years’ experience in the Biotech / Pharmaceutical industry.
- Demonstrated experience in commercial monoclonal antibody / recombinant protein manufacturing processes.
- Experience in tech transfer, scale up, and validation of biopharmaceutical processes.
- Experience in capital project design, development, validation and execution.
