Manufacturing Scientist - Pilot Scale, Technical Services Manufacturing Science

Role Summary

The Technical Services & Manufacturing Science (TSMS) Scientist provides technical support for commercial and pilot laboratory operations at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. The role is a subject matter expert in mAb products and processes, engaged in tech transfer, scale-up, process optimization, validation, monitoring, troubleshooting and continuous improvement activities.

Responsibilities

• 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.

Qualifications

• Bachelor‚Äôs degree or equivalent experience in Bio/Pharmaceutical Technology, Microbiology, Engineering or a related discipline.
• 3+ years‚Äô experience in the Biotech / Pharmaceutical industry.
• Detailed understanding of biopharmaceutical production processes and technologies with working knowledge of cGMP standards and experience working in a regulated environment.
• Preferred: MSc or PhD in Bio/Pharmaceutical Technology, Microbiology, Engineering or a related discipline.
• Preferred: 5+ years‚Äô experience in the Biotech / Pharmaceutical industry.
• Preferred: Demonstrated experience in commercial monoclonal antibody / recombinant protein manufacturing processes.
• Preferred: Experience in tech transfer, scale up, and validation of biopharmaceutical processes.
• Preferred: Experience in capital project design, development, validation and execution.

Skills

• Technical transfer, scale-up, process optimization, validation, monitoring, troubleshooting and continuous improvement for biopharmaceutical processes.
• Analytical thinking using scientific and statistical tools.
• Strong documentation and communication skills for technical reports and protocols.

Education

• Bachelor‚Äôs degree required; advanced degree preferred as listed in qualifications.

Additional Requirements

• Day shift position. Weekend and evening work not usual, although may be required to provide process support to ongoing operations.
• Minimal travel requirements.