Technical Services Manufacturing Scientist (TSMS) Associate- Pilot Scale

Role Summary

Technical Services & Manufacturing Science (TSMS) Associate - Pilot Scale. Provides operational and technical support for commercial and pilot laboratory operations at the Elwood, Kansas mAb manufacturing facility. Subject matter expert in mAb products and processes; involved in tech transfer, scale-up, process optimization, validation, monitoring, troubleshooting, and continuous improvement activities.

Responsibilities

• Support the execution and troubleshooting of upstream and/or downstream manufacturing processes for biologics (e.g., mammalian cell culture, purification).
• Collaborate with Manufacturing, Development, and Quality teams in the execution of technical/development studies, investigations, validation activities, and technical transfer programs; identify risks, variability sources, improvements, and value engineering opportunities to maximize project return and likelihood of technical success.
• Provide on-floor support during manufacturing campaigns, including troubleshooting and deviation investigations.
• Use scientific and statistical analysis tools to improve process understanding, ensure processes are capable and in control, and identify opportunities for process improvements.
• Author and review technical documents, including batch records, SOPs, PFDs, risk assessments, investigations, technical studies, commissioning and qualification protocols, and reports.
• Assist in implementing changes through the change control system (e.g., BOM updates, process changes).

Qualifications

• Education: Bachelor‚Äôs degree or equivalent in Bio/Pharmaceutical Technology, Microbiology, Engineering, or related discipline.
• Experience: 0‚Äì2 years in Biotech/Pharmaceutical industry.
• Familiarity with tools such as JMP or Excel for data analysis is a plus.
• Ability to work in a team environment and support manufacturing activities on the production floor, including occasional off-shift or weekend support if required.
• Detailed understanding of biopharmaceutical production processes and technologies with working knowledge of cGMP standards and experience in a regulated environment.

Skills

• Technical transfer, scale-up, validation of biopharmaceutical processes
• On-floor manufacturing support and deviation investigations
• Process optimization and continuous improvement
• Documentation and data analysis

Education

• Bachelor‚Äôs degree in Bio/Pharmaceutical Technology, Microbiology, Engineering, or related discipline
• Preferred: MSc in related discipline

Additional Requirements

• Location: Elwood, Kansas
• Day shift; occasional weekend/work may be required to support operations