Technical Services Manufacturing Scientist - Downstream

Role Summary

Technical Services Manufacturing Scientist - Downstream

Responsibilities

• Provide technical and on-floor support for the commercialization, manufacture, and life-cycle management of monoclonal antibody products. This includes troubleshooting, participate in product and process related technical investigations and root-cause analyses of process deviations, complaints, and OOS/OOE events.
• Act as the Process Teams product and process subject matter expert for purification processes which may include chromatography, tangential flow filtration, and centrifugation.
• 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.
• Develop / execute projects to address process performance issues and deliver improvement opportunities.
• Author and provide critical review of technical documents including, but not limited to; batch records, SOPs, PFDs, process recipes, risk assessments, investigations, technical studies, protocols, and reports.

Qualifications

• Required: Education: Bachelor‚Äôs degree (or equivalent experience) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
• Required: Experience in the Biotech / Pharmaceutical industry.
• Required: Detailed understanding of biopharmaceutical production processes and technologies. Working knowledge of cGMP standards and experience working in a regulated environment. Proven analytical thinking and problem-solving skills.
• Preferred: MSc or PhD in Bio/Pharmaceutical Technology, Microbiology, Engineering or a related discipline.
• 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 with SAP, JMP, Veeva Vault, RCI, FMEA and QRM tools.
• Preferred: Working knowledge of USDA and/or EU GMP regulations for veterinary biologics.

Skills

• Process knowledge of purification processes (chromatography, tangential flow filtration, centrifugation).
• Analytical thinking and problem-solving; ability to apply scientific and statistical analysis tools.
• Technical writing and document review capabilities for complex manufacturing documents.

Education

• Bachelor‚Äôs degree or equivalent in a related discipline; advanced degree preferred.

Additional Requirements

• Location: Elwood, Kansas.
• Day shift with weekend rotation to provide process support to ongoing operations.