Technical Services Manufacturing Scientist - Downstream

Role Summary

The Technical Services & Manufacturing Science (TS/MS) Scientist provides primary and/or secondary loop technical support for commercial downstream operations at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. The role is a subject matter expert for mAb products and processes, and is engaged in tech transfer, scale-up, process optimization, validation, monitoring, troubleshooting, and continuous improvement activities. The TS/MS scientist supports day-to-day operations and technical projects.

Responsibilities

• Provide technical and on-floor support for the commercialization, manufacture, and life-cycle management of monoclonal antibody products, including troubleshooting and participating in product- and process-related investigations and root-cause analyses of 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 in a state of control, and identify opportunities for process improvements.
• Develop and execute projects to address process performance issues and deliver improvement opportunities.
• Author and provide critical review of technical documents including batch records, SOPs, PFDs, process recipes, risk assessments, investigations, technical studies, protocols, and reports.

Qualifications

• Required: Education: Bachelor’s 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 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.

Additional Requirements

• Location: Elwood, Kansas.
• Day shift position. Weekend work on a rotation to provide process support to ongoing operations.