Technical Services Manufacturing Scientist (Night Shift)

Elanco•Elwood, KS

4d•Onsite

About The Position

The Technical Services & Manufacturing Science (TS/MS) Scientist is responsible for providing Primary and/or Secondary loop technical support for commercial 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. The TSMS scientist plays a key role in day-to-day operations and delivery of technical projects.

Requirements

Bachelor’s degree (or equivalent experience) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
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.
Proven analytical thinking and problem-solving skills.

Nice To Haves

MSc or PhD in Bio/Pharmaceutical Technology, Microbiology, Engineering or a related discipline.
Demonstrated experience in commercial monoclonal antibody / recombinant protein manufacturing processes.
Experience in tech transfer, scale up, and validation of biopharmaceutical processes.
Experience with SAP, JMP, Veeva Vault, RCI, FMEA and QRM tools.
Working knowledge of USDA and/or EU GMP regulations for veterinary biologics.

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 product and process subject matter expert in Process Teams, project teams and committees.
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, risk assessments, investigations, technical studies, protocols, and reports.