Technical Services & Manufacturing Science (TSMS) Scientist

About the role

The Technical Services & Manufacturing Science (TSMS) Scientist at Elanco is responsible for providing operational and technical support for commercial and pilot laboratory operations at the Elwood, Kansas, monoclonal antibody (mAb) manufacturing facility. This position is a subject matter expert with respect to mAb products and processes.

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, and 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.
• Provide on-floor support during manufacturing campaigns, including troubleshooting and deviation investigations.
• 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.
• 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.
• Aid in implementing changes through the change control system (e.g., BOM updates, process changes).

Requirements

• Education: Master's or Bachelor’s degree or equivalent in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
• Experience: 3+ years of experience in the Biotech / Pharmaceutical industry. Must have hands-on experience with chromatography (including Protein A or affinity chromatography), bioreactor operation, and tangential flow filtration (TFF).

Preferred Qualifications

• Advanced degree (MSc) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related field.
• Hands-on experience in commercial manufacturing of monoclonal antibodies and/or recombinant proteins.
• Proven track record in tech transfer, process scale-up, and validation within biopharmaceutical operations.
• Experience with capital project execution and familiarity with electronic quality systems (e.g., Veeva QMS, TrackWise) and MES platforms.