Technical Services & Manufacturing Science (TSMS) Scientist - Nights

Elanco•Elwood, KS

2d•Onsite

About The Position

The Technical Services & Manufacturing Science (TSMS) Scientist is responsible for providing primary and/or secondary loop technical support for commercial operations at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. This role serves as a subject matter expert for mAb products and processes and is actively engaged in tech transfer, scale-up, process optimization, validation, monitoring, troubleshooting, and continuous improvement initiatives. The TS/MS Scientist plays a critical role in supporting day-to-day operations and delivering technical projects.

Requirements

Bachelor’s degree (or equivalent experience) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
Working knowledge of biopharmaceutical production processes and technologies, along with experience in a cGMP-regulated environment.
Strong analytical and problem-solving capabilities; and the ability to provide technical troubleshooting and collaborate effectively across cross-functional teams.

Nice To Haves

Advanced degree (MSc or PhD) in a related discipline.
3+ years of experience in the biotech or pharmaceutical industry.
Experience with monoclonal antibody or recombinant protein manufacturing processes.
Experience in tech transfer, scale-up, and validation of biopharmaceutical processes.
Familiarity with SAP, JMP, and Veeva Vault systems.
Strong technical writing skills and experience applying tools such as RCI, FMEA, and QRM.
Working knowledge of USDA and/or EU GMP regulations for veterinary biologics.

Responsibilities

Provide technical and on-floor support for the commercialization, manufacture, and lifecycle management of monoclonal antibody products.
Collaborate with R&D, Manufacturing, and Quality teams to execute technical studies, validation activities, and technology transfer programs.
Support manufacturing teams with real-time troubleshooting and participate in investigations, including root cause analysis of deviations, complaints, and OOS/OOE events.
Ensure proper documentation, CAPA development, and resolution within quality systems.
Act as a subject matter expert for product and process within cross-functional teams, projects, and governance forums.
Utilize scientific and statistical tools to improve process understanding, maintain process control, and identify opportunities for optimization and continuous improvement.
Lead and execute projects to address process performance issues and drive measurable improvements.
Support resolution of technical and compliance-related issues, including preparing technical assessments and responses for internal audits and regulatory agencies.