Sr. Scientist - Technical Services & Manufacturing Science, M&Q

Elanco•Elwood, KS

3d•Onsite

About The Position

As the Technical Services & Manufacturing Science (TSMS) Sr. Scientist, you’ll provide technical support for commercial and pilot laboratory operations at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. In this role, you’ll serve as a subject matter expert for mAb products and processes, supporting tech transfer, scale-up, process optimization, validation, monitoring, troubleshooting, and continuous improvement activities.

Requirements

Bachelor’s degree or equivalent in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
3+ years of experience in the Biotechnology or Pharmaceutical industry.
Detailed understanding of biopharmaceutical production processes and technologies.
Working knowledge of cGMP standards and experience working in a regulated environment.

Nice To Haves

MSc or PhD in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
5+ years of experience in the Biotechnology or Pharmaceutical industry.
Demonstrated experience with commercial monoclonal antibody or recombinant protein manufacturing processes.
Experience in tech transfer, scale-up, and validation of biopharmaceutical processes.
Experience with capital project design, development, validation, and execution.
Strong scientific and statistical analysis capabilities.
Experience identifying process variability, technical risks, and continuous improvement opportunities.

Responsibilities

Partner with Manufacturing, Development, and Quality teams to execute technical and development studies, investigations, validation activities, and technical transfer programs.
Collaborate with cross-functional teams to identify risks, sources of variability, improvement opportunities, and value engineering opportunities to maximize project return and technical success.
Apply scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes remain capable and in a state of control, and identify opportunities for process improvement.
Participate in the design, development, execution, commissioning, qualification, and validation of major projects.
Support project scope definition, development and analysis of design options, establishment of user requirements, equipment selection, and commissioning and qualification activities.
Design and execute cleaning validation and process validation activities.
Author and provide critical review of technical documentation, including batch records, SOPs, PFDs, risk assessments, investigations, technical studies, and commissioning and qualification protocols and reports.
Support a strong safety, quality, compliance, and continuous improvement culture within the manufacturing organization.