Technical Services Manufacturing Scientist (tsms) Associate - Pilot Scale

Technical Services & Manufacturing Science (TSMS) Associate - Pilot Scale

The Technical Services & Manufacturing Science (TSMS) Associate is responsible for providing operational and technical support for commercial and pilot laboratory 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.

Your 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.
• Assist in implementing changes through the change control system (e.g., BOM updates, process changes).

What You Need to Succeed (minimum qualifications):

• Bachelor's degree or equivalent in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
• 0 - 2 years' experience in the Biotech/Pharmaceutical industry.
• Familiarity with tools such as JMP or Excel for data analysis is a plus.
• Ability to work in a team environment and support manufacturing activities on the production floor, including occasional off-shift or weekend support if required.
• Detailed understanding of biopharmaceutical production processes and technologies with working knowledge of cGMP standards and experience working in a regulated environment.

What will give you a competitive edge (preferred qualifications):

• MSc in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
• 3+ years' experience in the Biotech/Pharmaceutical industry.
• Demonstrated experience in commercial monoclonal antibody/recombinant protein manufacturing processes.
• Experience in tech transfer, scale-up, and validation of biopharmaceutical processes.
• Experience in capital project design, development, validation, and execution.
• Experience with electronic quality systems (e.g., Veeva QMS, TrackWise) and MES platforms.

Additional Information:

• Location: Elwood, Kansas
• Day shift position. Weekend and evening work is not usual, although it may be required to provide process support to ongoing operations.
• Minimal travel requirements < 10%.

Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

Elanco Benefits and Perks:

• Multiple relocation packages
• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Flexible work arrangements
• Up to 6% 401K matching

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.