Technical Services & Manufacturing Science; TSMS Scientist - Nights
Listed on 2026-05-22
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Engineering
Validation Engineer, Quality Engineering, Biotechnology, Process Engineer
Your Role:
Technical Services & Manufacturing Science (TSMS) Scientist, Nights
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.
YourResponsibilities:
- 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.
Education: Bachelor’s degree (or equivalent experience) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
Experience: Working knowledge of biopharmaceutical production processes and technologies, along with experience in a cGMP‑regulated environment.
Top 2
Skills:
Strong analytical and problem‑solving capabilities; and the ability to provide technical troubleshooting and collaborate effectively across cross‑functional teams.
- 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.
- Location:
Elwood, Kansas - Shift: Night shift position with weekend and evening rotation to support ongoing operations
- Travel:
Minimal (
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