Technical Services & Manufacturing Science; TSMS) Scientist - Nights

Technical Services & Manufacturing Science (TSMS) Scientist, Nights 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 to execute technical studies, validation activities, and technology transfer programs.
• Support real-time troubleshooting; participate in investigations (root cause analysis for deviations, complaints, and OOS/OOE). Ensure proper documentation, CAPA development, and resolution within quality systems.
• Serve as a subject matter expert for product and process in cross-functional teams, projects, and governance forums.
• Use scientific and statistical tools to improve process understanding, maintain process control, and identify optimization/continuous improvement opportunities.
• Lead and execute projects addressing process performance issues and driving measurable improvements.
• Support resolution of technical and compliance-related issues, including preparing technical assessments/responses for internal audits and regulatory agencies.

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

• MSc or PhD in related discipline; 3+ years in biotech/pharma.
• Experience with monoclonal antibody or recombinant protein manufacturing.
• Experience in tech transfer, scale-up, and validation.
• Familiarity with SAP, JMP, Veeva Vault; technical writing.
• Experience applying RCI, FMEA, QRM.
• Knowledge of USDA and/or EU GMP regulations for veterinary biologics.

• Location:
  
  Elwood, Kansas;
  Night shift with weekend/evening rotation;
  Travel: minimal.