
Sr. Reagent Manufacturing Scientist/ Project lead
- Indianapolis, IN
- Permanent
- Full-time
- Lead and execute Sustaining projects across several cross-functional teams composed of multiple internal functions including Product Development, Procurement, Quality, Regulatory, Supply chain and Marketing.
- Ensure manufacturing readiness for New Product Introduction (NPI) projects, ensuring seamless transfer from development to production.
- Collaborate cross-functionally with R&D, Procurement, Quality, and Supply Chain to define requirements for formulation, packaging, and process requirements for NPI projects.
- Support design transfer by translating product requirements into manufacturing workflows, including creation of process documentations such as assembly drawings/Product Master record, work instructions, Bill of Materials (BOMs), and routings for reagent manufacturing.
- Apply technical knowledge to support root-cause analysis, implement corrective actions, and sustainment as part of continuous improvement efforts.
- BS degree in Life Sciences , molecular Biology, biochemistry, bioengineering or closely related discipline with 5+ years’ experience in reagent manufacturing within a regulated industry such as life sciences or medical devices.
- In depth understanding of design controls and best practices for reagent manufacturing.
- Demonstrated ability to organize, prioritize, plan, and execute multiple large-scale projects from definition through implementation, coordinating with cross-functional internal teams and third-party contractors
- Strong problem-solving skills, adaptability to changing priorities, and to deliver results to meet project timelines.
- Familiarity with ERP systems (e.g. Oracle) and willingness to travel up to 10%, as needed, for supplier or inter-site collaboration.