Sr. Principal Process Engineer - Oligonucleotides
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Upload Your ResumeAbout This Role
Provide technical leadership for production operations in small molecule or peptide manufacturing, focusing on oligonucleotide API supply. Mentor process engineers, optimize processes, and manage equipment qualification.
Responsibilities
- Mentor process engineers in core engineering practices for oligonucleotide API supply
- Promote data-driven decision-making using statistical methods and first principles
- Support and review root cause analyses and technical documentation
- Identify and address process knowledge gaps affecting equipment and process performance
- Capture key process knowledge such as material and energy balances, kinetics, and design basis
- Maintain process safety foundations and support hazard reviews
- Ensure equipment qualification aligns with intended use and remains valid after changes or maintenance
- Integrate modeling and simulation to enhance process understanding and control
- Drive continuous improvement in equipment and processes as part of cross-functional teams
- Lead or support tech transfer of new processes and unit operations
- Oversee development of user requirements, design reviews, and verification plans
- Guide return-to-service protocols following equipment interventions
Requirements
- Bachelor's Degree in Process, Chemical, Biochemical Engineering or related applicable STEM discipline
- 5+ years of experience in API Manufacturing Unit Operations
Qualifications
- Bachelor's Degree in Process, Chemical, Biochemical Engineering or related applicable STEM discipline
- 5+ years of experience in API Manufacturing Unit Operations
Nice to Have
- Experience with API chemical synthesis, biotech operations, and chromatography
- Familiar with GMP production environments
- Strong foundation in chemical engineering and technical problem-solving
- Skilled in coaching and mentoring for technical development
Benefits
About BioSpace
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, specializing in discovering and bringing life-changing medicines to patients worldwide. They are investing over $1 billion to create a new state-of-the-art manufacturing site in Concord, NC, focusing on parenteral medication...