Sr. Principal Process Engineer - Oligonucleotides

Role Summary

Sr. Principal Process Engineer - Oligonucleotides providing technical leadership for oligonucleotide API production, mentoring process engineers, sustaining process knowledge, and supporting process and equipment optimization. Responsible for equipment qualification and capability, engineering systems oversight, and cross-functional collaboration. During the startup phase (expected 2029–2030), the role focuses on building the organization, implementing GMP-supporting systems and processes, and shaping site culture to enable successful full-scale manufacturing. Location: Indianapolis, Indiana.

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

Qualifications

• Required: 5+ years of experience in API Manufacturing Unit Operations
• Preferred: Experience with API chemical synthesis, biotech operations, and chromatography
• Preferred: Familiar with GMP production environments
• Preferred: Strong foundation in chemical engineering and technical problem-solving
• Preferred: Able to work independently and within cross-functional teams
• Preferred: Skilled in coaching and mentoring for technical development
• Preferred: Proactive in identifying and implementing improvements
• Preferred: Flexible and responsive to evolving business needs

Education

• Bachelor's Degree in Process, Chemical, Biochemical Engineering or related applicable STEM discipline