Sr. Principal Process Engineer - Oligonucleotides

Role Summary

Sr. Principal Process Engineer - Oligonucleotides: Technical leadership for production operations in oligonucleotide API manufacturing, mentoring engineers, sustaining process knowledge, and guiding process and equipment optimization within a startup GMP environment.

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

• Bachelor's Degree in Process, Chemical, Biochemical Engineering or related applicable STEM discipline
• 5+ years of experience in API Manufacturing Unit Operations

Additional Requirements

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