Sr. Principal - Engineer - Process (Small Molecule)

Role Summary

The Senior Principal Process Engineer provides technical leadership for production operations in small molecule or peptide manufacturing. Key responsibilities include mentoring process engineers, sustaining process knowledge, supporting equipment and process optimization, and managing engineering systems and assets. During the project delivery and startup phase, the role will be dynamic and collaborative—focused on building the organization, implementing GMP‑supporting systems and processes, and shaping site culture to support full-scale manufacturing.

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 essential process knowledge (e.g., material/energy balances, kinetics, design basis)
• Maintain and support process safety foundations and hazard review activities
• Ensure equipment qualification aligns with intended use and remains valid after changes or maintenance
• Integrate modeling and simulation to improve 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
• Guide development of user requirements, design reviews, and verification plans
• Advise on return-to-service protocols following equipment interventions

Qualifications

• Required: Bachelor's Degree in Process, Chemical, Biochemical Engineering or related applicable STEM discipline
• Required: 5+ years of experience in API Manufacturing Unit Operations
• Preferred: Experience with API chemical synthesis and biotech unit operations, including chromatography
• Preferred: Understanding of GMP production environments
• Preferred: Strong technical foundation in Chemical Engineering
• Preferred: Skilled in analytical thinking and problem-solving
• Preferred: Able to work independently and collaboratively within cross-functional teams
• Preferred: Capable of coaching others to build technical expertise
• Preferred: Creative in identifying improvements and proactive in driving implementation
• Preferred: Experienced in mentoring through technical processes
• Preferred: Flexible and adaptable to meet evolving business needs

Skills

• Strong technical foundation in Chemical Engineering
• Analytical thinking and problem-solving
• Ability to work independently and in cross-functional teams
• Mentoring and coaching capabilities
• Data-driven decision-making, statistics, and first-principles thinking
• Modeling and simulation to improve process understanding and control
• Process safety foundations and hazard analysis
• Equipment qualification and validation experience
• Tech transfer and process development experience
• Ability to develop user requirements, design reviews, and verification plans

Education

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