Senior Process Development Engineer

Job Description

Key Responsibilities

• Lead process scale-up from R&D to manufacturing for API chemical synthesis projects.
• Develop and implement scale-up strategies, identifying risks and mitigation plans.
• Serve as a technical mentor for junior engineers, fostering knowledge transfer and team development.
• Support clinical and pilot-scale production activities tied to scale-up.
• Participate in client-facing technical discussions for complex projects.
• Review and contribute to validation documentation, technical reports, and development protocols.
• Collaborate cross-functionally with Chemistry, Manufacturing, Quality, and Validation teams to ensure first-time success in scale-up execution.

Required Qualifications

• Bachelor’s degree in Chemical Engineering or related discipline.
• 8+ years of engineering experience in API or chemical manufacturing.
• Proven expertise in:
• Chemical synthesis–based API manufacturing
• Process development and first-time scale-up
• Experience in CDMO or API manufacturing environments.
• Strong understanding of scale-up risks and troubleshooting.

Preferred Qualifications

• Exposure to commercial validation, equipment commissioning, and cleaning validation.
• Prior experience mentoring junior engineers.
• Interest in future technical leadership or management opportunities.

Soft Skills & Cultural Fit

• Strong judgment and problem-solving ability; knows when to escalate vs. act independently.
• Collaborative and approachable; shares knowledge without ego.
• Adaptable and hands-on; thrives in dynamic environments.
• Comfortable wearing multiple hats and engaging in cross-functional problem-solving.

Work Environment & Schedule

• Monday–Friday, day shift (flexible start/end times).
• On-call support during active scale-up projects (minimal overtime).
• 24/7 manufacturing site with critical operations planned during day shift.