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.
Job Tags
Monday to Friday, Flexible hours, Day shift,