Lead Scientist in API Process Development
Seeking a seasoned Lead Scientist to oversee the entire lifecycle of API process development within our fast-paced environment. The role involves designing, optimizing and scaling chemical processes for APIs and intermediates from clinical to commercial stages, while mentoring scientists and collaborating with cross-functional teams.
* Design and optimize chemical processes for APIs and intermediates.
* Partner with clients and internal teams to define strategies, timelines and deliverables.
* Implement innovative technologies such as flow chemistry, PAT, automation and crystallization.
* Troubleshoot process issues and perform risk assessments for scale-up and safety.
* Use design of experiments (DoE) and data-driven approaches to optimize critical parameters.
* Drive successful technology transfer into manufacturing.
* Prepare technical documentation and support regulatory submissions.
* Mentor scientists and promote continuous improvement.
Qualifications
* PhD in Organic Chemistry, Chemical Engineering or related field (MSc with strong experience considered).
* 8-12+ years in API process development (preferably in CDMO).
* Proven experience in scale-up, tech transfer and GMP operations.
* Strong knowledge of regulatory expectations (IND, IMPD, NDA, MAA).
* Hands-on experience with flow chemistry, PAT, automation and new technologies.
* 5+ years of team leadership.
Key Skills
* Strong scientific leadership and client-facing communication.
* Expertise in synthetic chemistry or chemical engineering applied to scalable API manufacturing.
* Experience with QbD, risk assessment and data-driven process design.
* Collaborative mindset and ability to deliver in a dynamic, client-driven environment.
Benefits
* Competitive salary and annual bonus.
* Career development opportunities.
* Further education program.
* Pension scheme.
* Private healthcare.