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Principal Scientist

Posted 1 day 17 hours ago by Cpl Healthcare

Permanent

Full Time

Other

Leinster, Ireland

Job Description

Principal Scientist - API Process Development (Swords Campus)

About SK pharmteco
Global CDMO specializing in small molecule APIs, with facilities in Korea, US and Ireland. The Swords site has over 60 years of experience in API development, scale up and commercial manufacturing.

Role Summary

Seeking an experienced Principal Scientist to lead API process development within a fast paced CDMO 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 clients and cross functional teams.

Key Responsibilities

Lead end to end API process development (route scouting, optimization, scale up and GMP manufacture).
Partner with clients and internal teams to define strategies, timelines and deliverables.
Implement innovative technologies (flow chemistry, PAT, automation, crystallisation, green chemistry).
Troubleshoot process issues and perform risk assessments for scale up and safety.
Use 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

Education:

PhD in Organic Chemistry, Chemical Engineering or related field (MSc with strong experience considered).

Experience:

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 vibrations, risk assessment and data driven process design.
Collaborative have to deliver in dynamic, client driven environment.

Benefits