Principal Scientist

Frontage Laboratories•Exton, PA

4d•Onsite

About The Position

Frontage Laboratories is expanding its API GMP capabilities to support early- and mid-phase development programs for global biotech, pharmaceutical, and academic partners. We are seeking an experienced Process Chemistry Scientist to lead route scouting, process optimization, scale-up, and GMP batch support for small-molecule APIs. This is a hands-on laboratory role with technical leadership responsibilities and potential advancement to Associate Director, depending on experience.

Requirements

Advanced degree (MS or PhD) in Organic Chemistry, or related field, with significant industry experience in process chemistry, CRO/CDMO, or pharmaceutical development.
Strong hands-on expertise in multi-step organic synthesis, route design, process optimization, impurity control, and scale-up.
Working understanding of kilo-lab or pilot-plant operations and GMP manufacturing support.
Experience with analytical data interpretation and process safety considerations.
Demonstrated ability to effectively communicate with cross-functional teams and external clients.
Proven leadership ability — ranging from mentoring peers (Senior Scientist) to providing strategic program direction (Principal Scientist / Associate Director).
Ability to thrive in a fast-paced CRO environment with multiple concurrent client programs.

Responsibilities

Design, develop, and optimize scalable synthetic routes for small-molecule APIs and intermediates.
Conduct reaction optimization, impurity profiling, and robustness studies.
Execute demonstration/engineering batches and support kilogram-scale manufacturing campaigns.
Contribute to batch record drafting, process descriptions, and execute support kilogram-scale manufacturing campaigns.
Provide on-the-floor technical support during non-GMP and GMP campaigns.
Troubleshoot process deviations and equipment issues in real time.
Collaborate with QA, QC, CMC Operations, EHS, and Engineering.
Serve as the technical point-of-contact for client programs.
Present data clearly, propose development strategies, and manage timelines.
Support CMC planning, risk mitigation, and tech-transfer discussions.
Prepare process development reports, tech-transfer packages, and supporting CMC documentation.
Ensure full compliance with non-GMP & GMP requirements and contribute to IND process sections.
Mentor junior chemists and contribute to building best practices in the new kilo-lab.
Support implementation of SOPs, equipment capabilities, and continuous improvement initiatives.
Participate in hiring and onboarding as the group expands.