Senior/Principal Scientist - Process Chemistry Senior/Principal Scientist - Process Chemistry Discovery Chemistry & API GMP Kilo-Lab
Location: Exton, PA
Position Summary: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.
Key Responsibilities:- Process Development & Scale-Up
- 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.
- GMP Kilo-Lab Technical Support
- 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.
- Client Interaction & Project Leadership
- 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.
- Documentation & Regulatory
- 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.
- Team & Capability Development
- 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.
Qualifications (Flexible for Senior Scientist Associate Director)
- 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.
Salary and Benefits:Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance
