Senior/Principal Scientist – Process Chemistry
Discovery Chemistry & API GMP Kilo-Lab
Location: Exton, PA
Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
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
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Skills Required
- Advanced degree (MS or PhD) in Organic Chemistry or related field with significant industry experience in process chemistry, CRO/CDMO, or pharmaceutical development
- 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 supporting kilogram-scale manufacturing campaigns and GMP batch support
- Experience with analytical data interpretation and process safety considerations
- Demonstrated ability to communicate effectively with cross-functional teams and external clients
- Proven leadership ability, mentoring junior chemists and providing program direction
- Ability to work in a fast-paced CRO environment managing multiple concurrent client programs
What We Do
Frontage Laboratories, Inc. is a CRO that provides integrated, science-driven, product development services throughout the drug discovery and development process to enable pharmaceutical and biotechnology companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of molecules through development and file regulatory submissions in the United States, China and other countries.
