Senior Scientist/Principal Scientist

Senior Scientist / Principal Scientist – Pharmaceutical Product Development

Job Title:Senior Scientist / Principal Scientist – Pharmaceutical Product Development
Department: Product Development & Manufacturing (PD&M)
Location: Exton, Pennsylvania
Reports To: Associate Director, Product Development & Manufacturing
Employment Type: Full-time, onsite

Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. 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 seeking an experienced Senior Scientist / Principal Scientist to lead formulation and process development activities from early development through scale-up, clinical manufacturing, technology transfer, and registration support.

The successful candidate will provide hands-on scientific leadership, manage assigned projects, mentor scientists, and collaborate with Analytical Development, Quality Assurance, Manufacturing, Engineering, and Project Management.

Strong experience developing oral solid dosage forms is required. Experience with semisolid products is highly desirable, while additional experience with sterile injectable and ophthalmic products is considered an advantage. The final position level will depend on the candidate’s qualifications, technical expertise, and leadership experience.

Key Responsibilities

· Lead pre-formulation and formulation development activities, including assessment of API properties, excipient compatibility, formulation screening, and stability.

· Develop and optimize oral solid dosage forms, including immediate-release and modified-release tablets and capsules.

· Design and execute studies involving blending, wet and dry granulation, drying, milling, compression, capsule filling, and coating, as applicable.

· Evaluate formulation and process factors affecting dissolution, content uniformity, manufacturability, and product stability.

· Develop semisolid products, including creams, gels, and ointments, as required by assigned projects.

· Apply Quality by Design (QbD), risk assessment, and Design of Experiments (DoE) to identify critical quality attributes, material attributes, and process parameters.

· Plan and execute laboratory, pilot, and scale-up batches; establish process controls and support transfer to GMP manufacturing.

· Coordinate with Analytical Development on testing strategies, dissolution methods, stability studies, and interpretation of analytical results.

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