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.
- Prepare and review development protocols, technical reports, master batch records, manufacturing instructions, SOPs, and relevant Chemistry, Manufacturing, and Controls (CMC) documentation.
- Support clinical and registration batch manufacturing, process troubleshooting, and qualification or validation activities within the assigned scope.
- Investigate formulation and manufacturing issues and support deviations, root cause analyses, corrective and preventive actions, and change controls.
- Maintain accurate, complete, and timely documentation in accordance with company procedures and good documentation practices.
- Manage project timelines, resource requirements, and technical deliverables; communicate risks and proposed solutions promptly.
- Serve as a technical contact for clients, present development results, and recommend scientifically justified next steps.
- Mentor junior scientists and provide technical training to laboratory and manufacturing personnel.
- Support technical proposals, feasibility assessments, client meetings, and audits.
- Contribute to sterile injectable or ophthalmic development projects where relevant experience is available.
Required Qualifications
- M.S. with 5+ year of experience, or Ph.D. with 3+ years of experience in Pharmaceutics, Pharmaceutical Sciences, Pharmaceutical Technology, Chemistry, Chemical Engineering, or a related discipline.
- Demonstrated pharmaceutical industry experience in oral solid dosage form development, including formulation optimization, process development, and scale-up.
- Hands-on experience with relevant oral solid processing equipment and unit operations.
- Strong understanding of API and excipient properties and their effects on formulation performance, dissolution, and stability.
- Demonstrated ability to independently design experiments, analyze data, troubleshoot technical issues, and document conclusions.
- Experience transferring development processes to GMP manufacturing and supporting batch execution.
- Working knowledge of cGMP, pharmaceutical quality systems, and CMC development requirements.
- Strong technical writing, project management, communication, and collaboration skills.
- Ability to manage multiple projects and perform hands-on laboratory and manufacturing support activities onsite.
SALARY & 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.