Job SummaryThe Senior Scientist will lead late-stage development activities for topical and liquid oral pharmaceutical products, including process scale-up, technology transfer, commercial process validation, and manufacturing support. This role requires strong expertise in semisolid and liquid manufacturing processes, process robustness, troubleshooting, and regulatory compliance to support successful commercialization and lifecycle management.
Key Responsibilities- Lead late-stage formulation and process development activities for topical dosage forms (creams, ointments, gels, lotions) and liquid oral products (solutions, suspensions, syrups).
- Design and execute scale-up, process optimization, and process characterization studies for commercial readiness.
- Support technology transfer activities from R&D to pilot and commercial manufacturing sites, including CMOs/CDMOs.
- Develop and review manufacturing process descriptions, batch manufacturing records (BMRs), process flow diagrams, and technical transfer documents.
- Plan, execute, and document Process Performance Qualification (PPQ) and commercial process validation activities.
- Provide technical oversight during exhibit, registration, validation, and commercial batches.
- Troubleshooting issues related to mixing, homogenization, viscosity, phase separation, settling, aeration, filling, and hold time studies.
- Technical support in investigations for deviations, OOS/OOT results, complaints, and CAPAs related to process or product performance.
- Support cleaning validation, equipment qualification, and continued process verification (CPV) activities.
- Collaborate closely with Analytical Development, Quality Assurance, Regulatory Affairs, Supply Chain, and Manufacturing teams.
- Evaluate process data and statistical trends to ensure process consistency and robustness.
- Support regulatory submissions, deficiency responses, audits, and inspections by providing technical documentation and SME support.
- Ensure compliance with cGMP, FDA, EMA, ICH, and internal quality standards.
Required Qualifications- Master's or Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related scientific discipline.
- 6-10+ years of experience in pharmaceutical development and manufacturing, with significant exposure to topical and liquid oral dosage forms.
- Strong hands-on experience with semisolid and liquid manufacturing equipment including:
- Homogenizers
- Vacuum manufacturing vessels
- Agitators and mixers
- Colloid mills
- Liquid filling equipment
- Experience in process scale-up, technology transfer, and commercial process validation.
- Thorough understanding of rheology, emulsion systems, suspension stability, viscosity control, and preservative systems.
- Strong knowledge of cGMP, DOE, QbD principles, process validation lifecycle, and regulatory expectations.
- Experience authoring and reviewing validation protocols, technical reports, and manufacturing investigations.
- Excellent technical writing, communication, and cross-functional collaboration skills.
Preferred Skills- Experience with SUPAC guidelines for semisolid and liquid products.
- Knowledge of preservative efficacy studies, hold time studies, and in-use stability considerations.
- Familiarity with process analytical tools and statistical analysis software.
- Experience supporting FDA/EMA audits and commercial product lifecycle management.
- Exposure to scale-up challenges associated with emulsion and suspension systems.
Technical Expertise Areas- Emulsion and suspension manufacturing
- Viscosity and rheology optimization
- Mixing and homogenization scale-up
- Process validation (PPQ)
- Technology transfer documentation
- Cleaning validation support
- Continued Process Verification (CPV)
- Manufacturing investigations and CAPA
- Commercial manufacturing support
Typical Deliverables- Technology transfer protocols and reports
- PPQ/Process validation protocols and reports
- Manufacturing risk assessments
- Scale-up and process characterization reports
- Batch troubleshooting investigations
- CPV trend analysis reports
- Regulatory submission support documents
- Hold time and mixing studies documentation
