Sr. Process Engineer/Sr. Scientist

• 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.

• 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.

• 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.

• 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

• 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

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