Senior Process Engineer - Topicals & Liquids

MedPharm Ltd; Durham (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

MedPharm Ltd is seeking a Sr. Process Engineer/Senior Scientist to lead late-stage development for topical and liquid oral pharmaceutical products, including process scale-up, tech 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.

Qualifications

• Master’s or Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.
• 6–10+ years in pharmaceutical development and manufacturing with topical and liquid dosage forms.
• Hands-on experience with semisolid and liquid manufacturing equipment.
• Experience with scale-up, technology transfer, and commercial validation.
• Strong knowledge of rheology, stability, and regulatory expectations.
• Experience authoring and reviewing validation protocols, technical reports, and investigations.

Responsibilities

• Lead late-stage formulation and process development for topical and liquid oral products.
• Design and execute scale-up, process optimization, and characterization studies.
• Support technology transfer from R&D to pilot and commercial sites (CMOs/CDMOs).
• Develop manufacturing descriptions, BMRs, PFDs, and transfer documents.
• Plan and document PPQ and commercial process validation activities.
• Provide technical oversight during exhibits, registrations, validations, and commercial batches.
• Troubleshoot mixing, viscosity, and hold-time studies; investigate deviations and CAPAs.
• Support cleaning validation, equipment qualification, and CPV activities.

Skills

Technical writing

Communication

Cross-functional collaboration

Education

Master’s or Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field

Tools

Homogenizers

Vacuum vessels

Agitators

Colloid mills

Liquid filling equipment

Job description

MedPharm Ltd is seeking a Sr. Process Engineer/Senior Scientist to lead late-stage development for topical and liquid oral pharmaceutical products, including process scale-up, tech 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.