Senior Process Engineer - Topicals & Liquids (Scale-Up & Transfer)

MedPharm; Durham (NC); On-site; USD 110,000 - 170,000; Full time

Job summary

MedPharm in Durham, NC seeks a Sr. Process Engineer/Senior Scientist to lead late-stage development for topical and liquid oral products. You will scale up processes, transfer tech to CMOs, and support process validation and lifecycle management.

The role requires expertise in semisolid and liquid manufacturing, troubleshooting, and ensuring cGMP compliance across development, QA, regulatory affairs, and manufacturing teams.

Qualifications

• Master’s or Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.
• 6–10+ years of pharmaceutical development and manufacturing experience.
• Hands-on experience with semisolid and liquid dosage forms and related equipment.
• Ability to author and review validation protocols, technical reports, and investigations.
• Strong technical writing, communication, and cross-functional collaboration skills.

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 and review BMRs, process flow diagrams, and transfer documents.
• Plan and document PPQ and commercial process validation activities.
• Provide technical oversight during audits, deviations, CAPAs, and investigations.
• Collaborate with QA, Regulatory, Supply Chain, and Manufacturing teams.

Skills

Technical writing

Cross-functional collaboration

Process scale-up

Technology transfer

cGMP regulatory knowledge

DOE/QbD

Education

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

Tools

Agitators and mixers

Colloid mills

Liquid filling equipment

Job description

MedPharm in Durham, NC seeks a Sr. Process Engineer/Senior Scientist to lead late-stage development for topical and liquid oral products. You will scale up processes, transfer tech to CMOs, and support process validation and lifecycle management.

The role requires expertise in semisolid and liquid manufacturing, troubleshooting, and ensuring cGMP compliance across development, QA, regulatory affairs, and manufacturing teams.