Senior Formulation Development Leader

PTC Therapeutics, Inc; Bridgewater Township (NJ); On-site; USD 191,000 - 240,000; Full time

Job summary

PTC Therapeutics, Inc. is seeking a Senior Research Fellow, Formulation Development to lead formulation design, development, and manufacturing for Phase I–III studies.

You will manage internal and external resources, drive tech transfers to CMOs, and coordinate with cross-functional teams across Clinical, Regulatory, and QA to ensure successful development programs. The role requires expertise in physical pharmacy, biopharmaceutics, and oral dosage forms, with scale-up and development of drug

Qualifications

• PhD in a relevant scientific discipline with 8+ years of biotech/pharma experience, or a Master’s with 10+ years.
• Strong understanding of physical pharmacy, biopharmaceutics, and drug delivery technologies.
• Experience in formulation development of small molecules, including oral dosage forms.
• Demonstrated expertise in tablet, capsule, and solution manufacturing and scale-up.
• Knowledge of cGMP and regulatory submissions support.
• Ability to present to senior management and internal/external technical meetings.
• Ability to influence without authority; leadership if managing reports.
• Travel 10-15%.
• Office/laboratory-based position.

Responsibilities

• Develops robust formulations and manufacturing processes for Phase I-III clinical studies and transfers to CMOs.
• Designs studies and conducts risk assessments to ensure quality-by-design during formulation and process development.
• Performs process scale-up and optimization using DoE and modeling; supports tech transfers to commercial sites.
• Troubleshoots formulation and processing challenges; recommends solutions.
• Develops alternate formulations for current products through lifecycle management.
• Leads cross-functional teams and plans development for preformulation, formulation, and process development.
• Directs third-party providers and liaises with QA, regulatory, and BD for service agreements.
• Collaborates with CMOs to transfer manufacturing processes and monitor cGMP batch manufacture.
• Plans manufacturing campaigns with Clinical Supplies.
• May manage and mentor direct reports.
• Performs other tasks as needed.

Job description

PTC Therapeutics, Inc. is seeking a Senior Research Fellow, Formulation Development to lead formulation design, development, and manufacturing for Phase I–III studies.

You will manage internal and external resources, drive tech transfers to CMOs, and coordinate with cross-functional teams across Clinical, Regulatory, and QA to ensure successful development programs. The role requires expertise in physical pharmacy, biopharmaceutics, and oral dosage forms, with scale-up and development of drug