Senior Formulation Development Lead, Phase I-III

ptcbio; New Jersey; On-site; USD 150,000 - 190,000; Full time

Job summary

PTC Therapeutics seeks a Senior Research Fellow, Formulation Development to lead formulation design, preclinical and clinical supply manufacturing, and cross-functional collaboration across the organization. You will direct internal and external resources, ensure regulatory compliance, and manage technology transfers associated with phase-appropriate drug products.

The role requires directing development efforts, partnering with CMOs, and providing guidance on developability and product strategy

Qualifications

• PhD degree with extensive pharmaceutical/biotech experience is preferred.
• Master's degree with substantial experience in pharma/biotech will be considered.

Responsibilities

• Develops robust formulations and manufacturing processes for Phase I-III clinical studies and supports transfer to CMOs.
• Designs studies and conducts risk assessments to build in quality-by-design during formulation and process development.
• Conducts process scale up and optimization using DoE and other modeling tools; supports technology transfers to commercial sites.
• Troubleshoots formulation and processing challenges and proposes robust solutions.
• Develops alternate formulations during lifecycle management as required.
• Leads collaborative efforts with cross-functional teams to set strategy for preformulation, formulation, and process development.

Education

PhD in relevant scientific discipline

Master's degree in relevant scientific discipline

Job description

PTC Therapeutics seeks a Senior Research Fellow, Formulation Development to lead formulation design, preclinical and clinical supply manufacturing, and cross-functional collaboration across the organization. You will direct internal and external resources, ensure regulatory compliance, and manage technology transfers associated with phase-appropriate drug products.

The role requires directing development efforts, partnering with CMOs, and providing guidance on developability and product strategy