Senior Research Fellow, Formulation Development

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose:
Extending life's moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team , fostering a strong sense of belonging.

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The Senior Research Fellow, Formulation Development is responsible for leading and directing formulation development and clinical supply manufacturing activities that support PTC's drug discovery and clinical development programs.

This involves preclinical and clinical formulation design and selection, preformulation characterization, process development and scale up and managing external service providers for formulation development and manufacturing.

The Senior Research Fellow, Formulation Development manages and/or oversees internal and external resources to address PTC's formulation development and manufacturing requirements and related business needs. This includes accountability for ensuring the timely and successful development and manufacture of phase-appropriate formulations. Additional responsibilities include drug product process scale up, technical transfers and planning of manufacturing-related activities.

The incumbent works cross-functionally and serves as the primary liaison between the Formulation team, other PTC departments, external service providers and contract manufacturers on formulation related issues.

This individual also authors and reviews technical documents included in various regulatory submissions.

She/He may have direct reports.

The Senior Research Fellow, Formulation Development ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

• Develops robust formulations and manufacturing processes for Phase I-III clinical studies and assists in their transfer to Contract Manufacturing Organizations (CMOs).
• Designs studies and conducts risk assessments as per target product profiles to build in quality-by-design (QbD) during formulation and process development.
• Conducts process scale up and optimization studies using various QbD tools including design of experiments (DoE) and other modeling and scale-up tools. Supports formulation and process technology transfers and scale up to commercial manufacturing sites.
• Conducts troubleshooting of formulation & processing related challenges and recommends potential solutions.
• Develops alternate formulations for current commercial products through life cycle management as required.
• Collaborates with PTC's cross-functional working groups and plays a lead role in addressing formulation needs for preclinical and clinical studies and establishing the strategy and development plan for preformulation, formulation, and process development activities. Leverages knowledge of physical pharmacy, biopharmaceutics, formulation and process design, drug delivery technologies where applicable.
• Establishes the formulation strategy and development plan for preformulation and formulation activities for dosage form development in close collaboration with Clinical, Regulatory, Process Chemistry, Analytical, Project Management and other PTC groups. Leverages knowledge of traditional and enabling drug delivery technologies where applicable.
• Directs and provides technical guidance and oversees formulation activities to support drug discovery and clinical programs, provides develop ability input in the selection of drug candidates,…