Director, Formulation Development

Company Overview

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. We cultivate an inclusive culture where everyone feels valued, respected, and empowered, welcoming candidates from all backgrounds to foster a strong sense of belonging.

The Director, 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 role includes accountability for ensuring the timely and successful development and manufacture of phase-appropriate formulations, drug product process scale up, technical transfers, and planning of manufacturing-related activities, and serving as the primary liaison between the formulation team, other departments, external service providers, and contract manufacturers on formulation related issues.

The incumbent may have direct reports and authors and reviews technical documents for regulatory submissions, ensuring adherence to regulatory requirements and SOPs.

• Collaborate with PTC's cross‑functional working groups and play a lead role in addressing formulation needs for preclinical and clinical studies, establishing the strategy and development plan for preformulation, formulation, and process development activities.
• Establish 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.
• Direct and provide technical guidance and oversee formulation activities to support drug discovery and clinical programs, provide develop ability input in the selection of drug candidates, and troubleshoot formulation and process related issues for drug products.
• Evaluate third party service providers for formulation development, and cooperate with Business Development, Legal and Quality to facilitate the execution of service agreements.
• Serve as the primary liaison with formulation development and contract manufacturing sites and with internal and external Quality Assurance groups for assigned projects.
• Collaborate with CMOs and other outsourced partners to transfer manufacturing processes for drug product and monitor cGMP batch manufacture.
• Work with the Clinical Supplies group to plan manufacturing campaigns for drug product.
• May manage, coach and mentor direct reports.
• Perform other tasks and assignments as needed and specified by management.

• PhD degree in a relevant scientific discipline and a minimum of 8 years progressively responsible experience in a pharmaceutical, biotechnology or related environment, OR a Master's degree in a relevant scientific discipline and a minimum of 10 years progressively responsible experience in a pharmaceutical, biotechnology or related environment.
• Strong understanding of physical pharmacy, biopharmaceutics, drug delivery technologies and experience in formulation development of small molecules including oral dosage forms.
• Demonstrated expertise in oral dosage form (tablet, capsule, solution) manufacturing and scale up.
• Demonstrated knowledge of cGMP.
• Proven problem‑solving skills.
• Demonstrated ability to develop and deliver presentations to senior management on current status of projects and at internal and external technical meetings on formulation related technologies and trends.
• Ability to influence without authority.