Senior Research Fellow, Formulation Development

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 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.

Visit our website to learn more about our company and culture! Site: www.ptcbio.com

Job Description Summary:

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.

Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

• 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 developability input in the selection of drug candidates, troubleshoots formulation & process related issues for drug products.
• Evaluates third party service providers for formulation development and provides input towards their selection as necessary. Collaborates with Business Development, Legal and Quality and facilitates the execution of service agreements. Serves as the primary liaison with formulation development and contract manufacturing sites and with internal and external Quality Assurance groups for assigned projects.
• Collaborates with CMOs and other outsourced partners to transfer manufacturing processes for drug product and to monitor cGMP batch manufacture.
• Works with Clinical Supplies group to plan manufacturing campaigns for drug product.
• May manage, coach and mentor direct reports.
• Performs other tasks and assignments as needed and specified by management.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

• Minimum level of education and years of relevant work experience.

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 respo