Director of Formulation Development

Pinnacle Medicines; Doylestown (Bucks County); On-site; USD 120,000 - 180,000; Full time

Job summary

An established industry player is on the lookout for a Director of Formulation Development to spearhead innovative peptide projects. This role offers the chance to lead formulation efforts, identify novel solutions, and develop cutting-edge formulations that enhance drug properties. The ideal candidate will have a strong background in pharmaceutical sciences, with a Ph.D. and over seven years of experience in formulation development. Join a dynamic team dedicated to pushing the boundaries of peptide technologies and making significant contributions to the field. If you thrive in a collaborative environment and are eager to drive innovation, this opportunity is perfect for you.

Qualifications

• Ph.D. or equivalent in Pharmaceutical Sciences or Chemistry required.
• Minimum 7 years of related industry experience necessary.

Responsibilities

• Lead formulation development for peptide projects and optimize formulations.
• Maintain records for regulatory submissions and scientific publications.

Skills

Formulation Development

Peptide Delivery Systems

Analytical Techniques

Oral Formulation Discovery

Project Management

Education

Ph.D. in Pharmaceutical Sciences

Ph.D. in Chemistry

Tools

PAMPA

Caco-2 Cells

Liposomes

Lipid Nanoparticles

Job description

Job Description

We are seeking a highly motivated and experienced Director of Formulation Development at our Doylestown, PA site. The successful candidate will work within the discovery team and be responsible for developing formulations for our peptide project portfolio. The candidate must have demonstrated the ability to work collaboratively in a fast-paced, multidisciplinary, dynamic environment with excellent scientific and communication skills.

Key Responsibilities

1. Lead formulation development efforts for peptide projects.
2. Identify novel formulation solutions for ADME/PKPD studies to improve properties such as stability, solubility, and bioavailability of peptide leads, through internal efforts, external FTE team management, and external strategic partnerships.
3. Design formulations, including solid and liquid dosage forms, troubleshoot formulation-related issues, and optimize formulations based on results.
4. Maintain detailed records of experiments and contribute to regulatory submissions, scientific publications, and intellectual property initiatives covering discovery, preclinical, and clinical needs.
5. Conduct pre-formulation studies to assess the physicochemical properties of peptide APIs and excipients.
6. Develop and validate analytical methods for characterizing peptide formulations, including stability testing and impurity analysis.
7. Optimize formulation processes for development needs and ensure consistent drug product quality.

Required Qualifications

• Ph.D. or equivalent in Pharmaceutical Sciences, Chemistry, or a related field.
• Minimum 7 years of related industry experience.
• Experience in oral formulation discovery and process development, with a strong understanding of formulation principles, drug delivery systems, and analytical techniques.
• Demonstrated expertise in peptide delivery systems, preferably oral formulation with permeation enhancers and/or lipid nanocarriers to improve peptide bioavailability.
• Current knowledge of scientific literature and advancements in peptide formulation technologies, with the ability to identify vendors, collaborators, and opportunities for innovation and improvement.
• Availability for up to 10-20% travel domestically and internationally.

Preferred Experience & Skills

• Experience in managing project budgets, aligning actions with overall strategy, and supporting business cases for decision-making.
• Proven scientific contributions to projects, including co-inventorship on patents and/or co-authorship on publications and presentations.
• Experience in one or more of the following areas of peptide discovery:

• Permeation/absorption enhancer formulation design and optimization.
• Lipid-based formulation design and process development (liposomes, lipid nanoparticles, SEDDS/SMEDDS/SNEDDS).
• Tissue targeting formulation, including GI targeting and complex release mechanisms.
• High-throughput formulation screening for permeability enhancement using PAMPA, Caco-2 cells, or tissue organoids.

Additional Details

• Seniority level: Director
• Employment type: Full-time