Director of Formulation for Peptides

Contact: Matt Gendelman
Phone: (267) 541-3094

Position Overview

Our client is building a company to develop First and Best-In-Class Oral Peptides to achieve clinical success in a wide spectrum of therapeutic areas.

Key Responsibilities

• Lead formulation development efforts for peptide projects. 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.
• Design formulations, including solid and liquid dosage forms, troubleshoot formulation-related issues and optimize formulations based on results. Maintain detailed records of experiments and contribute to regulatory submissions, scientific publications and intellectual property initiatives to cover discovery, preclinical and clinical needs.
• Conduct pre-formulation studies to assess the physicochemical properties of peptide APIs and excipients; Develop and validate analytical methods for characterizing peptide formulations, including stability testing and impurity analysis; Optimize formulation processes for development need and ensure consistent drug product quality.

Key Requirements

• Ph.D. or equivalent in pharmaceutical sciences, chemistry, or a related field
• 7+ years of related industry experience is required.
• 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 enhancer and/or lipid nanocarriers to improve peptide bioavailability.
• Stay current with scientific literature and advancements in the field of peptide formulation technologies and identify vendors/collaborators/opportunities for innovation and improvement.
• Proven track record of scientific contributions to projects, including co-inventorship on patents and/or coauthorship on publications and presentations would be desirable.
• Experience in managing project budgets, aligning actions with overall strategy, and supporting business cases for decision-making is preferred.
• Up to 10 – 20% travel both domestically and internationally is required
• Experience in one or more of the following areas of peptide discovery is preferred:
• Permeation/absorption enhancer formulation design and optimization, through internal or collaborating with a partner.
• Lipid-based formulation design and process development (liposomes, lipid nanoparticles, SEDDS/SMEDDS/SNEDDS).
• Tissue targeting formulation, in particular GI targeting formulation and tablet/capsule engineering approaches, including time-delayed, sustained, site-specific or other complex release mechanisms.
• Hight-throughput formulation screening for enhanced permeability using PAMPA, caco-2 cell or tissue organoids.

Location: Greater Philadelphia

Location(s)

If interested, please send a MS Word version of your resume to [email protected]

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