Associate Director, Drug Product

Role Overview

• Provide leadership to multiple technical elements of drug product development for Disc Medicine’s biologic drug product programs.
• Lead selected clinical and/or commercial formulation studies for antibody and/or biologics programs.
• Lead drug product process development and characterization activities for selected unit operations supporting early and/or late-stage clinical programs up to and including process performance qualification batches (PPQ).
• If necessary, participate in selecting and recommending appropriate external providers (CMOs/CROs), to support formulation and fill/finish process development.
• Provide significant technical leadership to drug product process transfers to CMOs as well as oversee drug product formulation, process development, and manufacturing at contract development and manufacturing organizations (CDMO)s.
• Provide expertise across various areas of biologics drug product development, such as in-use compatibility, extractables/leachables, and filter validation studies.
• As necessary, contribute to device selection, design control, and/or validation activities for subcutaneous delivery systems, such as pre-filled syringes, needle safety devices, and/or autoinjectors.
• Form effective relationships and collaborate well with the CMC leader(s) and CMC functions, including drug substance, analytical development, quality control, supply chain, and quality and regulatory organizations.
• Contributed to the budget management of assigned programs.
• Engage with CMC and/or Executive Leadership, as appropriate, to proactively identify and communicate technical risks and provide scientific recommendations for mitigation plans.
• Contribute to a positive workplace culture that prioritizes collaboration, ensures accountability, and a commitment to continuous improvement.

Requirements

• A BS/MS in Chemical Engineering, Pharmaceutical Sciences, or similar areas is required.
• 10-15 years in the pharmaceutical / biopharmaceutical industry with a minimum of 4-6 years of hands-on experience with early and/or late-stage drug product development programs, such as formulation, process, and/or device development and technology transfer.
• Knowledgeable in sterile drug product development, technology transfer, and manufacturing.
• Experience in formulation development of antibody products through various stages of the product lifecycle, including first in human through to commercial formulations.
• Experience in contributing to the authoring drug product sections of early and late-stage clinical filings, as well as commercial filings, is highly preferred.
• Strong ability to communicate well with cross-functional groups, including Drug Substance, Analytical Development, Quality, Regulatory, and Program Management.
• Significant experience working within CMC teams and with CMC team leaders.
• Prior experience working with domestic and international CDMOs for development and GMP manufacturing activities, including person in plant support.
• Ability to contribute to high-performing teams, including exceptional communication as well as fostering cross-functional teamwork.
• Excellent collaboration and interpersonal skills with ability to convey complex ideas succinctly.
• Travel of 20-30% may be required.

Benefits

• comprehensive benefits
• competitive compensation packages
• flexible work environment