Associate Director, Drug Product

POSITION OVERVIEW:

Reporting to Executive Director, Biologics Drug Product; the Principal Scientist / Associate Director in Biologics Drug Product Development will be responsible for providing leadership for drug product technical elements of assets within the biologics pipeline programs, focusing on antibodies and/or proteins. The technical elements of this role may be responsible encompass biologics formulation development, drug product process development, technology transfer and manufacturing support, as well as development of subcutaneous delivery devices. This role will also be expected to contribute to authoring early and late-stage clinical filings as well as commercial filings. This position requires significant hands-on industry experience in the biologics formulation and drug product process development and manufacturing support areas, with a focus on antibodies and proteins.

RESPONSIBILITIES:

• 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.