Associate Director, Drug Product

Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA. COMPANY OVERVIEW: Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis.

Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires. 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.