Associate Director, Biologics 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:

As Disc Medicine evolves from a clinical-stage to a commercial-stage organization, the Company has a new role for an Associate Director of Biologics Drug Products (BDP) reporting to the Executive Director of Drug Product Development. The successful candidate will be instrumental in driving the company’s growth trajectory and achieving strategic objectives.

The Associate Director of BDP will be responsible for providing leadership for one or more drug product assets across the biologics programs at Disc Medicine, focusing on antibodies or proteins. This role will encompass biologics formulation development, sterile drug product process development, and well as contribute to the implementation of subcutaneous delivery devices. There is a significant contribution, and leadership is expected from this role to enable early and late-stage regulatory filings of Disc Medicine assets. This position requires significant industry experience in the biologics formulation and drug product process area, with a focus on antibodies and proteins.

RESPONSIBILITIES:

• Lead one or more drug product teams for the biologics programs at Disc Medicine.
• Lead clinical and/or commercial formulation development for antibody programs.
• Lead drug product process development and characterization activities, up to and including process performance qualification batches (PPQ).
• Engage in selecting and recommending appropriate external providers (CMOs/CROs), to support formulation and fill/finish process development.
• As appropriate, engage in 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 studies.
• As necessary, contribute device selection, design, and/or validation 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 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 degree in Chemical Engineering, Pharmaceutical Sciences, or similar areas is required. MS or PhD is preferred.
• 10-12 in the pharmaceutical / biopharmaceutical industry as well as a minimum of 6-8 years’ experience leading early and/or late-stage drug product development team(s) is required.
• Demonstrated broad knowledge in sterile drug product development, technology transfer, and manufacturing.
• Prior experience in formulation development of antibody products through various stages of the product lifecycle, including first in human through to commercial formulations.
• Experience in authoring IND and BLA filings is highly preferred.
• Strong ability to communicate well with cross-functional groups, including Drug Substance, Analytical Development, Quality, Regulatory, and Program Management.
• Experience in managing project budgets is preferred.
• Significant experience working within CMC teams and with CMC leaders and related development team leaders.
• Prior experience with global antibody drug product CDMOs.
• Ability to contribute to high-performing teams, including exceptional communication as well as fostering cross-functional teamwork.
• Excellent collaboration and interpersonal skills and ability to convey complex ideas succinctly.
• 20-30% travel required

Disc Medicine is an equal-opportunity employer committed to providing all qualified candidates and employees equal opportunities. We offer comprehensive benefits and competitive compensation packages. The Company headquarters are in Watertown, MA, and we provide a flexible work environment. 

Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence. Interested candidates should submit a cover letter and resume to be considered for current and future opportunities.