Disc Medicine

Associate Director, Drug Product

Massachusetts - Hybrid · Director

Sponsorship not specified$10k-$15kDetected 65 days ago

Product ManagementSupply ChainGMPLeadershipCommunicationCollaboration

About the role

Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires.
This role will also be expected to contribute to authoring early and late-stage clinical filings as well as commercial filings.

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.
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.
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 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.

A BS/MS in Chemical Engineering, Pharmaceutical Sciences, or similar areas is required.
Experience in formulation development of antibody products through various stages of the product lifecycle, including first in human through to commercial formulations.
Strong ability to communicate well with cross-functional groups, including Drug Substance, Analytical Development, Quality, Regulatory, and Program Management.
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.

Experience in contributing to the authoring drug product sections of early and late-stage clinical filings, as well as commercial filings, is highly preferred.

$167,000 - $205,000 USD
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.
Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence. Interested candidates should submit their resume to be considered for current and future opportunities.
Disc Medicine respects your privacy.

The Company headquarters are in Watertown, MA, and we provide a flexible work environment.

Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases.

This listing is sourced directly from Disc Medicine's careers page and normalized into a canonical job model.