Executive Director, Biologics Drug Product
Massachusetts - Hybrid
Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA.
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.
As Disc Medicine evolves from a clinical-stage to a commercial-stage organization, the Company has a new role for an Executive Director (ED) of Biologics Drug Products (BDP). The successful candidate will be instrumental in driving the company’s growth trajectory and achieving strategic objectives.
The ED of BDP will be responsible for providing leadership over all drug product activities across the biologics programs at Disc Medicine, focusing on antibodies. This role will encompass biologics formulation development and sterile drug product process development. There will be a significant contribution, and leadership is expected from this role to enable regulatory filings of Disc Medicine assets. This position requires a minimum of 15 years of industry experience in the biologics formulation and drug product process area, with a focus on antibodies and proteins in general.
RESPONSIBILITIES :
* Lead the drug product function for biologics programs at Disc Medicine
* Oversee drug product manufacturing at contract development and manufacturing organizations (CDMO)s
* Lead commercial formulation development for antibodies
* Engage in selecting appropriate external providers, including formulation and fill/finish process development.
* Provide expertise in various areas of biologics drug product, such as in-use compatibility studies.
* As appropriate, engage in drug product transfer from one site to another
* Manage a team of individuals and build the function that is poised for growth along with the rest of the company
* Form effective relationships and collaborate well with the CMC leader and CMC functions, including drug substance, analytical development, quality control, supply chain, and quality and regulatory organizations.
* Engage with Executive Leadership as appropriate to proactively identify technical risks and provide scientific recommendations for mitigation
* Foster a positive workplace culture that prioritizes collaboration, ensures accountability, and a commitment to continuous improvement.
REQUIREMENTS :
* B.S. degree is required. Advanced scientific degree Ph.D. in a related field is highly preferred.
* 15+ years of operations experience in the pharmaceutical/biopharmaceutical industry with a minimum of 12 years of leadership experience in leading antibody drug product development teams.
* 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 and commercial formulations
* Experience in 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
* Demonstrated ability in managing a department and associated budget
* Substantial experience working in CMC teams – with CMC leaders and related team leaders. Preferred to have experience as a CMC leader
* Strong network and prior experience with antibody drug product CDMOs
* Ability to provide excellent leadership to develop high-performing teams, including exceptional communication and one-team spirit
* Excellent collaboration and interpersonal skills; Ability to convey complex ideas succinctly
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.
J-18808-Ljbffr