Director, Analytical Development & Clinical Quality Control

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 commercial stage organization, the Company has a new role for a Director of Analytical Development and Clinical Quality Control. The successful candidate will be instrumental in driving the company’s growth trajectory and achieving strategic objectives.

The Director of AD/QC will be responsible for providing leadership over analytical development activities across the small molecule and biologics programs at Disc Medicine. In addition, this role will be responsible for the oversight of clinical quality control and stability studies performed at contract development and manufacturing organizations (CDMOs). There will be a significant contribution expected from this role to enable regulatory filings of Disc Medicine assets.

RESPONSIBILITIES:

• Lead the analytical development activities for Disc Medicine pipeline programs. Guide the development, qualification and validation of physicochemical, immunological, functional and impurity methods to support the characterization, GMP lot release, stability and in-process testing.
• Establish appropriate training and technical approaches to transfer analytical methods from development sites to external QC testing sites.
• Oversee GMP lot release testing, stability programs and reference standard management at CDMOs.
• Lead OOS/OOT investigations, deviations and CAPA.
• Support quality assurance in product release activities and establish procedural documents.
• Support GMP inspections and audits.
• Author and review global health authority dossier sections for clinical trials and commercial licensure. Support regulatory inspections and audits.

 REQUIREMENTS:

• S. degree is required. Advanced degree e.g. M.S./Ph.D. in a related field is preferred.
• 10+ years of biopharmaceutical industry and/or academic research experience.
• Prior experience in leading analytical development and/or quality control functions.
• Experience in IND and BLA filings is highly preferred.
• Strong ability to communicate well with cross-functional groups including Process Development, Manufacturing, Quality, Regulatory and Program Management.
• Ability to provide excellent leadership to develop high performing teams including exceptional communication and a one-team spirit.
• Excellent collaboration and inter-personal skills with 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.