Associate 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.

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.

The Associate Director of Quality Control will manage quality activities for biologics programs in clinical development, ensuring compliance with ICH and GMP guidelines. The primary functions include method validation and method transfers to and from CDMOs. Additionally, this role will lead and or participate in specification setting activities for early and late-stage biologics programs as well as manage method life cycle.

Significant contributions from this role will be essential for facilitating regulatory filings of Disc Medicine assets.

This position reports to the Director of Analytical Development and Clinical Quality Control within the Technical Operations organization at Disc Medicine. The ideal candidate should have 10-12 years of experience in quality control management in the pharmaceutical or biotech industry.

• Author, review, and approve method transfer protocols and reports from transferring and receiving CDMOs per regulatory requirements.
• Author, review, and approve method validation protocols and reports from transferring and receiving CDMOs per regulatory requirements.
• Author, revise, and approve governing SOPs, protocols, reports and memos in accordance with current GMP, ICH, and global regulatory guidelines.
• Lead or participate in specification setting activities for early and late-stage biologics programs.
• Manage method lifecycle, including periodic reviews to assess method performance.
• Manage Quality System records for QC activities: author, assess, review Deviations, Change Controls, CAPAs, and other applicable quality-related investigations and events.
• Support GMP audits and inspections.
• Act as the team leader to ensure alignment and effective communication among cross-functional areas, including analytical development, process development, formulation development, manufacturing, supply chain, regulatory, quality assurance, and other internal and external partners.
• Design and improve processes to ensure compliance with global regulatory requirements.
• Establish and maintain a network of external partners to fulfill technical and capacity requirements.
• Support the budget planning and resource allocation to support laboratory operations and staffing.

• A B.S. degree is required; an advanced degree (e.g., M.S./Ph.D.) in a related field is preferred.
• At least 10-12 years of experience in the biopharmaceutical industry, including prior leadership experience in quality control functions.
• Experience with a track record of method validation, method transfer, and hands‑on management of day‑to‑day testing operations for outsourced biologics therapeutics.
• Knowledge of statistics and statistical tools (Graph Pad Prism, JMP) to assist in trending and or specification setting.
• Knowledge of Quality processes such as change control, CAPAs, and deviations.
• Experience and knowledge with Root Cause Analysis tools for OOS investigations is a plus.
• Experience conducting QC OOS investigations and write‑ups in conjunction with CDMOs.
• Experience with Veeva, LIMS and Smartsheet desirable.
• Knowledge of bioanalytical and analytical methods, including but not limited to LC‑MS, GC‑MS, UV‑vis, IR/FT‑IR, HPLC (SEC, icIEF), CE‑SDS, ELISA, cell‑based potency assays.
• Working knowledge of quality systems, global regulatory requirements (example: 21 CFR Part 11/210/211,820), and Guidance documents.
• Knowledge of technical writing for CMC…