Associate Director, Analytical Development & Clinical Quality Control

POSITION OVERVIEW:

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.

RESPONSIBILITIES:

This role will have extensive technical expertise and be responsible for method validation and method transfer for Disc Medicine’s clinical development programs. The technical responsibilities include:

• 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. 

REQUIREMENTS:

• 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 (GraphPad 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 CRF Part 11/210/211,820), and Guidance documents.
• Knowledge of technical writing for CMC sections of regulatory documents (IND, MAAs)
• Exceptional organizational, interpersonal, and communication skills, both verbal and written, with the ability to facilitate meetings, conduct training, and to present information in an advisory capacity.
• Attention to detail, excellent review skills, and the ability to organize and manage multiple tasks in a fast-paced environment.
• Able to travel up to 25%.
• Ability to work both independently and collaboratively with project teams and cross-functionally, to build productive relationships with internal and external partners, to influence decision-making, and to engage in conflict resolution.