Director, Analytical Development and Clinical Quality Control

Role Summary

Director role responsible for managing clinical quality control functions internally and across multiple contract development and manufacturing organizations (CDMOs) for Disc's biologics pipeline programs. Reports to the Head of Analytical Development and Clinical Quality Control (ADQC) in Technical Operations. Requires expert knowledge of the biopharmaceutical drug development process from pre-clinical to post-approval changes, with experience in quality systems, product specifications, analytical method validation, transfer, method lifecycle management, and stability programs. Location: hybrid remote with headquarters in Watertown, MA.

Responsibilities

• Lead the clinical QC function for Disc Medicine biologics pipeline programs from early development to commercialization.
• Support, in collaboration with the CMC function, the selection of analytical and QC CDMOs. Negotiate, obtain, and review for service agreements and related statements of work for development activities with external partners.
• Develop strong relationships with external CDMO partners to establish and manage appropriate scopes of work, and to ensure all activities are within program expectations.
• Guide the qualification and validation of analytical methods to support the GMP in-process, batch release and stability studies. Review and approve protocols and reports.
• Establish appropriate training and technical approaches to transfer analytical methods from method development sites to QC testing sites, if applicable.
• Establish and implement product specifications, oversee outsourced GMP release testing, stability programs and reference standard management at CDMOs.
• Accountable for QC OOS/OOT/deviation investigations. Identify root cause and CAPA for testing-related issues.
• Support quality assurance in product release activities and product shelf-life management.
• Establish system and procedures for product and reference standard trending. Review and approve trend reports periodically.
• Author, review, approve SOPs, protocols, reports, and change controls.
• Support annual product review and annual report activities.
• Represent quality control operations for Disc Medicine in regulatory and partner audits.
• Author and review global health authority CMC dossier sections for clinical trials and commercial licensure.
• Foster a positive workplace culture that prioritizes collaboration, ensures accountability and commitment to continuous improvement.

Qualifications

• 12+ years of related experience in the biopharmaceutical industry.
• Comprehensive knowledge of cGMP and global regulatory requirements.
• Prior experience in leading quality control functions.
• Experience in IND and BLA filings is highly desired.
• Expert knowledge of the biopharmaceutical drug development process from pre-clinical to post-approval changes, with working knowledge and experience in quality systems, product specification establishment, analytical method validation, transfer, and method lifecycle management.
• Ability to collaborate well with cross-functional groups, including Process Development, Manufacturing, Quality, Regulatory and Program Management.
• Self-starter with demonstrated ability to deliver high-quality results in a fast-paced development environment. Ability to effectively prioritize and deliver on tight timelines.
• Excellent communication and interpersonal skills; ability to convey complex ideas succinctly.

Education

• B.S. degree required.
• Advanced degree (M.S./Ph.D.) preferred.