Hybrid Principal Scientist/Associate Director, Analytical Development, Clinical Quality Control

at Disc Medicine

• Job title: Principal Scientist/Associate Director, Analytical Development, Clinical Quality Control
• Job type: Full Time
• Experience level: Senior
• Salary: $146,200 - $197,800 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Watertown, United States

About the role

• Principal Scientist/Associate Director contributing to late-stage analytical development for biopharmaceuticals at Disc Medicine. Overseeing method development and compliance with regulatory standards in a hybrid work environment.

Responsibilities

• Characterize biologic therapeutics using standard analytical extended techniques to explore relationships between structure and function.
• Oversee development of standard protein analysis methods through external vendors and guide transfer analytical methods to separate analytical and QC testing facilities.
• Develop analytical techniques to measure product and process impurities.
• Strengthen relationships with external CDMO partners to establish and manage appropriate scopes of work.
• Provide oversight into external testing facilities for non-GMP and GMP testing.
• Lead method performance investigations, troubleshooting, and laboratory investigations.
• Working and up-to-date knowledge of ICH guidelines and other regulatory guidance.
• Author, review and edit SOPs, protocols, reports, and quality related documentation.

Requirements

• S. degree is required. An advanced degree (M.S./Ph.D.) is preferred.
• 10-12+ years of related experience in the biopharmaceutical industry experience, with 2+ years in late-stage development of antibody or related therapeutics.
• Hands-on experience with multiple analytical methods and specification development; troubleshooting experience with analytical methods using external vendors
• Good knowledge of cGMP and global regulatory requirements.
• Develop relationships and collaborate well with cross-functional groups, including Process Development, Manufacturing, Quality, and Regulatory.
• 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 while remaining flexible in a changing environment.
• Excellent communication and interpersonal skills; ability to convey complex ideas succinctly.
• Experience in IND and BLA filings is highly desired.
• Ability to travel occasionally

Benefits

• Comprehensive benefits
• Competitive compensation packages