Disc Medicine · 2 months ago
Principal Scientist/Associate Director, Analytical Development & Clinical Quality Control
Massachusetts - Hybrid
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$146K/yr - $198K/yr
10+ years expDisc Medicine is a clinical-stage biopharmaceutical company focused on developing novel treatments for hematologic diseases. The Principal Scientist/Associate Director will lead analytical development strategies, oversee method development, and ensure compliance with regulatory standards while collaborating with cross-functional teams.
BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
Responsibilities
Characterize biologic therapeutics using standard analytical extended techniques to explore relationships between structure and function. These techniques include but are not limited: chromatographic techniques (CEX, SEC, HILIC, etc.), mass spectrometry-based techniques including peptide mapping (LC/MS) and intact mass, capillary electrophoresis, differential scanning calorimetry (DSC) or fluorimetry (DSF), glycosylation content measurement, ELISA, and potency assays
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, and to ensure all activities are within program expectations
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 for internal and external stakeholders
Provide authorship and review for regulatory documents for multiple countries
Collaborate cross-functionally across multi-disciplinary teams including Analytical Development, Process Development, Drug Product Development, Regulatory, Quality Assurance, Supply Chain, and others
Qualification
Required
S. degree is required
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
Ability to travel occasionally
Preferred
An advanced degree (M.S./Ph.D.) is preferred
Experience in IND and BLA filings is highly desired
Benefits
Comprehensive benefits
Competitive compensation packages
Company
Disc Medicine
Disc Medicine is a biopharmaceutical company that develops therapies for hematologic diseases and rare blood disorders.
51-200 employees
H1B Sponsorship
Disc Medicine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.29BKey Investors
Hercules CapitalFrazier Life SciencesBain Capital Life Sciences
2025-10-21Post Ipo Secondary· $25M
2025-10-21Post Ipo Equity· $225M
2025-01-22Post Ipo Equity· $225.5M
Leadership Team
Jean Franchi
Chief Financial Officer
Jonathan Yu
Chief Operating Officer
Recent News
2026-01-07
Company data provided by crunchbase