Principal Scientist/Associate Director, Analytical Development & Clinical Quality Control
Disc Medicine
July 02, 2026
Remote friendly (Watertown, MA)
United States
Operations
Position Overview:
Reporting to a Director of Analytical Development/Clinical QC, this role requires expert knowledge of the biopharmaceutical drug development process in late-stage development, including method development, transfer of analytical methods, and management of external vendors. Contributes to late-stage analytical development strategy and regulatory filing content.
Responsibilities:
- Characterize biologic therapeutics using extended analytical techniques (e.g., CEX/SEC/HILIC; LC/MS peptide mapping and intact mass; capillary electrophoresis; DSC/DSF; glycosylation content; ELISA; potency assays).
- Oversee standard protein analysis method development via external vendors; guide transfer of analytical methods to analytical and QC testing facilities.
- Develop analytical techniques to measure product and process impurities.
- Manage external CDMO partner relationships and scopes of work to meet program expectations.
- Provide oversight into external testing facilities (non-GMP and GMP).
- Lead method performance investigations, troubleshooting, and laboratory investigations.
- Maintain up-to-date knowledge of ICH guidelines and other regulatory guidance.
- Author/review/edit SOPs, protocols, reports, and quality documentation for internal and external stakeholders.
- Author/review regulatory documents for multiple countries.
- Collaborate cross-functionally with Analytical Development, Process Development, Drug Product Development, Regulatory, Quality Assurance, Supply Chain, and others.
Requirements:
- Bachelor’s degree required; M.S./Ph.D. preferred.
- 10–12+ years biopharmaceutical industry experience; 2+ years in late-stage antibody/related therapeutics development.
- Hands-on experience with multiple analytical methods and specification development; troubleshooting with vendor-based analytical methods.
- Good knowledge of cGMP and global regulatory requirements.
- Strong cross-functional collaboration and relationship-building.
- Self-starter; can prioritize and deliver on tight timelines in a changing environment.
- Excellent communication and interpersonal skills.
- IND and BLA filing experience highly desired.
- Ability to travel occasionally.
Application Instructions:
- Submit your resume to be considered for current and future opportunities.
Reporting to a Director of Analytical Development/Clinical QC, this role requires expert knowledge of the biopharmaceutical drug development process in late-stage development, including method development, transfer of analytical methods, and management of external vendors. Contributes to late-stage analytical development strategy and regulatory filing content.
Responsibilities:
- Characterize biologic therapeutics using extended analytical techniques (e.g., CEX/SEC/HILIC; LC/MS peptide mapping and intact mass; capillary electrophoresis; DSC/DSF; glycosylation content; ELISA; potency assays).
- Oversee standard protein analysis method development via external vendors; guide transfer of analytical methods to analytical and QC testing facilities.
- Develop analytical techniques to measure product and process impurities.
- Manage external CDMO partner relationships and scopes of work to meet program expectations.
- Provide oversight into external testing facilities (non-GMP and GMP).
- Lead method performance investigations, troubleshooting, and laboratory investigations.
- Maintain up-to-date knowledge of ICH guidelines and other regulatory guidance.
- Author/review/edit SOPs, protocols, reports, and quality documentation for internal and external stakeholders.
- Author/review regulatory documents for multiple countries.
- Collaborate cross-functionally with Analytical Development, Process Development, Drug Product Development, Regulatory, Quality Assurance, Supply Chain, and others.
Requirements:
- Bachelor’s degree required; M.S./Ph.D. preferred.
- 10–12+ years biopharmaceutical industry experience; 2+ years in late-stage antibody/related therapeutics development.
- Hands-on experience with multiple analytical methods and specification development; troubleshooting with vendor-based analytical methods.
- Good knowledge of cGMP and global regulatory requirements.
- Strong cross-functional collaboration and relationship-building.
- Self-starter; can prioritize and deliver on tight timelines in a changing environment.
- Excellent communication and interpersonal skills.
- IND and BLA filing experience highly desired.
- Ability to travel occasionally.
Application Instructions:
- Submit your resume to be considered for current and future opportunities.