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

Disc Medicine•Massachusetts, MA

47d•Hybrid

About The Position

Reporting to a Director of Analytical Development/Clinical QC, this position requires expert knowledge of the biopharmaceutical drug development process in late-stage development, with working knowledge and experience in method development, transfer of analytical methods, and management of external vendors. This individual will contribute to late-stage analytical development strategy and content of regulatory filings. Excellent communication skills, attention to detail, and organizational skills are essential for this role.

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

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.