Senior Scientist Analytical Development & Quality Control

Responsibilities

• Develop, optimize, and validate analytical methods for release, stability, and characterization testing of DS and DP.
• Lead impurity identification, degradant analysis, comparability assessments, method transfer, and analytical method lifecycle management.
• Establish phase-appropriate, scientifically robust analytical control strategies, including characterization plans and specification setting, to support clinical and regulatory requirements and enable accelerated development timelines.
• Troubleshoot analytical issues and support investigations, including OOS/OOT results, deviations, root-cause analysis, CAPA recommendations, and change-control activities, as applicable.
• Manage stability and reference standard programs for assigned projects.
• Communicate effectively with stakeholders and manage analytical development and QC testing activities at CDMOs.
• Review CDMO data for release testing, stability testing, and DS/DP characterization to ensure scientific rigor, data integrity, and compliance.
• Author analytical sections for regulatory filings, including INDs, IMPDs, and NDAs, and provide input to relevant Module 3 sections.
• Participate in continuous improvement initiatives, including process and workflow improvements, CDMO management practices, and SOP development or revision in collaboration with Quality Assurance.
• Represent ADQC in cross-functional team meetings.

Qualifications

• PhD or MS in Analytical Chemistry or a relevant scientific discipline, with 5+ years of experience supporting early- and late-stage CMC development.
• Hands-on expertise in UHPLC method development using a range of detection technologies, including UV, PDA, MALS, CAD, conductivity, fluorescence, and advanced MS for identification and structural characterization.
• Extensive experience developing analytical methods for synthetic peptides or similarly complex drug substance molecules, such as ADCs, PEGylated proteins, or monoclonal antibodies, is highly preferred.
• Demonstrated ability to solve complex scientific and business challenges.
• Extensive experience communicating with and managing analytical development and QC functions at CDMOs.
• Strong knowledge of cGMP/GLP compliance, pharmaceutical quality systems, and regulatory requirements for drug development.
• Excellent written and verbal communication skills, with the ability to effectively represent analytical development plans to CDMOs, internal project teams, CMC teams, and senior management.
• Ability to manage priorities and maintain timelines in a fast-paced environment while balancing speed, quality, and risk.
• Strong project management, communication, leadership, and cross-functional collaboration skills.
• Experience in small- to mid-size innovator companies is desired.
• Ability to travel domestically and internationally, as needed.