Senior Scientist, Analytical Development & Quality Control

As a Senior Scientist in ADQC, you will shape analytical strategies for small molecules and peptides from early development through late-stage programs, driving method development, validation, and control strategies for DS/DP. You will lead internal analytics, coordinate with CDMOs, and collaborate across Drug Substance, Drug Product, QA, Regulatory, and Clinical teams to meet program goals. This role offers hands-on technical leadership in a fast-paced biotech environment and a chance to impact regulatory-ready analytics. You will work on high-impact projects that accelerate development timelines while ensuring data integrity and GMP compliance.

• Health and wellness program with comprehensive coverage
• Premium medical, dental, and vision insurance
• 401(k) plan
• Flexible vacation policy
• Company-paid lunch and snacks
• FSA options (Healthcare, Dependent Care, Commuter)

• Develop, optimize, and validate analytical methods for release, stability, and characterization of DS and DP
• Lead impurity identification, degradant analysis, comparability assessments, method transfer, and lifecycle management
• Establish phase-appropriate analytical control strategies with characterization plans and specifications
• Troubleshoot analytical issues, conduct investigations (OOS/OOT, deviations, root-cause, CAPA, change control)
• Manage stability and reference standard programs for assigned projects
• Coordinate with CDMOs and review their data for release, stability, and characterization
• Draft analytical sections for INDs, IMPDs, and NDAs; contribute to Module 3
• Drive continuous improvement in processes, CDMO management practices, and SOPs in collaboration with QA
• Represent ADQC in cross-functional meetings

• PhD or MS in Analytical Chemistry or a related discipline with 5+ years in early- and late-stage CMC development
• Hands-on UHPLC method development with diverse detectors (UV, PDA, MS, etc.)
• Experience developing methods for synthetic peptides or complex drug substances (ADCs, PEGylated proteins, mAbs) is highly preferred
• Proven ability to solve complex scientific and business challenges
• Experience managing analytical development and QC activities at CDMOs
• Strong knowledge of cGMP/GLP, pharmaceutical quality systems, and regulatory requirements
• Excellent written and verbal communication, able to present plans to CDMOs and senior management
• Ability to manage priorities, timelines, and risk in a fast-paced setting
• Strong project management, leadership, and cross-functional collaboration skills
• Travel flexibility domestically and internationally as needed

• strong communication
• leadership
• cross-functional collaboration
• UHPLC method development
• MS-based identification and characterization
• degradant and impurity analysis