Associate Director, Analytical Development and Quality Control

• Support analytical development and QC activities related to characterization of drug substances and drug products from early-stage clinical development through commercialization
• Maintain current knowledge in analytical methods and control strategies supporting a variety of molecule platforms and dosage forms
• Oversee and provide scientific leadership on QC testing for DS/DP at vendors, ensuring cGMP compliance, data integrity, and timely delivery of analytical results
• Direct investigations including OOS/OOT, deviations, and CAPAs, and provide strong analytical rationale
• Design and manage stability programs (accelerated, long-term, bracketing/matrixing) supporting early and late clinical phases
• Interpret stability trends and establish shelf-life/retest periods consistent with ICH guidelines and peptide behavior
• Support comparability assessments for process changes, analytical method updates, or site transfers
• Communicate CMC project status to key stakeholders cross-functionally and assist in driving decision-making
• Participate in cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed
• Author and review CMC sections of IND/IMPD and NDA submissions and address regulatory questions
• Prepare for audits/inspections and represent analytical and QC functions to regulatory authorities
• Lead, mentor, and develop analytical and QC staff while driving continuous improvement and phase-appropriate analytical strategies

• 10+ years of experience, or 5+ with advanced degree, in the pharmaceutical/biotech industry with experience in all phases of innovative drug development and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.)
• Strong expertise in analytical techniques HPLC/UPLC, LC–MS, SE-HPLC, dissolution, along with extractables and leachable analysis
• Knowledge of drug development activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements
• Hands-on experience supporting early- and late-stage CMC development, stability programs, and specification setting
• Proven experience leading OOS/OOT investigations, deviations, CAPAs, and change controls
• Strong track record of working with CROs/CMOs and managing external analytical/testing activities
• Excellent technical writing skills for analytical reports and regulatory submissions (IND/IMPD, NDA/BLA)
• Demonstrated leadership ability with experience mentoring and developing scientific staff
• Strong communication, cross-functional collaboration, and project-management skills
• Innovative team-player with high energy for our dynamic company environment
• A bachelor’s degree with 10+ years or an advanced degree with 5+ years of relevant experience
• Degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field

Prior peptide product development including familiarity with peptide manufacturing, characterization, formulation, and stability experience is preferred

• Comprehensive health benefits and tax-advantaged savings accounts
• Flexible time off, 13 paid holidays, and a companywide year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Disability and life insurance