Director, Quality Analytical Technical Lead, Small Molecule

Accountabilities

• • Serve as the global point of contact and accountable owner for analytical matters associated with assigned commercial small-molecule products across major markets, including the US, EU, China, Australia, and Canada, while supporting expansion into additional regions.
  • Provide technical governance and leadership across analytical activities for drug substance, drug product, and applicable critical raw materials and reagents.
  • Translate global product strategies into clear analytical expectations, priorities, and deliverables for internal quality control sites, external laboratories, contract manufacturing organizations, and other technical partners.
  • Lead and approve strategies for analytical investigations, including OOS, OOT, OOE, atypical results, invalidations, root-cause assessments, CAPA, and method optimization.
  • Drive analytical change-control strategies and execution plans covering method updates, revalidation or verification, reference-standard changes, and instrument or software upgrades.
  • Manage escalation of supply-critical analytical issues and align resolution strategies across Quality, Regulatory, Supply Chain, and other relevant functions.
  • Own global processes and technical knowledge related to commercial analytical method lifecycle management, including validation and verification strategies, transfers, periodic reviews, trending, and robustness improvements.
  • Govern global release and stability specifications, supporting harmonization, lifecycle updates, and scientifically justified changes.
  • Lead stability-program strategy, including protocols, regulatory commitments, pull schedules, trend evaluation, and annual review narratives.
  • Provide governance for retest periods and shelf life, including extensions, commitments, labeling considerations, and country-specific requirements.
  • Ensure development-to-commercial handover of submission-ready analytical documentation, including control strategies, method histories, validation packages, specification rationales, and stability narratives.
  • Maintain alignment between analytical control strategies and product risk profiles, including critical quality attributes, critical process parameters, and small-molecule impurity controls.
  • Provide analytical subject matter expertise for global regulatory submissions, including Module 3 sections, stability commitments, post-approval variations, supplements, comparability narratives, and analytical bridging.
  • Partner with Regulatory CMC teams on health-authority interactions and responses concerning analytical controls, stability trends, and specification justification.
  • Provide governance and oversight for external quality-control networks, including expectations, performance metrics, investigation quality, and escalation pathways.
  • Support audits and regulatory inspections as the product analytical SME and ensure assigned products and analytical systems remain inspection-ready.
  • Influence laboratory capacity planning and capability investments through risk-based technical assessments.

  Requirements

  • Bachelor’s degree with 10+ years of biopharmaceutical experience, including significant responsibility for commercial product lifecycle management; a Master’s degree with 7+ years or a doctoral degree with 5+ years of relevant experience is preferred.
  • Demonstrated leadership experience in GMP Quality Control and/or analytical sciences, particularly supporting commercial small-molecule products.
  • Strong technical expertise in small-molecule analytical methods, including HPLC/UPLC, GC, dissolution, residual solvents, elemental impurities, and genotoxic impurities, as applicable.
  • Strong working knowledge of analytical method validation and verification, stability trending and statistical evaluation, specification lifecycle management, and data integrity.
  • Experience making scientifically sound, risk-based decisions across analytical investigations, method changes, specifications, stability programs, and lifecycle activities.
  • Understanding of global GMP, pharmacopeial, and regulatory expectations and the ability to produce documentation and narratives that withstand regulatory inspection.
  • Experience supporting regulatory submissions, post-approval changes, analytical comparability, and health-authority interactions is highly valuable.
  • Strong ability to lead through influence within a matrix organization, with excellent stakeholder management, negotiation, and cross-functional collaboration skills.
  • Excellent technical writing and communication capabilities, with the ability to explain complex analytical and quality topics clearly to scientific, quality, regulatory, and business stakeholders.
  • Strong program and risk-management mindset, including the ability to prioritize effectively in supply-constrained or time-sensitive environments.
  • Strong analytical thinking, problem-solving, initiative, adaptability, and results orientation.
  • Comfortable working collaboratively across geographically distributed internal teams and external partners.
  • Strong proficiency with standard business software, including Microsoft Office applications such as Outlook, Word, Excel, and PowerPoint.
  • Willingness and ability to travel internationally or domestically as required, with travel expected to be up to 20%.

  Benefits

  • Annual base salary range of $168,000–$228,000, with actual compensation determined by experience, skills, qualifications, education, certifications, and work location.
  • Eligibility for an annual bonus plan for non-commercial roles.
  • Opportunity to receive discretionary equity awards and participate voluntarily in an Employee Stock Purchase Plan.
  • Comprehensive medical, dental, and vision insurance.
  • 401(k) retirement plan.
  • Flexible Spending Account (FSA) and Health Savings Account (HSA) options.
  • Life insurance coverage.
  • Paid time off and wellness benefits.
  • Remote-based position within the United States.
  • Opportunity to work on global commercial product portfolios and collaborate with multidisciplinary teams across international markets.
  • Exposure to complex analytical lifecycle, quality, regulatory, and supply challenges within a rapidly growing biopharmaceutical environment.
  • Inclusive workplace focused on collaboration, continuous learning, scientific excellence, and patient impact.