Sr Director, Analytical Development

Job Summary Sr. Director of Analytical Development (AD) provides strategic and technical leadership for analytical development across the pipeline, from discovery through marketing approval and product lifecycle management. Responsibilities Lead and develop an organization (Directors to Research Associates) accountable for science‑based, phase‑appropriate analytical strategies from raw materials through drug product aligned to clinical plans, business objectives, and regulatory expectations. Lead and continuously enhance analytical methods and technologies; translate innovation into robust, scalable commercial testing platforms. Lead analytical method transfer strategies to Quality Control and external CDMOs/CTLs. Provide leadership for characterization of raw material, intermediate, drug substance, and drug product; apply fit‑for‑purpose technologies to assign critical quality attributes (in partnership with Advanced Characterization). Partner with Advanced Analytical Technology to define/execute the AD technology roadmap and deploy innovative technologies to modernize control strategies, accelerate development, improve quality, and support next‑generation manufacturing/testing. Manage Module 3 analytical content and data packages for IND/CTA, NDA/MAA/BLA and lifecycle submissions; support responses to health authority questions. Establish/maintain project plans, timelines, budgets, and resource/capacity; manage headcount by program; identify/escalate delivery risks. Provide technical leadership aligned to industry standards and global regulatory guidance; make critical scientific decisions. Lead and develop talent through hiring, coaching, performance management, succession planning, and development. Represent function in cross‑functional governance; build alliances with Drug Substance, Drug Product, Regulatory, Quality, Manufacturing, and external partners/CMOs/CTLs. Ensure compliance with corporate policies/procedures and quality systems, including cGMP. Foster an innovative, inclusive, execution‑focused environment. Lead cross‑functional teams; influence with and without formal authority. Engage with regulatory agencies as an analytical subject‑matter expert when required. Build external networks (vendors, consortia, academic/corporate partners). Qualifications Ph.D. in Chemistry/Analytical Chemistry/Chemical Engineering/Biochemistry (or related); 12+ years with graduate degree or 14+ years with BA/BS; expertise in pharmaceutical/biopharmaceutical analytical development/product characterization. Demonstrated senior leadership leading technical organizations and delivering through others. Deep expertise in phase‑appropriate control strategy development and analytical method development/transfer to Quality. Working knowledge of cGMP, data integrity expectations, and global regulatory requirements; experience supporting US and international filings. Strong communication/presentation skills. Small‑molecule analytical development across lifecycle: HPLC/UPLC, mass spectrometry, impurity methods, stability, comparability, method validation, and test transfer. Ability to craft technical/innovation strategies and implement new methodologies to improve capability, robustness, and productivity. Ability to solve complex quality/regulatory/scientific problems under aggressive timelines. Benefits Salary range: $243,100.00–$314,600.00; may include discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility varies), paid time off, and benefits (company‑sponsored medical, dental, vision, life insurance). #J-18808-Ljbffr Scorpion Therapeutics