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About Stylus Medicine: Stylus  Medicine is developing transformative  in vivo  genetic medicines to unlock cures.  Stylus  combines engineered recombinases with non-viral delivery to specifically encode therapeutics. The company’s approach is versatile and modular, with potential therapeutic application across oncology, autoimmune, genetic diseases, and beyond. About the Role: Stylus Medicine is seeking a Director of Analytical Development to provide strategic and technical leadership for analytical development within our portfolio. This individual will guide oversight of analytical method development, phase-appropriate qualification/validation of analytical methods for drug substance (DS) and drug product (DP), method transfer to CMOs, and support of regulatory filings, including investigational new drugs (INDs) and investigational medicinal product dossiers (IMPDs). Key Responsibilities & Accountabilities: Lead a high performing team of scientists and associates in setting and executing the analytical development and quality control strategy across portfolio programs Define and implement phase-appropriate analytical methods and control strategies to support DS and DP development Interpret and apply global regulatory guidelines (e.g., ICH, FDA) to assay development and lifecycle activities Define and drive potency assay strategy, aligning with product mechanism of action, CQA frameworks, and regulatory expectations Act as a company liaison with contract laboratories, coordinating method transfers and overseeing method qualification and validation activities Advise and oversee CDMOs’ analytical method development, validation and transfer Ensure analytical methods and specifications are scientifically justified, phase appropriate, and compliant with applicable compendial standards and regulatory guidelines Review and approve analytical methods, validation protocols, analytical reports, and stability protocols and test reports Oversee the reference standard program, including establishing and maintaining reference standards, approving qualification protocols and reports, and coordinating release testing at external laboratories Drive resolution of investigations, deviations, and comparability assessments Collaborate with Quality Assurance to review and manage change controls and quality event documentation Establish best practices internally and externally for analytical lifecycle management, data integrity, documentation, and knowledge transfer Partner cross-functionally to support data-driven decision-making and operational excellence Provide analytical CMC leadership for regulatory filings, including INDs and IMPDs with direct responsibility for authoring and reviewing analytical sections Travel may be required Qualifications & Skills: PhD in Biochemistry, Molecular Biology (or) Chemical / Biological Engineering with 10+ years of progressive industry experience in leading analytical method development, validation, regulatory submissions and lifecycle management Proven experience as a functional leader, including team leadership and accountability for analytical strategy execution Demonstrated expertise in compendial methods, high-throughput sequencing (e.g., NGS, RNA-seq) bioanalytical methods (e.g., ddPCR, RT-PCR, ELISA, DLS) and chromatographic techniques (e.g., LC), employing detectors such as UV/vis, CAD, MS, fluorescence Experience managing stability studies, protocol development and performing trending analysis, OOS/OOT investigations, root cause analysis, etc. Demonstrated track record of successful method transfers to CROs/CDMOs Attention to detail and accuracy in developing and reviewing SOPs, batch records and technology transfer documents Strong knowledge of global regulatory requirements and ICH guidelines applicable to analytical development and control strategies Experience in authoring/contributing to Mod