Director, Analytical Development

About the Company

Stylus Medicine is developing transformative in vivo genetic medicines to unlock cures. The company combines engineered recombinases with non-viral delivery to specifically encode therapeutics across oncology, autoimmune, and genetic diseases.

Responsibilities

• Lead a high performing team of scientists in setting and executing analytical development and quality control strategies
• Define and implement phase-appropriate analytical methods and control strategies for DS and DP development
• Drive potency assay strategy aligned with product mechanism of action and regulatory expectations
• Act as company liaison with contract laboratories, coordinating method transfers and overseeing qualification and validation
• Provide analytical CMC leadership for regulatory filings, including authoring and reviewing analytical sections for INDs and IMPDs
• Oversee the reference standard program and coordinate release testing at external laboratories
• Drive resolution of investigations, deviations, and comparability assessments
• Collaborate with Quality Assurance to manage change controls and quality event documentation

Requirements

• PhD in Biochemistry, Molecular Biology, or Chemical/Biological Engineering
• 10+ years of progressive industry experience in analytical method development, validation, and regulatory submissions
• Proven experience in functional team leadership and analytical strategy execution
• Expertise in high-throughput sequencing (NGS, RNA-seq), bioanalytical methods (ddPCR, RT-PCR, ELISA, DLS), and chromatographic techniques (LC)
• Experience managing stability studies, OOS/OOT investigations, and root cause analysis
• Demonstrated track record of successful method transfers to CROs/CDMOs
• Strong knowledge of global regulatory requirements and ICH guidelines
• Experience authoring/contributing to Module 3 for analytical methods and stability studies

Preferred Qualifications

• Experience with IND filing and answering health authority queries
• Experience with bioassay development for RNA and/or LNP-related products
• Expertise in cell-based potency assays for immunology/oncology applications