Director, Analytical Development

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.

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).

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

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 Module 3 for analytical methods and stability studies

Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders in a fast-paced, integrated multidisciplinary team environment

Commitment to technical excellence with a strong ability to embrace an entrepreneurial spirit

Experience with IND filing and answering queries from health authorities preferred

Experience with bioassay development for RNA and/or LNP-related products preferred

Demonstrated expertise in cell-based potency assays for immunology/oncology applications including development, qualification, validation, and lifecycle management preferred

Pay Range; $225,000 - $245,000