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Director, Analytical Development

Cambridge, Massachusetts, United States

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 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

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