Stylus Medicine
Director, Analytical Development
Cambridge, Massachusetts, United States · Director
Sponsorship not specified$225k-$245kDetected 58 days ago
FDA RegulatoryPCRMolecular BiologyNGSProtein AnalysisAnimal StudiesLeadershipCommunication
About the role
- Stylus Medicine is seeking a Director of Analytical Development to provide strategic and technical leadership for analytical development within our portfolio.
- Interpret and apply global regulatory guidelines (e.g., ICH, FDA) to assay development and lifecycle activities
- Act as a company liaison with contract laboratories, coordinating method transfers and overseeing method qualification and validation activities
Responsibilities
- 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
- Define and drive potency assay strategy, aligning with product mechanism of action, CQA frameworks, and regulatory expectations
- Drive resolution of investigations, deviations, and comparability assessments
- Collaborate with Quality Assurance to review and manage change controls and quality event documentation
- Partner cross-functionally to support data-driven decision-making and operational excellence
Requirements
- Experience managing stability studies, protocol development and performing trending analysis, OOS/OOT investigations, root cause analysis, etc.
- 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
- 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
- Attention to detail and accuracy in developing and reviewing SOPs, batch records and technology transfer documents
- 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
Nice to have
- Demonstrated expertise in cell-based potency assays for immunology/oncology applications including development, qualification, validation, and lifecycle management preferred
Skills
- Proven experience as a functional leader, including team leadership and accountability for analytical strategy execution
- Demonstrated track record of successful method transfers to CROs/CDMOs
- 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
- 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
- Pay Range; $225,000 - $245,000
Compensation
- Pay Range; $225,000 - $245,000
Company info
- 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.
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