Senior Director, Analytical Development

Overview

The Senior Director of Analytical Development is accountable for providing strategic direction, technical leadership, and operational execution of analytical method development, validation, and testing strategies to support the development of Xeris' products and platforms. This is a critical role on the Product Development Technical Operations (“PDTO”) Leadership Team and requires demonstrated expertise in all aspects of analytical development while directing complex analytical projects that are essential to advancing the company's product pipeline and platform technologies. As an expert in analytical method development, validation, characterization, and regulatory compliance, this position will be responsible for providing guidance, oversight, and mentoring to a team of analytical scientists and for establishing a culture of scientific excellence, innovation, and technical rigor. This role will anticipate potential analytical challenges, help monitor the competitive landscape for analytical technologies and implement mitigation strategies to reduce program risk.

Responsibilities

• Provide strategic, operational, and technical leadership to drive the analytical development of innovative therapies. Work closely with the formulation development team to foster a culture of collaborative, innovative, and efficient product development.
• Effectively collaborate with other areas within PDTO (e.g., Manufacturing Sciences & Technology, Commercial Manufacturing, Supply Chain Logistics, CMC, etc.) and external departments within Xeris (e.g., Quality, Regulatory Affairs, Finance, etc.) as needed to support and advance project deliverables.
• Lead and manage a team of analytical scientists in the development, qualification, and validation of complex analytical methods for injectable small molecules, peptides, and proteins using state-of-the-art analytical techniques and instrumentation.
• Serve as Xeris' subject matter expert on analytical development and lead efforts to prepare and present highly technical analytical information to executive leadership, collaborators, and potential partners in a consumable format.
• Lead the development, qualification, and validation of robust analytical methods for small molecules, peptides, and proteins using advanced characterization techniques including RP-HPLC, SEC, IEX, HIC, LC-MS/MS, CE, DLS, DSC, AUC, MALS, HDX-MS, other specialized analytical instrumentation for biotherapeutic characterization.
• Develop and implement innovative analytical strategies for characterization of injectable and oral drug products, including impurity profiling, degradation product identification, subvisible particle characterization, potency assays, and stability-indicating methods.
• Lead analytical method development and optimization initiatives using Design of Experiments (DOE), and implementation of automated analytical platforms to enhance efficiency and data quality.
• Support the development of robust and scalable analytical testing strategies for injectable and oral drug products throughout the product lifecycle from early development through commercial manufacturing, including method transfer and lifecycle management.
• Identify and mitigate analytical risks associated with product development and manufacturing. Provide analytical guidance on specifications development, method validation protocols, and analytical portions of regulatory filings.
• Develop and manage analytical project budgets and timelines, ensuring efficient and on-time completion of analytical deliverables while communicating effectively with cross-functional teams.
• Cultivate partnerships by serving as lead analytical technical point of contact with contract research organizations, analytical testing laboratories, and external collaborators.
• Ensure compliance with all relevant regulatory requirements for analytical testing of injectable and oral drug products, including ICH guidelines, FDA regulations, and GMP requirements. Contribute to regulatory documentation and provide expert support during inspections and audits.
• Recruit, lead, and mentor analytical scientists to build a high performing analytical team through goal setting, mentoring, and supporting career development. Establish a culture of scientific excellence, innovation, and technical rigor.
• Write and review analytical study protocols, reports, and technical documents to support product development studies and regulatory filings. Contribute to internal training programs related to analytical science and technology.

Qualifications

• Master's degree in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related discipline with 15+ years of pharmaceutical analytical development experience, including increasing management responsibility.
• Demonstrated expertise with regulatory r