Director, Analytical Development

Description

Welcome to an inspired career.

At Halozyme, we are reinventing the patient experience and building the future of drug delivery. We are passionate about the important work we do and constantly strive to do more. We embrace transformation and work hard to innovate for the future. We do this together, as One Team – we rise by lifting others up and believe in the power of working together for the collective win.

That’s why we need you—to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo, advancing our mission and making our One Team culture thrive.

and you’ll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people’s lives.

The Director, Biochemistry and Microbiology, will lead Analytical Development activities supporting the characterization, method development, qualification, transfer, and release testing of Hypercon drug products and in-process samples. This role provides scientific and people leadership for a multidisciplinary team, partners cross-functionally to advance product development goals, and ensures analytical strategies are phase-appropriate, scientifically rigorous, and aligned with applicable regulatory expectations.

• Lead the development, qualification, transfer, troubleshooting, and lifecycle management of phase-appropriate analytical methods for characterization, in-process testing, and release testing of Hypercon drug products.
• Set technical strategy for assays addressing product purity, impurity profiling, microbiological quality, excipient quantification and other critical quality attributes, leveraging relevant experience, regulatory guidance, and Quality-by-Design principles.
• Lead, develop, and manage a multidisciplinary technical team, including resource planning, prioritization, mentoring, performance development, and continuous improvement of team effectiveness.
• Plan, execute, document, analyze, and interpret experiments, and communicate results and recommendations clearly to multidisciplinary and cross-functional teams.
• Provide technical leadership to resolve scientific and operational issues within the team and contribute to problem solving across Analytical Development and other technical functions.
• Author and review SOPs, method and instrument qualification protocols, technical reports, certificates of analysis/testing, and CMC sections of regulatory filings.
• Oversee interactions with partners and contract research organizations to support method transfer, method qualification, troubleshooting, data review, and delivery of high-quality analytical results.
• Serve as a subject‑matter expert for investigations of out‑of‑specification and out‑of‑trend analytical results, including root‑cause analysis, corrective actions, and data trending.
• Collaborate with Analytical Development leaders and cross‑functional partners to ensure analytical methods and testing strategies are aligned with product development goals and program timelines.
• Maintain current knowledge of industry trends, emerging analytical technologies, and applicable regulatory requirements.
• Maintain safe laboratory working conditions and ensure adherence to applicable environmental, health, and safety guidelines.
• Experience or technical knowledge across a broad spectrum of biologic modalities.
• Experience with additional analytical techniques such as GC, density measurements, and general biophysical characterization techniques.
• Working knowledge of LIMS, Empower, electronic laboratory notebooks, and data trending tools.
• Ability to recognize emerging technical risks, anticipate issues within or outside Analytical Development, and propose practical analytical solutions.
• Experience mentoring technical staff at multiple levels within and outside of own team.

• PhD preferred in Analytical Chemistry, Physical Chemistry, Materials Science, Biochemistry, Microbiology, Pharmaceutical Sciences, or a related field, with a…