Principal Scientist – Analytical Development

We are seeking a Principal Scientist to fill a specialist role in Analytical Development with strong experience in the analysis of biologics to support late-stage activities, including method validations/Quality Control activities to support commercial readiness, setting and justifying specifications, process and product characterization, and preparing CMC sections in regulatory submissions (BLAs/MAAs). You will play a key role in driving analytical development strategies and managing analytical activities at multiple CROs/CDMOs. This position spans both early- and late-stage development, ensuring smooth progression from clinical manufacturing to commercial readiness. **Key Responsibilities** **Early-Stage Analytical Development** - Support early-stage biologics programs by applying phase-appropriate strategies for analytical development. - Collaborate with Drug Substance, Drug Product, Research, Quality, and Regulatory teams to align on required analytical support. - Provide technical input to CDMOs on method development and validation, setting and justifying specifications, early-stage product characterization, reference standard establishment, stability protocols, risk assessments, etc. - Author and/or review CMC sections of Phase 1/2 regulatory submissions. **Late-Stage Analytical Development** - Manage analytical method transfer, optimization, and validation efforts with external partners to support commercial readiness. - Ensure an appropriate, mechanism of action-based potency assay is in place to support Phase 3 readiness (experience with non-cell-based potency assays is a plus). - Provide analytical support and guidance for process characterization activities, including the determination of Critical Quality Attributes, and ensure methods are appropriately validated for testing In-Process Controls. - Provide technical input to CDMOs on method validations, setting and justifying specifications, comparability assessments, late-stage product characterization, reference standard establishment, stability protocols, risk assessments, etc. - Prepare CMC sections for regulatory submissions (BLAs/MAAs) with emphasis on analytical sections; if necessary, represent the company as the analytical expert in interactions with regulatory authorities, including preparation of requests and responses. **Continuous Improvement** - Monitor regulatory trends and integrate new analytical approaches. - Lead and manage the work of analytical CROs/CDMOs, material suppliers, consultants, vendors, and collaborators to support analytical activities. - Identify and execute opportunities to improve efficiency and reduce costs. - Share best practices and advise colleagues on data interpretation. **Qualifications** **Education & Experience** - Bachelor’s degree in a relevant subject (e.g. analytical chemistry, protein chemistry, chemistry, biochemistry, biotechnology, etc.) at a minimum, with a Master’s degree or Ph.D. preferred. - 7+ years of industry experience in the analysis of biologics, especially at late-stage, and a strong history of collaboration with CDMOs. **Technical Expertise** - Proven experience providing analytical support to biologics programs, especially antibodies, from first-in-human through commercialization. - Practical knowledge of phase-appropriate analytical method development and validations, product characterization, and comparability assessments - Direct experience with regulatory submissions such as BLAs/MAAs, ideally across multiple programs, especially to support late-stage biologics programs. - Solid understanding of ICH guidelines and pharmacopeias for stability and method validation expectations. - Experience with mechanism of action-based potency assays is a plus. - Experience establishing reference standards is a plus. **Skills & Competencies** - Strong project management and organizational abilities. - Excellent communication and technical writing skills for regulatory documentation. - Collaborative mindset and ability to work effectively with external partners. - Flexible, proactive, and comfortable operating in a fast-paced biotech environment at a company spread out across multiple time zones.