Associate Director/Director, Analytical Development and Validation, Tech Ops – Biologics

Role Overview

• Lead late-stage analytical development activities for biologics, including method validation, method qualification, and method transfer for release, stability, characterization and device functional testing assays.
• Provide subject matter expertise for ICH Q2/Q14, USP/EP/JP, and global regulatory expectations related to analytical methods.
• Oversee validation of assays including potency/bioassays, purity and impurities (SEC, CE-SDS, icIEF, HPLC), identity, characterization, residuals and device functional testing.
• Experience with PFS and Autoinjector functional testing is required, including validation per ISO guidance(s).
• Drive analytical strategies to support BLA/MAA submissions, post-approval changes, and comparability studies.
• Partner with Process Development, Manufacturing, Quality, and Regulatory to support late-stage development, tech transfer, and commercial launch readiness.
• Support analytical risk assessments, control strategy development, and lifecycle management
• Serve as analytical lead for regulatory interactions, including agency questions and inspections.
• Build, mentor, and lead a high-performing analytical development team (internal and/or external)
• Set technical direction, priorities, and timelines for late-stage analytical
• Manage and provide technical oversight to CDMOs and contract
• Review and approve protocols, validation reports, development reports, and regulatory

Requirements

• Experience with monoclonal antibodies and PFS/Auto Injectors is a
• Associate Director: Master’s (7+ years) or PhD (5+ years) with experience in a scientific discipline with relevant experience in analytical development and/or QC.
• Director: Master’s (10+ years) or PhD (7+ years) with experience in a scientific discipline with relevant experience in analytical development and/or QC.
• Relevant industry experience in method development, qualification, validation and method transfer in support of ongoing development and/or commercialization of biologics.
• Experience with methods including but not limited to U/HPLC, Capillary Electrophoresis, Spectrophotometer, Bioassay (ELISA and Cell-Based), device functional testing per ISO
• Deep understanding of ICH guidelines for method development/qualification and validation as well as regulatory expectations in US, Canada and EU.
• Experience managing multiple stability studies, protocol development and performing trending analysis, OOS/OOT investigations, root cause analysis, etc.
• Experience with late-phase comparability studies, especially geared toward
• Experience in authoring/contributing to regulatory filings, specifically Module 3 for analytical methods and stability studies
• Demonstrated track record of successful tech transfers between CDMOs with an eye towards late-stage development and commercial launch.
• Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders.
• Must have a creative and strategic attitude with the ability to work in a fast-paced

Benefits

• Competitive salary and benefits package.
• Opportunities for professional growth and development.