Associate Director, LC Development, Biologics Analytical Development

AstraZeneca•New Haven, CT

About The Position

This is what you will do: The Associate Director, LC Development will lead the development, optimization, transfer, and lifecycle management of liquid chromatography-based methods supporting biologics programs across clinical and commercial phases. This role will oversee a team responsible for release and stability test method development targeting key quality attributes of therapeutic proteins, including size variants, charge variants, hydrophobic variants, fragmentation, excipient analysis and process additives, using phase‑appropriate (U)HPLC modalities (SEC, IEX, RP-HPLC, HIC, and related). The position will partner closely with Quality Control, Process Development, Manufacturing, Quality Assurance, Clinical Stability, and Analytical Technical Transfer Services (ATTS) to ensure robust method performance, successful transfers/validations, and cGMP readiness. The Associate Director will establish technical strategies, introduce new technologies to enhance throughput and capability, and serve as a key technical lead during audits, investigations, and regulatory interactions. You will be responsible for: LC Strategy and Leadership: Define LC method development strategy and roadmap for biologics quality attributes; prioritize portfolio activities and allocate resources across programs and phases. Method Development and Optimization: Lead development, optimization, and phase‑appropriate qualification of (U)HPLC methods (SEC, Ion‑Exchange, RP‑HPLC, HIC, peptide mapping) for monoclonal antibodies, fusion proteins, enzymes, and glycoproteins; ensure suitability for release, stability, characterization, and comparability. Instrument Ownership and Operations: Oversee operation, maintenance, and troubleshooting of LC platforms and detectors (UPLC/HPLC, UV/Vis, fluorescence, ELSD, QDA interfaces where applicable). Technology Enablement: Evaluate and implement cutting‑edge LC technologies (e.g., ultra‑high resolution columns, mix-mode columns, 2D separation, native and denatured SEC/IEX workflows, automated sample prep, informatics tools) to improve throughput, robustness, and data quality. Documentation and Compliance: Author and/or approve SOPs, study plans, protocols, method development reports, and phase‑appropriate validation/qualification documents; contribute to CMC sections and responses to regulatory inquiries. Transfer and Validation: Partner with ATTS and QC to design and execute method transfer and validation protocols; provide on‑site training and post‑transfer support to internal labs and CRO/CMOs; lead troubleshooting of method performance issues. Trend Monitoring and Lifecycle Management: Establish systems for trending, statistical analysis, and continuous improvement of LC assay performance across sites; lead investigations for aberrant trends/results, invalid assays, and special studies. Cross‑Functional Collaboration: Provide the LC technical lead role for assay CMC, transfers, and process validation support, working with Analytical Development and Quality Control, Process Development, Manufacturing, Technical Services, and QA. Audit and Inspection Readiness: Represent LC Development during internal/external audits; ensure methods, records, validations, and training remain compliant with current cGMP expectations. People Leadership and Development: Manage and mentor technical staff; set performance objectives and development plans; build capabilities in LC method development, troubleshooting, and data integrity. External Partnership Management: Provide technical guidance to CRO/CMO analytical activities, ensuring timely completion of protocols, reports, and method documents; maintain strong relationships with external partners.

Requirements

Education: A master’s or Ph.D. in Analytical Chemistry, Biochemistry, Chemical Engineering, or related discipline.
Experience: Minimum 10 years in pharmaceutical/biotechnology analytical development with deep expertise in protein/peptide separations by liquid chromatography (U)HPLC and at least 5 years of people/project management.
Technical Expertise: Demonstrated proficiency in developing and qualifying LC methods for biologics (SEC, IEX, RP‑HPLC, HIC, peptide mapping) and practical knowledge of protein characterization for monoclonal antibodies and glycoproteins.
Troubleshooting: Excellent troubleshooting skills in LC; experience with troubleshooting methods throughout lifecycle, in support of GMP investigations.
Communication and Collaboration: Excellent written and verbal communication; proven ability to work effectively in cross‑functional teams and represent company interests to external parties.
Tools: High proficiency with MS Office (Word, Excel, Outlook, Visio, PowerPoint) and chromatography data systems/informatics.
Travel: Domestic and international travel up to ~10–20% to support transfers, audits, and on-site troubleshooting/training.
Work Environment: Role conducted in laboratory and pharmaceutical manufacturing environments. With or without accommodation, must be able to: lift/carry 30 pounds unassisted; work in controlled environments with biological and hazardous materials; gown/degown PPE and uniforms; use a computer; engage in phone/video/electronic communications; stand/walk for prolonged periods where required; collaborate cross functionally; maintain availability during standard business hours.

Nice To Haves

cGMP and Quality: Strong knowledge of cGMP, data integrity, phase‑appropriate validation and transfer approaches, and readiness for QC deployment.
Statistical Analysis: Experience with trending and statistical analysis tools for method performance monitoring
Regulatory Familiarity: Experience contributing to CMC documentation and addressing regulatory questions related to analytical methods.

Responsibilities

LC Strategy and Leadership: Define LC method development strategy and roadmap for biologics quality attributes; prioritize portfolio activities and allocate resources across programs and phases.
Method Development and Optimization: Lead development, optimization, and phase‑appropriate qualification of (U)HPLC methods (SEC, Ion‑Exchange, RP‑HPLC, HIC, peptide mapping) for monoclonal antibodies, fusion proteins, enzymes, and glycoproteins; ensure suitability for release, stability, characterization, and comparability.
Instrument Ownership and Operations: Oversee operation, maintenance, and troubleshooting of LC platforms and detectors (UPLC/HPLC, UV/Vis, fluorescence, ELSD, QDA interfaces where applicable).
Technology Enablement: Evaluate and implement cutting‑edge LC technologies (e.g., ultra‑high resolution columns, mix-mode columns, 2D separation, native and denatured SEC/IEX workflows, automated sample prep, informatics tools) to improve throughput, robustness, and data quality.
Documentation and Compliance: Author and/or approve SOPs, study plans, protocols, method development reports, and phase‑appropriate validation/qualification documents; contribute to CMC sections and responses to regulatory inquiries.
Transfer and Validation: Partner with ATTS and QC to design and execute method transfer and validation protocols; provide on‑site training and post‑transfer support to internal labs and CRO/CMOs; lead troubleshooting of method performance issues.
Trend Monitoring and Lifecycle Management: Establish systems for trending, statistical analysis, and continuous improvement of LC assay performance across sites; lead investigations for aberrant trends/results, invalid assays, and special studies.
Cross‑Functional Collaboration: Provide the LC technical lead role for assay CMC, transfers, and process validation support, working with Analytical Development and Quality Control, Process Development, Manufacturing, Technical Services, and QA.
Audit and Inspection Readiness: Represent LC Development during internal/external audits; ensure methods, records, validations, and training remain compliant with current cGMP expectations.
People Leadership and Development: Manage and mentor technical staff; set performance objectives and development plans; build capabilities in LC method development, troubleshooting, and data integrity.
External Partnership Management: Provide technical guidance to CRO/CMO analytical activities, ensuring timely completion of protocols, reports, and method documents; maintain strong relationships with external partners.