Associate Director, LC Development, Biologics Analytical Development

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 phaseappropriate (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 phaseappropriate qualification of (U)HPLC methods (SEC IonExchange RPHPLC 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 cuttingedge LC technologies (e.g. ultrahigh 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 phaseappropriate 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 onsite training and posttransfer 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.

You will need to have :

We would prefer for you to have :

Date Posted

02-Dec-2025

Closing Date

15-Dec-2025

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.

Required Experience :

Director

Key Skills

Fundraising,Management Experience,Biotechnology,Clinical Development,Clinical Trials,Research & Development,Training & Development,Grant Writing,Economic Development,Leadership Experience,Public Speaking,Product Development

Employment Type : Full-Time

Experience : years

Vacancy : 1