AD/Director Analytical Method Development

Barrington James; United States; On-site; USD 180,000 - 260,000; Full time

Job summary

Barrington James is seeking a Principal Scientist / Associate Director / Director – Analytical Methods to lead late‑stage analytical method development for biologics, including monoclonal antibodies and bispecifics. The role is hands‑on with emphasis on method design, optimization, and strategic regulatory alignment.

Key responsibilities include leading LC-MS, SEC‑HPLC, and cIEF method development, supporting regulatory submissions, and collaborating with Process Development, MSAT, Quality, and

Qualifications

• Strong background in analytical method development within biologics.
• Experience in late-stage development environments (Phase II–III / BLA).
• Hands-on development experience with LC‑MS, SEC‑HPLC, and cIEF.
• Experience with ADCs or monoclonal antibodies and/or bispecific antibodies is advantageous.

Responsibilities

• Lead and execute analytical method development for late‑stage biologics programmes.
• Develop, optimise, and troubleshoot methods including LC‑MS (intact/subunit), SEC‑HPLC, and cIEF.
• Support full analytical characterisation of monoclonal antibodies, bispecific antibodies, and other protein therapeutics.
• Design and implement analytical strategies to support late‑stage development, comparability, and regulatory submissions.
• Work closely with cross‑functional teams including Process Development, MSAT, Quality, and Regulatory functions.
• Support method transfer activities to internal and external laboratories (CROs/CDMOs).
• Contribute to analytical control strategies for late‑stage and commercial‑readiness programmes.
• Interpret complex analytical data and present findings to project teams and governance forums.
• Ensure scientific robustness and regulatory alignment of analytical methods used in clinical and late‑stage development.

Skills

Analytical method development

Late-stage development (Phase II–III)

LC‑MS

SEC‑HPLC

cIEF

Biologics characterization

Regulatory strategy support

Cross-functional collaboration

Leadership

Tools

LC‑MS instrumentation

SEC‑HPLC instrumentation

cIEF instrumentation

Job description

Principal Scientist / Associate Director / Director – Analytical Methods

(Late-Stage Biologics)

We are working with an innovative Biotech seeking a senior/director Analytical Method expert to join a high-performing team supporting late-stage antibody and protein therapeutics.

This is a hands‑on scientific role focused on analytical method development across late‑stage programmes. The position is not QC-, validation-, or CMC‑writing focused, and requires strong technical ownership of method design, optimisation, and scientific strategy.

The organisation is expanding its late‑stage capabilities across mAbs and bispecific antibodies, with additional exposure to ADC programs considered advantageous.

Key Responsibilities

• Lead and execute analytical method development for late‑stage biologics programmes
• Develop, optimise, and troubleshoot methods including LC‑MS (intact/subunit), SEC‑HPLC, and cIEF
• Support full analytical characterisation of monoclonal antibodies, bispecific antibodies, and other protein therapeutics
• Design and implement analytical strategies to support late‑stage development, comparability, and regulatory submissions
• Work closely with cross‑functional teams including Process Development, MSAT, Quality, and Regulatory functions
• Support method transfer activities to internal and external laboratories (CROs/CDMOs)
• Contribute to analytical control strategies for late‑stage and commercial‑readiness programmes
• Interpret complex analytical data and present findings to project teams and governance forums
• Ensure scientific robustness and regulatory alignment of analytical methods used in clinical and late‑stage development

Candidate Requirements

• Strong background in analytical method development within biologics
• Experience working in late‑stage development environments (Phase II–III / BLA -approval)
• Expertise in LC‑MS, SEC‑HPLC, and cIEF (hands‑on development experience essential)
• Proven experience with ADCs or monoclonal antibodies and/or bispecific antibodies
• Experience within large pharma or established biotech environments preferred
• Strong understanding of protein characterisation techniques and analytical control strategies
• ADC experience is advantageous