Biologics Analytics Lead – Regulatory Strategy

Summit-Therapeutics; Princeton (NJ); On-site; USD 148,000 - 188,000; Full time

Benefits offered by this job

Analytical science support

Job summary

Summit Therapeutics Inc. in Princeton, NJ, is seeking a Senior Manager, Analytical Sciences to provide scientific leadership for analytical activities from clinical development through post-approval support.

You will oversee method development, validation, transfer, and product characterization, driving comparability assessments and regulatory submissions in a fast-paced biotech setting.

Qualifications

• Bachelor’s degree in analytical chemistry, biochemistry, pharmaceutical sciences, chemical engineering, biology, or a related scientific discipline; advanced degree preferred.
• Minimum of 5 years of relevant experience in biotech/biopharmaceutical/pharmaceutical industry.
• Experience with analytical method development, validation, and transfer for biologics.
• Experience with product characterization and comparability assessments for biologics.
• Experience authoring analytical content for regulatory submissions.
• Strong writing, data interpretation, and stakeholder communication skills.

Responsibilities

• Lead analytical method development, qualification, validation, and transfer for biologic substances and products.
• Design product characterization studies to understand quality attributes.
• Develop analytical strategies and perform comparability assessments for various changes.
• Author/regulate analytical sections of regulatory submissions and responses.
• Ensure alignment with ICH guidelines across development to post-approval stages.
• Manage external labs and vendors with clear scope and timelines.
• Collaborate with Process Development, Formulation, Manufacturing, Quality, and Regulatory teams.
• Contribute to continuous improvement of analytical capabilities and workflows.
• Demonstrate flexible, collaborative approach to changing priorities.

Skills

Analytical method development

Biologics data interpretation

Scientific writing

Problem solving

Project management

Stakeholder communication

External partner management

Education

Bachelor’s degree in analytical chemistry or related scientific discipline

Tools

ICH guidelines knowledge

Job description

Summit Therapeutics Inc. in Princeton, NJ, is seeking a Senior Manager, Analytical Sciences to provide scientific leadership for analytical activities from clinical development through post-approval support.

You will oversee method development, validation, transfer, and product characterization, driving comparability assessments and regulatory submissions in a fast-paced biotech setting.