Senior Manager, Biologic Analytics & Strategy

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

Job summary

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

You will oversee method development, validation, transfer, and product characterization while coordinating with external partners and cross-functional teams. The role requires strong expertise in ICH guidelines, regulatory submissions, and risk assessment, with a

Qualifications

• Bachelor’s degree in analytical chemistry, biochemistry, pharmaceutical sciences, chemical engineering, biology, or a related scientific discipline; an advanced degree is preferred.
• Minimum of 5 years of relevant experience in biotech/pharma.
• Experience with analytical method development, validation, and transfer for biologics.
• Experience with extended product characterization and comparability assessments for biologics.
• Hands-on experience authoring and reviewing analytical content for regulatory submissions.
• Strong knowledge of ICH guidelines and regulatory expectations for biologics.

Responsibilities

• Lead analytical method development, qualification, validation, and transfer for biologic drug substances and products.
• Design and oversee extended product characterization studies to understand product quality attributes.
• Develop analytical strategies and perform comparability assessments for process/formulation changes and tech transfers.
• Author and review analytical content for regulatory submissions and health authority responses.
• Ensure programs align with ICH guidelines and global regulatory expectations across development stages.
• Provide interpretation of analytical data, identify risks, and propose phase-appropriate solutions.
• Manage contract laboratories and external partners, including defining scope and timelines.
• Collaborate with Process Development, Formulation, Manufacturing, Quality, Regulatory Affairs, and other CMC functions.
• Contribute to continuous improvement of analytical capabilities, standards, workflows, and documentation.

Skills

Scientific writing

Data interpretation

Problem solving

Project management

Stakeholder communication

Education

Bachelor’s degree in analytical chemistry, biochemistry, pharmaceutical sciences, chemical engineering, biology, or related field

Job description

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

You will oversee method development, validation, transfer, and product characterization while coordinating with external partners and cross-functional teams. The role requires strong expertise in ICH guidelines, regulatory submissions, and risk assessment, with a