Senior Manager, Analytical Sciences – Biologics (Princeton)

Summit Therapeutics, Inc.; Princeton (NJ); Sur place; USD 148 000 - 188 000; Plein temps

Résumé du poste

Summit Therapeutics Inc. in Princeton, NJ seeks a Senior Manager, Analytical Sciences to lead analytical development for biologics from clinical development through post-approval.

You will shape strategies, oversee method development, validation, transfer, and product characterization while coordinating with external partners. The role requires a strong ICH knowledge base, technical leadership, and effective cross-functional collaboration to support regulatory submissions and lifecycle

Qualifications

• Bachelors degree in a relevant scientific discipline; an advanced degree preferred.
• Minimum 5 years in biotech, biopharma, or pharmaceutical industry.
• Experience with analytical method development, validation, and transfer for biologics.
• Experience with extended product characterization and comparability assessments for biologics.
• Strong scientific writing and regulatory submission experience.
• Vendor/ CRO management experience.

Responsabilités

• 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 conduct comparability assessments for process, formulation, and tech transfers.
• Write and review analytical sections of regulatory submissions and responses to health authorities.
• Manage contract labs and external partners, defining scope and timelines.
• Collaborate across Process Development, Formulation, Manufacturing, Quality, and Regulatory along with CMC teams.

Connaissances

Analytical method development

Regulatory submissions

ICH guidelines

Data interpretation

Project management

External partner management

Formation

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

Description du poste

Summit Therapeutics Inc. in Princeton, NJ seeks a Senior Manager, Analytical Sciences to lead analytical development for biologics from clinical development through post-approval.

You will shape strategies, oversee method development, validation, transfer, and product characterization while coordinating with external partners. The role requires a strong ICH knowledge base, technical leadership, and effective cross-functional collaboration to support regulatory submissions and lifecycle