Senior Manager, Analytical Sciences

Summit Therapeutics•Princeton, NJ

8d•$148,000 - $188,000•Onsite

About The Position

The Senior Manager, Analytical Sciences provides scientific and technical leadership for analytical activities supporting biologic products from clinical development through post-approval support. The role advances analytical strategies, oversees method development, validation, and transfer, and contributes to product characterization, comparability assessments, and regulatory submissions. It calls for strong technical expertise, effective external partner management, sound judgment, and a flexible, hands-on approach in a dynamic development environment. The position is based at Summit Therapeutics’ Princeton, New Jersey site. The employee must be able and willing to work outside standard business hours when needed to support critical activities and global business needs, and to travel for business, including visits to external partners and manufacturing or laboratory sites.

Requirements

Bachelor’s degree in analytical chemistry, biochemistry, pharmaceutical sciences, chemical engineering, biology, or a related scientific discipline.
At least 5 years of relevant experience in the biotechnology, biopharmaceutical, or pharmaceutical industry.
Demonstrated experience with analytical method development, validation, and transfer for biologics.
Experience with extended product characterization and comparability assessments for biologic products.
Hands-on experience authoring and reviewing analytical content for regulatory submissions.
Strong knowledge of relevant ICH guidelines and regulatory expectations for biologics from preclinical development through post-approval support.
Proven experience managing external laboratories, vendors, or development and manufacturing partners.
Strong scientific writing, data interpretation, problem-solving, project management, and stakeholder communication skills.
Ability and willingness to work outside standard business hours when needed.
Ability and willingness to travel for business, including visits to external partners and manufacturing or laboratory sites.

Nice To Haves

An advanced degree in a relevant scientific discipline.

Responsibilities

Lead analytical method development, qualification, validation, and transfer for biologic drug substances and drug products.
Design and oversee extended product characterization studies to establish a comprehensive understanding of product quality attributes.
Develop analytical strategies and execute comparability assessments supporting process, manufacturing, and formulation changes, technology transfers, and product lifecycle activities.
Author and critically review analytical sections of regulatory submissions and responses to health authority questions.
Ensure analytical programs align with relevant ICH guidelines and global regulatory expectations across preclinical, clinical, registration, and post-approval stages.
Interpret analytical data scientifically, identify risks, and recommend practical, phase-appropriate solutions.
Manage contract laboratories, contract development and manufacturing organizations, and other external partners, including defining scope, monitoring timelines and deliverables, reviewing technical work, and resolving issues.
Partner with Process Development, Formulation, Manufacturing, Quality, Regulatory Affairs, and other CMC functions to deliver integrated development plans.
Contribute to continuous improvement of analytical capabilities, technical standards, workflows, and documentation practices.
Respond effectively to changing priorities and business needs with a flexible, collaborative, can-do attitude.