Senior Manager, Analytical Sciences

Summit Therapeutics; Princeton (NJ); Vor Ort; USD 148.000 - 188.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Scientific writing

Data interpretation

Problem solving

Project management

Stakeholder communication

Ausbildung

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

Jobbeschreibung

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:

Non-small Cell Lung Cancer (NSCLC)

HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.

HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Senior Manager, Analytical Sciences

Position Summary

The Senior Manager, Analytical Sciences will provide scientific and technical leadership for analytical activities supporting biologic products from clinical development through post-approval support. This role is responsible for advancing robust analytical strategies, overseeing method development, validation, and transfer, and contributing to product characterization, comparability assessments, and regulatory submissions. The successful candidate will combine strong technical expertise with effective external partner management, sound judgment, and a flexible, hands-on approach in a dynamic development environment.

Key Responsibilities

• Lead analytical method development, qualification, validation, and transfer activities 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 changes, manufacturing changes, 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.
• Provide scientific interpretation of analytical data, 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 cross-functionally 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.
• Demonstrate a flexible, collaborative, and can-do attitude while responding effectively to changing priorities and business needs.

Required 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 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.
• This position is based at the company’s Princeton, New Jersey site.
• Ability and willingness to work outside standard business hours when needed to support critical activities and global business needs.
• Ability and willingness to travel for business, including visits to external partners and manufacturing or laboratory sites.

This is the pay for this position

Pay Transparency

$148,000 - $188,000 USD

Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at [e-mail] to obtain prior written authorization before referring any candidates to Summit.

Summit Therapeutics Inc.is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.