Senior Manager, Analytical Sciences

About Summit:

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. Summits 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.

Summits team is inspired to touch and help change lives through Summits 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.

Colorectal Cancer (CRC)

• 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 Chinas 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

Location: Princeton New Jersey

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.

• 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.

• Bachelors 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 companys 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.

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 Summits Talent Acquisition team atto obtain prior written authorization before referring any candidates to Summit.

Summit Therapeutics 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.