Senior Manager, Upstream MSAT

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.

Location: Princeton NJ (ONSITE)

• Provide technical support and leadership for upstream process characterization validation and commercial manufacturing support including process optimization and troubleshooting.
• Leadtechnology transfer activities across internal teams and CDMOs including scale-up PPQ execution and commercial readiness serving as the primary technical interface with external partners.
• Support clinical and commercial manufacturing by ensuring alignment with development timelines supply plans and operational readiness.
• Assess and manage process risks and lifecycle changes including risk assessments deviation investigations root cause analysis CAPA and change control.
• Author and review regulatory submissions (IND/IMPD/BLA/MAA Module 3 sections) and provide technical support for health authority interactions.
• Oversee PPQ execution and commercial manufacturing support including person-in-plant activities ensuring GMP compliance data integrity and inspection readiness (PLI/PAI).
• Lead change control activities including impact assessments and collaborate with Quality and Technical Operations on the development and execution of implementation plans.
• Drive continuous improvement initiatives to enhance process robustness scalability and operational efficiency.
• Travel as needed to support manufacturing technology transfer and CDMO oversight.

• Perform other duties as assigned.

• • • Degree in chemical engineering biotechnology pharmaceutical science or a related field.
      Bachelors degree with 8 years of relevant experience; Masters degree with 6 years of relevant experience; PhD with 3 years of relevant experience.

• Experience with CHO mammalian cell culture processes including seed train operations production bioreactors media and feed strategies process scale-up harvest clarification technology transfer and commercial manufacturing support.
• Direct experience in process scale-up and technology transfer across scales systems and manufacturing sites including transfer from development through commercial manufacturing; experience with large-scale (>10 kL) stainless steel bioreactors and centrifugation transfer is a plus.
• Demonstrated experience performing facility fit assessments including evaluation of process equipment critical raw materials utilities and manufacturing capabilities to support successful technology transfer and commercialization.
• Experience in late-stage process development characterization and validation is highly valued
• Experience authoring IND/IMPD and BLA/MAA Module 3 content as well as CPV (Continued Process Verification) is highly preferred.

• Proficiency in data analysis and statistical tools (e.g. JMP DOE multivariate analysis) to support process understanding and data-driven decision-making.
• Strong communication interpersonal and project management skills with the ability to work independently operate effectively in a matrixed environment and manage multiple priorities under tight timelines.

• Good information management and data organization skills
• Exceptional interpersonal skills with the ability towork individually within a multi-disciplinary team as well as with external partners and regulators.
• A track record of working under pressure and delivering high-quality results to tight deadlines.

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.