Sr. 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.

Overview of Role:

The Manager/Senior Manager Upstream MSAT will lead upstream process engineering activities to support commercialization of Ivonescimab. This role focuses on upstream biologics production providing technical oversight and troubleshooting across development and manufacturing. The position collaborates closely with CMC quality regulatory teams and external CDMOs to ensure successful tech transfer process readiness and delivery of CMC milestones.

Role and Responsibilities:

• Lead and support upstream process design optimization troubleshooting and tech transfer for drug substance manufacturing.
• Drive process development characterization validation and risk management across internal teams and external CDMOs.
• Collaborate cross-functionally with QA RA supply chain and CMOs; provide clear updates to project leadership.
• Contribute to regulatory documentation and support CMC programs and sub-teams.
• Support BLA filing and related activities including responding to RFIs preparing for PAI PAS submissions annual product reviews and other regulatory commitments
• Resolve upstream manufacturing issues and facilitate problem-solving and contingency planning.
• Promote continuous improvement for process robustness efficiency and scalability.
• Oversee tech transfer and manage deviations change controls and risk assessments.
• Travel as needed for tech transfer scale-up and external collaboration.
• Perform all other duties as assigned.
• All other duties as assigned

Experience Education and Specialized Knowledge and Skills:

• Bachelors degree in Engineering Biochemistry Pharmaceutical Sciences or related field; MS or PhD preferred.
• Minimum of 6 years of experience in biologics DS manufacturing with emphasis on late-phase monoclonal antibody development.
• Proven ability to design and execute Design of Experiments (DoE) studies including multivariate data analysis and interpretation to optimize process parameters and enable data-driven decisions.
• Demonstrated success in process scale-up and technology transfer from bench to pilot and commercial scale.
• Strong background in tech transfer across multiple systems scales and manufacturing sites.
• Hands-on experience in scale-down model qualification (SDMQ) process characterization (PC) validation (PV) and PPQ campaigns is strongly preferred
• Experience in authoring regulatory submissions including IND IMPD and BLA documentation is strongly preferred
• Familiarity with cell line development and media optimization is a plus
• Exceptional attention to detail organizational skills and commitment to quality and technical excellence.
• Strong interpersonal skills; able to work independently in cross-functional teams and with external partners and regulators.
• Proven ability to deliver high-quality results under pressure and tight timelines.

The pay range for this role is $168000 - $190000 annually. 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 at to obtain prior written authorization before referring any candidates to Summit.