Senior CMC Project Manager; Biologics

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Ivonescimab, known as SMT
112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.

Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials:

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).

HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.

The Senior CMC Project Manager (Biologics) is an individual contributor position that will play a critical role driving the success of Summit programs and with prioritized focus in CMC, Supply, Quality and Business activities. This role requires a strong technical foundation in analytical development, drug product manufacturing, process validation (PPQ), and supply chain strategy, as well as proven experience managing external CDMOs and internal stakeholders in a matrixed environment.

Role requires flexible, execution-focused capabilities with the ability to take on additional responsibilities as the department/company grow.

If you enjoy the excitement and intensity of senior leader engagements where assignments may deeply embed you with targeted functions or teams, then this is the role for you!

Cross-functional Collaboration and CMC Leadership

Orchestrate CMC matrix teams (PD, AD, DP, MSAT, QA/QC, RA CMC, Supply Chain) across functions to deliver integrated project plans, timelines, and ensure milestone achievement.

Build and maintain critical path roadmaps, scenarios, and resource/load views; ensure robust change control and decision logs.

Prepare high-impact presentations, decision memos, and status reports for senior management and governance forums

Can quickly build strong and sustaining relationships with stakeholders at all levels

Translate technical CMC topics into clear business impacts and options; enable fast, informed decisions.

Implement and refine program tools, workflows, and processes to enhance efficiency, transparency, and quality of CMC operations

Ensure alignment of CMC strategy for early stage IND/IMPD and late-stage biologics suitable for BLA/ MAA filings (including characterization, control strategy, comparability, stability, regulatory expectations)

Ensure alignment of CMC deliverables with program milestones and product target profile through data-driven and risk-based decision-making

Engage in cross-functional governance and steering committees to influence and guide program direction.

Drive development, execution, and oversight of CMC strategies, including analytical method development and validation, drug substance and drug product process development, technology transfer, and process performance…