Associate Director, CMC​/Quality Project Management; Biologics

Associate Director, CMC/Quality Project Management (Biologics)

The pay range for this role is $153,000-$180,000 annually.

Ivonescimab, known as SMT
112, is a novel, potential first‑in‑class investigational bispecific antibody combining the effects of immunotherapy via PD‑1 blockade with the anti‑angiogenesis effects of VEGF inhibition. It currently supports three Phase III trials in non‑small cell lung cancer (NSCLC), including HARMONi, HARMONi‑3, and HARMONi‑7. Ivonescimab is not yet approved by the FDA or EMA but was granted Fast Track designation for the HARMONi clinical trial setting.

The Associate Director, Project Management (CMC, Quality) is an individual contributor who will drive success of Summit programs with a prioritised focus in CMC, Supply, Quality, and Business activities. This role will provide CMC/Quality program leadership in cross‑functional team settings and help build the infrastructure, tools and processes that contribute to the success of the Program Management department. The Associate Director will provide strategic and operational leadership for CMC and Quality deliverables across the biologics development lifecycle—from early clinical phases through BLA submission and post‑approval changes.

• Cross‑functional Collaboration and CMC Leadership:
  Represent the Program Management department in cross‑functional teams with clinical development, non‑clinical and regulatory focus.
• Integrate analytical development/Quality Control (QC), drug product development and manufacturing, and end‑to‑end supply chain to ensure robust control strategies, inspection readiness, and reliable supply.
• Develop and maintain detailed CMC submission plans, timelines, and risk mitigation strategies for BLA and other regulatory filings.
• Prepare high‑impact presentations, decision memos, and status reports for senior management and governance forums.
• Build strong and sustaining relationships with stakeholders at all levels.
• Lead key activities or assigned projects that may rapidly evolve based on business needs.
• Implement and refine program tools, workflows, and processes to enhance efficiency, transparency, and quality of CMC operations.
• Ensure alignment in 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 project 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.
• Monitor global regulatory trends (FDA, EMA, PMDA, ICH) to anticipate changes and manage compliance strategies in submissions.
• Maintain decision‑quality approaches within assigned areas with options and trade‑off assessments.
• Actively identify, track, and mitigate risks, including opportunity creation that may accelerate project success.
• Develop, implement and maintain CMC plans for assigned activities, including scenario planning, dashboards, reports and timelines that integrate into overall Program Plans; communicate these plans to cross‑functional team and leadership.
• Lead assigned internal and external communications outputs.
• Serve as the primary CMC PM interface for CDMOs/CMOs performing drug substance, drug product, and analytical testing.
• Monitor CDMO performance against KPIs (batch production and release, deviation closure, CAPA effectiveness) and escalate risks proactively.
• Drive method transfer, tech transfer, and validation activities at CDMOs to meet regulatory and program timelines.
• Support audit readiness and participate in vendor audits as needed.
• Limited travel may be required; ability to travel globally (including EU and Chinese visa requirements) may be needed for virtual meetings in different time zones.
• All other duties as assigned.

• Education:
  
  Bachelor’s degree in life sciences, chemistry, engineering, or related field required; advanced degree (MS, Pharm
  
  D, PhD, MBA) desirable.
• Experience:
  
  Minimum of 8+ years in the…