Associate Director, CMC Program Management

Description

This role suits someone who enjoys science and wants to help turn new research into medicines that matter to patients.

The company develops medicines that change patients' lives and moves quickly from scientific ideas to treatments, with teams that work across boundaries and question established practice.

The role is an Associate Director position, Cell Therapy CMC Project Manager, on the CMC Project Management Portfolio Strategy team within Cell Therapy Technical Operations.

The CMC project manager is the execution partner to the CMC Program Leader, who owns product-level CMC strategy. You turn cell therapy drug-product and CMC strategy into integrated, workable plans from early development through clinical development to launch.

You are responsible for the overall CMC project plan as the one reference for the program, covering scope, milestones, timelines, dependencies, risks, resources and budget. You set up the governance routine that turns strategy into delivery, spot risks early, and align process development, analytical development, manufacturing, quality, supply chain, regulatory and external partners so CMC delivery is predictable.

You also help shape CMC portfolio strategy and the operating model, improving standard ways of working, portfolio visibility, project-management skills, and use of digital and AI-enabled tools.

Responsibilities

• Turn cell therapy drug-product and CMC strategies into phase-appropriate integrated plans covering development, clinical manufacturing, regulatory deliverables, technology transfer, manufacturing network activities and commercial readiness.
• Build and maintain multi-year CMC integrated plans with milestones, critical path, dependencies, resources, budget, risks and key decision points.
• Work with CMC Program Leaders and functional experts to bring process development, analytical development, manufacturing, quality, supply chain and regulatory work into one executable CMC plan.
• Keep the plan accurate as assumptions, technical strategy, priorities or development timelines change.
• Manage changes through a consistent change-control process tied to development milestones and lifecycle management, and track jurisdictional and regulatory approval dependencies that affect CMC plans.
• Drive delivery against governance-endorsed scope, timelines, milestones, resources and budget, making sure decisions and actions are followed through and project status is visible.
• Identify cross-functional dependencies, risks, issues and schedule impacts early, work with accountable owners on mitigation and contingency plans, and escalate when needed.
• Run project-team meetings with clear agendas, decisions, actions and follow-up, focused on decisions and execution rather than administration.
• Help the CMC Program Leader route each decision to the right forum (function, CMC team, Program Steering Committee or senior leadership) with clear inform, endorse or decide guidance, using decision-ready formats of context, options, recommendation and ask, and keep a decision log with owners and follow-up.
• Prepare concise, decision-focused project updates and integrated CMC information for governance and senior leadership discussions.
• Facilitate cross-functional planning and problem-solving workshops when complex challenges need them.
• Help the CMC Program Leader pre-align communications across the Program Steering Committee, functional heads and enterprise forums so the CTTO presents one integrated position; escalate early and avoid unaligned commitments to external parties.
• Work with CMC Program Leaders, Global Program Managers, Finance and functional leaders on resource forecasting, external budget planning, allocation, maintenance and reconciliation, including assumption-based resource demand submissions and reviews of forecast against actuals.
• Provide accurate program-level information for portfolio prioritisation, resource decisions, scenario planning and trade-off discussions.
• Keep portfolio visibility consistent across schedule, milestones, risk, resources and financials.
• Support scenario planning and assess potential CMC impacts when priorities, technical assumptions, timelines or resource constraints change.
• Champion consistent, phase-appropriate CMC project-management standards, tools and ways of working across programs and functional sub-teams.
• Set up and maintain fit-for-purpose tools for planning, scheduling, RAID management, financial tracking, portfolio reporting and decision support.
• Use tools such as Microsoft Project, Smartsheet, PLANIT and related portfolio platforms to improve planning discipline, data quality and transparency.
• Apply AI-enabled project-management and productivity tools with skill and curiosity to improve planning, synthesis, reporting, risk identification and efficiency.
• Identify and implement practical process, tool, automation and AI improvements that simplify ways of working and strengthen project and portfolio visibility.
• Contribute to continuous improvement of the CMC Project Management operating model.

Requirements

• Bachelor's, Master's or PhD in a relevant scientific, engineering or technical discipline, such as biochemistry, cell biology, molecular biology, immunology, chemical engineering or a related field, or equivalent relevant industry experience.
• 10+ years of relevant experience with a BS, 5+ years with an MS, or 3+ years with a PhD.
• Experience in CMC, technical, process development, manufacturing or CMC project or program management within the biopharmaceutical industry.
• Preferred: knowledge of cell therapy CMC development, including autologous, allogeneic or in vivo approaches.
• Understanding of drug-product and process development, analytical development, clinical manufacturing, technology transfer, quality, regulatory expectations and/or supply chain in a CMC setting.
• Proven ability to lead complex cross-functional CMC projects as an execution leader rather than a tracker, turning technical strategy into integrated plans in close partnership with the CMC Program Leader.
• Solid grasp of cell therapy drug-product development and how process development, analytical development, manufacturing, quality, regulatory work and supply chain depend on each other.
• Advanced project-management skills in integrated scheduling, critical-path analysis, dependency and risk management, scenario planning, resource planning and financial management.
• Ability to spot emerging risks, challenge assumptions constructively, drive timely decisions, escalate early, and follow actions to resolution, owning overall program health as a trusted partner to the CMC Program Leader.
• Strong working knowledge of Microsoft Project, Smartsheet and/or comparable enterprise project and portfolio tools.
• Willingness and skill to adopt AI-enabled PM, automation and productivity tools to improve execution and decision support.
• Able to communicate and facilitate well, turning complex CMC information into concise, decision-ready insights for project teams and senior leaders.
• Can win over cross-functional stakeholders and align them without holding line authority over them.
• Able to work independently in a changing environment while partnering closely with CMC Program Leaders and functional teams.
• Focus on standardisation, continuous improvement, simplification and scalable ways of working.
• Preferred: project-management training or professional certification such as PMP.

Conditions

Annual base pay ranges from $136,514 to $204,771 USD, and the final figure may vary with market location, job-related knowledge, skills and experience.

Hourly and salaried non-exempt employees receive overtime pay for qualifying overtime hours.

Employment is at-will, and the company may change base pay and other discretionary pay or compensation programs at any time, including for individual or team performance and market factors.

The posting date is 29-Oct-2026 and applications close on 11-Nov-2026.

The company welcomes applications from all qualified candidates regardless of protected characteristics.

Benefits

• Short-term incentive bonus opportunity.
• Equity-based long-term incentive program for salaried roles, a retirement contribution for hourly roles, and commission eligibility for sales roles.
• Qualified 401(k) retirement plan.
• Paid vacation, holidays and leaves.
• Medical, prescription drug, dental and vision coverage under the terms of the applicable plans, with full details provided on receipt of an offer.