Associate Director, CMC Program Management

• Translate cell therapy drug-product and CMC development strategies into integrated, phase-appropriate project plans covering development, clinical manufacturing, regulatory deliverables, technology transfer, manufacturing network activities, and commercialization readiness.
• Develop and maintain multi-year CMC integrated plans, including milestones, critical path, dependencies, resources, budget, risks, and key decision points.
• Partner with CMC Program Leaders and functional experts to connect process development, analytical development, manufacturing, quality, supply chain, and regulatory activities into a single executable CMC plan.
• Maintain plan integrity as program assumptions, technical strategy, priorities, or development timelines evolve.
• Manage program changes through a consistent change-control process linked to development milestones and lifecycle management, and track jurisdictional and regulatory-approval dependencies that affect CMC plans.

• Drive execution against governance-endorsed scope, timelines, milestones, resources, and budget; maintain the project plan as the single source of truth and ensure follow-through on decisions and actions, with transparent visibility of project status and performance.
• Proactively identify cross-functional dependencies, risks, issues, and schedule impacts; partner with accountable owners to define mitigation and contingency plans and escalate when required.
• Lead effective CMC project-team operating rhythms, including agendas, decisions, actions and follow-up, with a focus on decision-making and execution rather than administration.
• Support the CMC Program Leader in routing each decision to the appropriate forum (function, CMC team, Program Steering Committee, or senior leadership) with clear inform, endorse, or decide guidance, using decision-ready formats (context, options, recommendation, and ask), and maintain a decision log with owners and follow-up.
• Prepare clear, decision-focused project updates and integrated CMC information for governance and senior leadership discussions.
• Facilitate cross-functional planning and problem-solving workshops when required to resolve complex project challenges.
• Support the CMC Program Leader in pre-aligning program communications across the Program Steering Committee, functional heads, and enterprise forums so that CTTO presents one integrated position; escalate early and avoid unaligned commitments to external parties.

• Partner with CMC Program Leaders, Global Program Managers, Finance partners, and functional leaders to support resource forecasting, external budget planning, allocation, maintenance, and reconciliation, including assumption-based resource demand submissions and review of forecast versus actuals to improve the realism of resource planning.
• Provide accurate program-level information to enable portfolio prioritization, resource decisions, scenario planning, and trade-off discussions.
• Maintain consistent portfolio visibility across schedule, milestones, risk, resources, and financials.
• Support scenario planning and assessment of potential CMC impacts when program 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.
• Establish and maintain fit-for-purpose project-management tools for planning, scheduling, RAID management, financial tracking, portfolio reporting, and decision support.
• Apply tools such as Microsoft Project, Smartsheet, PLANIT and related portfolio/project-management platforms to improve planning discipline, data quality and transparency.
• Demonstrate proficiency and curiosity in the application of AI-enabled project-management and productivity tools to improve planning, synthesis, reporting, risk identification, and PM 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 and evolution of the CMC Project Management operating model.

• 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.
• Demonstrated experience in CMC, technical development, process development, manufacturing, or CMC project/program management within the biopharmaceutical industry.
• Knowledge of cell therapy CMC development, preferably including autologous, allogeneic, or in vivo approaches.
• Understanding of drug-product/process development, analytical development, clinical manufacturing, technology transfer, quality, regulatory expectations, and/or supply chain within a CMC environment.

• Demonstrated ability to lead complex, cross-functional CMC projects as an execution leader rather than a project tracker, translating technical strategy into actionable, integrated execution plans in close partnership with the CMC Program Leader.
• Strong understanding of CMC drug-product development and the interdependencies among process development, analytical development, manufacturing, quality, regulatory activities, and supply chain.
• Advanced project-management capability across integrated scheduling, critical-path analysis, dependency management, risk management, scenario planning, resource planning, and financial management.
• Ability to identify emerging risks, challenge assumptions constructively, facilitate timely decisions, escalate early, and drive actions through resolution, taking ownership of overall program health and acting as a trusted partner to the CMC Program Leader.
• Strong capability in Microsoft Project, Smartsheet and/or comparable enterprise project- and portfolio-management tools.
• Proficiency and willingness to adopt AI-enabled PM, automation, and productivity tools to improve project execution and decision support.
• Strong communication and facilitation skills, with the ability to translate complex CMC information into clear, concise, decision-oriented insights for project teams and senior leaders.
• Demonstrated ability to influence and align cross-functional stakeholders without direct authority.
• Ability to operate independently in a dynamic environment while maintaining strong partnership with CMC Program Leaders and functional teams.
• Strong focus on standardization, continuous improvement, simplification, and scalable ways of working.
• Project-management training or professional certification such as PMP is preferred.

The annual base pay for this position ranges from $136,514 - $204,771 USD. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

29-Oct-2026