Director CMC Program Lead

AstraZeneca • Gaithersburg, MD

52d • Onsite

About The Position

The Cell Therapy CMC Program Lead Director is responsible for leading cross-functional matrix teams within Cell Therapy Development & Operations on multiple projects from inception through completion, coordinating activities to develop the physical product, manufacturing process, supply chain and regulatory files. This position reports into the Head of CMC Cell Therapy Portfolio Strategy and interfaces directly with the CMC Program Steering Committee for escalations, strategic decisions, and reporting. This position is based in either Santa Monica, CA or Gaithersburg, MD.

Requirements

• 12+ years with BS/BA degree in a technical, engineering or life sciences subject area; 10+ years with MS/MA or MBA; 6+ years with PhD
• 8+ years leading cross-functional matrix teams and programs
• Must have relevant CMC knowledge on process development and manufacturing, along with a thorough solid understanding of the Biotech or Cell Therapy industry, relevant regulations, and requirements.
• Experience leading matrix teams in a regulated environment.
• Authored CMC sections of IND/NDA and / or BLA/MAA.
• Thorough understanding of the drug development process.
• Experience with technical and scientific challenges as applying the novel assays for drug product release from pre-IND to stage products.
• Willingness to occasionally travel for business purposes.

Responsibilities

• Build, grow, and mature the CMC function within Cell Therapy Development & Operations and serve as a central point of accountability for CMC portfolio execution.
• Must possess strong communication skills and must be savvy working with technology, process development, analytical development, manufacturing and business partners across the organization in a collaborative way. Demonstrates excellent stakeholder management skills with matrixed functional teams (Manufacturing, Process & Analytical Development, Quality, Regulatory, Supply Chain).
• Prepare project team and steering committee materials related to their assigned projects and ensure project work aligns with established practices, policies, and processes. Provide regular updates to senior management and key team members with program status, risks, mitigation plans, and recommendations for strategic decisions.
• Owns risk management (identification, escalation, resolution, mitigation) for all CMC activities and ensures effective resolution via collaboration, matrix leadership, and formal escalation pathways.
• Lead the strategic planning and execution of CMC programs for cell therapy products from early development through commercialization with clear transition management between early and late-stage milestones as defined by governance stage gates.
• Collaborate cross-functionally with R&D, Process & Analytical Development, Manufacturing, Quality, Regulatory Affairs, Supply Chain and other departments to drive program success and alignment with business objectives. Facilitates seamless cross-functional integration, aligning diverse technical and operational input to achieve CMC deliverables, investment decisions, and key milestones.
• Develop and lead program timelines, budgets, and resources to meet project achievements and deliverables. Coordinates and secures functional resources in partnership with functional leaders, maintains updated RACI for every stage gate, and ensures team alignment on objectives.
• Identifies and anticipates CMC-related risks/constraints to timing and resources and proactively communicates/escalates via RACI-defined channels.
• Provide strategic guidance and oversight for CMC-related regulatory submissions, including IND, BLA, and other regulatory filings. Ensures program deliverables meet regulatory and compliance requirements at each development stage; partners with regulatory experts and functional reps for aligned submissions.
• Drive continuous improvement initiatives to optimize CMC processes, systems, and workflows within the CMC Product Team and across the matrix organization.
• Develop, champion, and deliver a program-specific COGm reduction roadmap in alignment with portfolio and organizational targets, working collaboratively across functions to embed cost optimization and efficiency into all phases of CMC strategy.
• Lead and mentor a team of project manager(s) and specialists to ensure commitment, collaboration, and professional development.
• Consistently maintains a positive & professional approach in communication, [e.g. maintaining composure under pressure and leading up.] ensuring transparency, active listening, and patient-centric urgency.
• Foster strong relationships with external partners, vendors, and team members to support program goals and objectives and verifies seamless CMC process integration when working with CDMOs.
• Stay informed of industry trends, emerging technologies, and regulatory developments in cell therapy CMC to advise program strategies and decisions. Translate trends and learnings into actionable recommendations for the matrix team and portfolio.
• Drive continuous improvement initiatives within the CMC Portfolio Strategy function to enhance efficiency, productivity, and quality. Cultivates best practices in matrix ways of working, governance discipline, and stakeholder engagement.
• Advises program communications and ensures that all program customers are fully informed and knowledgeable of program activities and their status. Maintains transparent upward and lateral communication, shares rationale for decisions, and closes feedback loops with all stakeholders.
• Collaborates with functional leaders to ensure that functional area resources are sufficient to achieve project goals and objectives. Partners with functional representatives and leaders, ensures matrix contributions are visible, valued, and proactively managed.
• Promote a culture of collaboration, cooperation, cross functional inclusion, execution excellence, effective communication and cross-functional problem-solving to become a successful team. Models and sponsors AZ core values in all aspects of team engagement, especially matrix accountability and patient-first urgency.
• Provides leadership to the CMC program team and functional areas to anticipate and identify sophisticated program issues, which pose a challenge to achieving strategic goals. Implements plan to resolve such issues and completes corrective actions. Leads formal issue escalation and resolution in partnership with the matrix team and Program Steering Committee, as required.
• Selects, evaluates and supports the development of direct reports and fosters development and recognition of high-performing members of the extended matrix team.

Benefits

• A qualified retirement program [401(k) plan]
• Paid vacation, holidays, and paid leaves
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees