Director CMC Program Lead

Position Summary
The Cell Therapy CMC Program Lead Directoris responsible forleading cross-functional matrix teams within Cell Therapy Development & Operations on multiple projects frominceptionthrough completion coordinating activities to develop the physical product manufacturing process supplychainand regulatory files. This position reports into the Head of CMC Cell Therapy Portfolio Strategy and interfaces directly with the CMCProgramSteering Committee for escalations strategic decisions and reporting. This position is based in either Santa Monica CA or Gaithersburg MD.

Responsibilities

• Build grow and mature the CMC function within Cell Therapy Development & Operations and serve asa central pointof accountability for CMC portfolio execution.

• Mustpossessstrong communicationskills and must be savvy working with technology process development analytical developmentmanufacturingand business partners across the organization in a collaborative way. Demonstrates excellent stakeholder management skills with matrixed functional teams (ManufacturingProcess & 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 tosenior managementand key team memberswith program status risks mitigation plans and recommendations for strategic decisions.

• Owns risk management (identification escalationresolutionmitigation) 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 andlate-stagemilestones as defined by governance stage gates.

• Collaboratecross-functionally with R&DProcess & Analytical DevelopmentManufacturing Quality Regulatory AffairsSupplyChainand other departments to drive program success and alignment with businessobjectives. 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 leadersmaintainsupdated RACI for every stage gate and ensures team alignment onobjectives.

• IdentifiesandanticipatesCMC-related risks/constraints to timing and resources and proactively communicates/escalates via RACI-defined channels.

• Providestrategic guidance and oversight for CMC-related regulatory submissions including IND BLA and other regulatory filings.Ensuresprogram deliverables meet regulatory and compliance requirements at each development stage; partners with regulatory experts and functional reps for aligned submissions.

• Drive continuous improvement initiatives tooptimizeCMC processes systems and workflows within the CMC Product Team and across the matrix organization.

• Develop champion and deliver a program-specificCOGmreduction 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.

• Consistentlymaintainsa positive & professional approach in communication e.g.maintainingcomposure 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 andobjectivesandverifiesseamless CMC process integration when working with CDMOs.

• Stay informed of industry trends emerging technologies and regulatory developments in cell therapy CMC toadviseprogram strategies and decisions. Translate trends and learnings into actionable recommendations for the matrix team and portfolio.

• Drive continuous improvement initiatives within the CMCPortfolio Strategyfunction to enhance efficiency productivity and quality. Cultivates best practices in matrix ways of working governance discipline and stakeholder engagement.

• Advisesprogramcommunications and ensures that allprogramcustomers are fully informed and knowledgeable ofprogramactivities 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 andobjectives. Partners with functional representatives and leadersensuresmatrix 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.

Supervisory Responsibilities

• Provides leadership to theCMC programteam and functional areas toanticipateandidentifysophisticatedprogramissues which pose a challenge to achieving strategic goals. Implements plan to resolve such issues andcompletescorrective actions. Leads formalissueescalation and resolution in partnership with the matrix team andProgramSteering Committeeas.

• Selectsevaluatesand supports the development of direct reports and fosters development and recognition of high-performing members of the extended matrix team.

Education and Experience

• 12 years with BS/BA degree in a technical engineering or life sciences subject area; 10years with MS/MA or MBA; 6 years with PhD

• 8 years leading cross-functional matrix teams and programs

• Must have relevant CMC knowledge onprocessdevelopmentand manufacturingalong 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 ofIND/NDA and / orBLA/MAA.

• Thorough understanding of the drug development process.

• Experience with technical and scientific challenges as applyingthe novelassays for drug product release from pre-IND to stage products.

• Willingness to occasionally travel for business purposes.