Alexion Pharmaceuticals, Inc. · 10 hours ago
Director Cell Therapy CMC Program Lead - Late Stage
Santa Monica, California, United States of America
Full-time
Hybrid
Director/Executive
$172K/yr - $259K/yr
8+ years expAlexion Pharmaceuticals, Inc. is committed to exploring and innovating within the field of Oncology R&D. The Cell Therapy CMC Program Lead Director is responsible for leading cross-functional matrix teams in the development and execution of CMC programs for cell therapy products, ensuring alignment with business objectives and regulatory requirements.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Build, grow, and mature the CMC function within Technical Operations
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
Prepare project team and steering committee materials related to their assigned projects and ensure project work aligns with established practices, policies, and processes
Project issues and risks must be identified and supervised and plans to resolve these issues must be developed and solutions implemented
Lead the strategic planning and execution of CMC programs for cell therapy products from early development through commercialization
Collaborate cross-functionally with R&D, Manufacturing, Quality, Regulatory Affairs, and other departments to drive program success and alignment with business objectives
Develop and lead program timelines, budgets, and resources to meet project achievements and deliverables
Identifies and anticipates CMC-related risks/constraints to timing and resources
Provide strategic guidance and oversight for CMC-related regulatory submissions, including IND, BLA, and other regulatory filings
Drive continuous improvement initiatives to optimize CMC processes, systems, and workflows
Lead and mentor a team of program managers 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
Foster strong relationships with external partners, vendors, and team members to support program goals and objectives
Prepare and present program updates, reports, and strategic recommendations to senior management and key team members
Stay informed of industry trends, emerging technologies, and regulatory developments in cell therapy CMC to advise program strategies and decisions
Drive continuous improvement initiatives within the CMC project management function to enhance efficiency, productivity, and quality
Advises project communications and ensures that all project customers are fully informed and knowledgeable of project activities and their status
Collaborates with functional leaders to ensure that functional area resources are sufficient to achieve project goals and objectives
Promote a culture of collaboration, cooperation, cross functional inclusion, execution excellence, effective communication and cross-functional problem-solving to become a successful team
Provides leadership to the team and functional areas to anticipate and identify sophisticated project issues, which pose a challenge to achieving strategic goals. Implements plan to resolve such issues and completes corrective actions
Selects, evaluates and supports the development of direct reports
Qualification
Required
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 of leading projects/programs
Must have a relevant CMC and knowledge on developing, 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 NDA and / or MAA for an NBE
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
Company
Alexion Pharmaceuticals, Inc.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community.
1001-5000 employees
H1B Sponsorship
Alexion Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (49)
2024 (57)
2023 (51)
2022 (29)
2021 (27)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$5.8M2020-12-12Acquired
1999-02-12Post Ipo Equity· $5.8M
1996-02-29IPO
Leadership Team
Frederic Chereau
SVP, Strategy and Business Development
Imran Shakur
Director, IRT and Technology Lead
Recent News
BioWorld Financial Watch
2026-01-17
bloomberglaw.com
2025-12-20
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