Director Cell Therapy CMC Program Lead - Late Stage

AstraZeneca•Santa Monica, CA

About The Position

At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's sophisticated diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. Position Summary 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 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.

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.