Director, CMC Program Management

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 most complex 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 Technical Operations CMC Project Management Director is responsible for leading cross-functional teams within Technical Operations on multiple projects from inception through completion, coordinating activities to develop the physical product, manufacturing process, supply chain and regulatory files. This position is based in Santa Monica, CA and reports to the Head of Technical Operations 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 complies with established practices, policies, and processes. Project issues and risks must be identified and tracked and plans to resolve these issues must be developed and solutions executed. 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 manage program timelines, budgets, and resources to meet project milestones 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 high performance, collaboration, and professional development.

Consistently maintains a positive & professional approach in communication, e.g. maintaining composure under pressure and managing up. Foster strong relationships with external partners, vendors, and stakeholders to support program goals and objectives. Prepare and present program updates, reports, and strategic recommendations to senior management and key stakeholders.

Stay informed of industry trends, emerging technologies, and regulatory developments in cell therapy CMC to inform program strategies and decisions. Drive continuous improvement initiatives within the CMC project management function to enhance efficiency, productivity, and quality. Directs 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 high-performing team. Supervisory Responsibilities Provides leadership to the team and functional areas to anticipate and identify complex project issues, which pose a challenge to achieving strategic goals.

Implements plan to resolve such issues and executes corrective actions. Selects, evaluates and supports the development of direct reports. Education and Experience 12 years with BS/BA degree in a technical, engineering or life sciences discipline; 10 years with MS/MA or MBA 8 years of leading experience Must have a relevant CMC and knowledge on developing, and manufacturing along with a thorough working knowledge 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 in Biotech or Cell Therapy process development and/or product launch preferred.

The annual base salary for this position ranges from $170,000 to $201,000 . However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and 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. Benefits Short-term incentive bonus opportunity Equity-based long-term incentive program 401(k) plan Paid vacation and holidays; paid leaves Health benefits including medical, prescription drug, dental, and vision coverage.

DE&I Statement AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be.

We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.