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 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.

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.

Supervisory Responsibilities

• 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.

Education and Experience

• 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.

The annual base salary for this position ranges from $172,466.40 - $258,699.60. 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.

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and bold world.”

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.