Associate Director, CMC Program Management at AstraZeneca in Santa Monica, California

Job Description:

Position Summary:



The CMC Program Lead is responsible for leading cross-functional teams within Cell Therapy Development and Operations (CTDO) on multiple programs from inception through completion, coordinating activities to develop the physical product, manufacturing process, supply chain and regulatory files. You will be specifically responsible for leading CMC of one or more clinical programs. This position is based in Santa Monica, CA and reports to the Head of Process Sciences, Analytics and Technology, CTDO.



Responsibilities:

• Build and mature the CMC function within CTDO.
  
  

• Work with technology, process development, analytical development, manufacturing and partner 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.
  
  

• Project issues must be identified and tracked and plans to resolve these issues must be developed and solutions implemented.
  
  

• Lead the strategic planning CMC programs for cell therapy products from early development through commercialization.
  
  

• Collaborate with R&D, Manufacturing, Quality, Regulatory Affairs, and other departments to guide program success and agreement on our goals.
  
  

• Be a CTDO representative on the Global Project Team
  
  

• Manage program timelines, budgets, and resources to meet project milestones.
  
  

• Identify and anticipate CMC-related risks/constraints to timing and resources.
  
  

• Provide strategic guidance for CMC-related regulatory submissions, including IND, BLA, and other regulatory filings.
  
  

• Improve programs to improve CMC processes, and workflows.
  
  

• Lead a team of program managers and specialists to ensure collaboration, and professional development.
  
  

• Foster relationships with external partners, vendors, and partners to support program goals.
  
  

• Present program updates, reports, and recommendations to senior management and important partners.
  
  

• Stay informed of industry trends, latest technologies, and regulatory developments in cell therapy CMC to inform program strategies and decisions.
  
  

• Improve plans within the CMC project management function to enhance efficiency, productivity, and quality.
  
  

• Direct project communications and ensure that all project customers are informed and knowledgeable of project activities and their status.
  
  

• Collaborate with functional leaders to ensure that functional area resources are to achieve project goals.
  
  

Supervisory Responsibilities

• Provide leadership to collaborate with GPT the team and departments to identify complex project issues, which pose a challenge to achieving strategic goals. Implement plan to resolve such issues and executes corrective actions.
  
  

Required Abilities

• Must have a relevant CMC and knowledge on developing, and manufacturing along with working knowledge of the Biotech or Cell Therapy industry, relevant regulations.
  
  

• Have experience leading matrix teams in a regulated environment.
  
  

• Have authored CMC sections of NDA and MAA for an NBE
  
  

• Must have a deep understanding of the drug development process.
  
  

• Experience in Biotech or Cell Therapy process development and product launch preferred.
  
  

Education and Experience

• BA or BS degree in a technical, engineering or life sciences discipline; an advanced degree in business or in a scientific field is desirable.
  
  

• Experience (10+ years) in pharmaceutical or biotechnology industry with a focus on CMC project management, drug development, manufacturing, or related areas.
  
  

The annual base salary for this position ranges from $135,714 to $203,571. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).



Our Benefits:



Benefits offered include:

• A qualified retirement program [401(k) plan]
  
  


• Paid vacation, holidays, and paid leaves
  
  


• Health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.
  
  

#celltherapy #LI-Onsite


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. Apply Now