Senior Director, CMC, Analytical Stewardship, and Stats Excellence
- Location
- Gaithersburg, MD
- Listed
- Today
Job Summary
As Senior Director, Complex CMC Program Leadership, AI/Digital Transformation & Statistical Excellence, you will lead complex global CMC programs from late-stage development through commercialization and lifecycle management.
You will integrate technical strategy, regulatory readiness, analytical excellence and digital innovation across Global Technical Operations (GTO) and partner functions.
What You'll Do
Complex CMC Program Leadership | 60%
- Lead global CMC teams for sophisticated biologics programs, including monoclonal antibodies, antibody-drug conjugates, recombinant proteins and emerging modalities.
- Develop CMC strategies across late-stage development, validation, PPQ, regulatory filing, commercialization, launch, technology transfer and ongoing product management.
- Align cross-functional teams and external partners on technical priorities, resources, risks and key decisions to support effective program execution.
- Provide strategic direction for product quality, supply, post-approval changes, manufacturing network changes, complex investigations and inspection readiness.
- Lead CMC content and technical responses for global regulatory submissions and health authority interactions.
AI, Digital & Automation | 20%
- Develop a GTO digital roadmap supporting CMC delivery, analytical stewardship, knowledge transition, and ongoing lifecycle coordination.
- Advance responsible use of generative AI and analytics for technical authoring, information synthesis, risk identification and decision support.
- Identify automation and data opportunities that simplify workflows, improve traceability and support predictive monitoring.
- Establish governance and adoption plans for AI and digital solutions, including data quality, validation, compliance, human oversight and value measurement.
Analytical Stewardship & Statistical Excellence | 20%
- Provide strategic oversight of analytical method lifecycle management, validation, verification, transfer, comparability and method replacement.
- Guide analytical methods to commercial readiness and prepare the network to support diverse products and analytical technologies.
- Apply numerical and analytical expertise to build study design, sampling, comparability, method transfer, acceptance criteria, uncertainty assessment, multivariate analysis and product quality monitoring.
- Advance statistical analysis, predictive analytics and process monitoring to support control strategies and lifecycle decisions.
Leadership
- Build and lead an inclusive global organization with strong CMC, analytical, statistical and digital capabilities.
- Coach leaders and experts while supporting capability development, succession and knowledge continuity.
- Develop collaboration and accountability while aligning resources and priorities with business needs.
Essential Qualifications
- Advanced degree (PhD, MS) in Statistics, Biostatistics, Biochemistry, Analytical Chemistry, Biotechnology, Chemical Engineering, Pharmaceutical Sciences, Data Science or a related field.
- 15+ years of experience in biologics CMC development, commercialization, technical operations, MSAT, analytical sciences, technology transfer or product stewardship.
- Experience leading intricate global CMC initiatives through pivotal development, validation, filing, launch and lifecycle changes.
- Strong knowledge of global regulatory expectations and ICH mentorship for biologics CMC, analytical methods, validation, product handover, and ongoing management throughout the product life.
- Expertise applying statistical and quantitative methods to pharmaceutical development, manufacturing or analytical data.
- Strong critical thinking, communication and executive influence skills.
Preferred Qualifications
- Experience applying AI, digital technologies, automation, advanced analytics or data products in a regulated pharmaceutical environment.
Why Astrazeneca?
At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and spark your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.
The annual base pay for this position ranges from $ 216,996.00-$325,494.00 Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
- #LI-Hybrid
- Date Posted
- 13-Nov-2026
- Closing Date
- 26-Nov-2026
Equal opportunity and legal notices
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.
From Astrazeneca's careers page, first listed on Rolev.ai on November 14, 2026. Rolev.ai is not the employer.
How Rolev.ai helps with this application
Rolev.ai is a job search and application tool for US job seekers. For this Senior Director, CMC, Analytical Stewardship, and Stats Excellence role at Astrazeneca, it shows how your resume fits, tailors your resume to the posting, and prepares the application for you to review.
See how you fit
Openings from employer career sites are ranked against your whole resume—and searchable inside Claude, ChatGPT, and Cursor via Rolev.ai MCP.
Tailor without inventing
Every change to your resume is checked against your original. New experience goes in only with your yes—zero fabricated claims.
Draft the full kit
Tailored and Full Match resumes, role-specific cover letters, and answers to employer screening questions are prepared in seconds.
1-Click Extension Autofill
The Chrome extension fills the employer's Greenhouse, Workday, Lever, or Ashby form in 1 click. You review it and press Submit.
Similar roles
- Senior Director, Program ManagementInsmed Incorporated · Research Development Lab - San Diego
- Senior Director, Home Services Business DevelopmentTricon American Homes · Tustin, CA
- Senior Director, Fulfillment OperationsSaddle Creek Logistics Services · Litchfield Park, AZ
- Senior Director of Human ResourcesTorch Technologies, Inc. · Huntsville, AL
- Senior Director, Head of Enterprise ArchitectureFlywire · Chicago, IL
- Senior Director, Research TechnologyProfessional Case Management · Remote (US)
More at Astrazeneca
All AstraZeneca jobsCommon questions
Where is the Senior Director, CMC, Analytical Stewardship, and Stats Excellence job at Astrazeneca located?
This Senior Director, CMC, Analytical Stewardship, and Stats Excellence position at Astrazeneca is located in Gaithersburg, MD. Always check Astrazeneca's application page for specific state eligibility or relocation policies.
How do I apply for the Senior Director, CMC, Analytical Stewardship, and Stats Excellence position at Astrazeneca?
This listing links directly to Astrazeneca's Workday application page. You can apply directly on Astrazeneca's site, or use Rolev.ai to check your resume fit, generate a zero-hallucination tailored resume and cover letter for this posting, and autofill the Workday application form in 1 click with the Rolev.ai Chrome extension. You always review the form and press Submit yourself.