Senior Director, Manufacturing Technology and Development, Manufacturing Sciences

AstraZeneca • Gaithersburg, MD

82d • $182,142 - $273,214

About The Position

At AstraZeneca, we win through the science, it is at the heart of our every success. Every decision is rooted in the limitless possibilities of what science can do. We push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do. It gives us a reason to come to work every day. It reminds us why we exist as a company. It helps us deliver benefits to patients and build new value for shareholders. It also sets the context for our employees’ activities and the roles of our teams, partners, and other collaborators. AstraZeneca has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent. As the Senior Director of Manufacturing Technology and Development within Manufacturing Sciences, you'll provide visionary technical leadership to design, build, and start-up innovative clinical manufacturing sites dedicated to biologics drug substance. These innovative facilities will focus on monoclonal antibodies and other large molecule modalities, incorporating sophisticated manufacturing capabilities such as fed-batch, intensified batch, and integrated continuous bioprocessing. With high-containment antibody-drug conjugate capability and flexible manufacturing suites, you'll have the opportunity to design capabilities to support technologies such as fermentation, plasmid DNA, messenger RNA, and viral vector production. Drive the technical strategy from conceptual design through validation, ensuring compliance with cGMP standards in a fast-paced, innovation-driven environment.

Requirements

• Advanced degree (Ph.D., Pharm.D., or Master’s degree) or Bachelors with equivalent experience in Biochemical Engineering, Chemical Engineering, Biotechnology, or related scientific field.
• Deep technical expertise (typically 10-15 years) in biologics drug substance manufacturing technology including process scale-up and cGMP clinical and/or commercial manufacturing.
• Track record of successful technical leadership and delivery in large capital projects (>$100M+), preferably in greenfield or brownfield facility builds.
• Significant experience with high-containment manufacturing, ADC conjugation operations, and facility design for potent compounds is highly desirable.
• Familiarity with additional modalities such as fermentation-based processes, nucleic acid therapeutics (pDNA, mRNA), or viral vector production (AAV/lentivirus) is highly advantageous.
• Deep and current knowledge of global cGMP requirements, regulatory guidelines, and Health Authority expectations for biologics manufacturing facilities.
• Recognized as a thought leader and doer, with a reputation for operational excellence, effective risk management, and instilling a strong quality culture.

Nice To Haves

• Desired experience with traditional fed-batch, process intensification, and continuous processing approaches for biologics.
• Demonstrated excellence in multi-functional leadership, project management, and team development.
• Innovative attitude with the ability to anticipate and proactively address technical challenges.
• Exceptional communication skills capable of engaging executive leadership and external partners.
• Adept at navigating ambiguity and delivering sustainable results in fast-paced environments.
• Critical thinking with foresight to plan for future pipeline trends.
• Proficient in deploying digital solutions in manufacturing.
• Strong business sense and understanding of clinical development to commercial transition.

Responsibilities

• Provide senior-level technical leadership throughout all phases of the site’s life cycle—including conceptual and detailed design, construction, commissioning, qualification, start-up, and ongoing improvements.
• Serve as the key authority in biologics drug substance manufacturing, with deep insights into monoclonal antibody process technology.
• Be responsible for the technical build-out and operational readiness of all production lines, ensuring best-in-class containment, safety, and quality controls.
• Enable and future-proof flexible and modular manufacturing infrastructure that supports rapid technology transfer and introduction of new modalities.
• Drive the integration of digital manufacturing, sophisticated automation, data analytics, and continuous improvement tools to enhance process robustness, yield, and efficiency.
• Partner with various departments and external vendors to ensure successful and timely project execution.
• Establish and maintain thorough cGMP standards, risk management practices, and quality assurance frameworks.
• Lead, mentor, and develop a high-performing technical and implementation team to sustain a collaborative, agile, and innovation-driven culture.
• Promote a safety-first environment, championing standard methodologies in high-containment and occupational health.
• Serve as principal technical contact for inspections, regulatory interactions, and support operational/manufacturing knowledge transfer to commercial manufacturing.
• Support business strategy, capital planning, and long-term site capability development.

Benefits

• 401(k) plan
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Master's degree
• Number of Employees: 5,001-10,000 employees