Senior Director, Manufacturing Technology and Development, Manufacturing Sciences

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.

Introduction to role:

Are you ready to lead the charge in redefining drug development strategies into reality As the Senior Director of Manufacturing Technology and Development within Manufacturing Sciences youll 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 youll 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.

Accountabilities:

What youll do:

• Provide senior-level technical leadership throughout all phases of the sites life cycleincluding 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.

Essential Skills/Experience:

• Advanced degree (Ph.D. Pharm.D. or Masters 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.

Desirable Skills/Experience:

• 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.

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base pay for this position ranges from $182142 to $273214.. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and 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). Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and 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. If hired employee will be in an at-will position and the Company reserves the right to modify base pay (as well as 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.

At AstraZeneca innovation is at our heart. We are committed to turning life-changing science into medicines that make a difference for patients worldwide. Our diverse team thrives on curiosity and collaboration pushing boundaries to deliver rapid approvals that bring new treatments to those who need them most. With opportunities to work on projects at all stages of development youll be part of a dynamic environment where your contributions are valued. We support your professional growth through our Regulatory academy and development path initiatives.

Ready to make an impact Apply now to join our team!

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