Associate Director CMC – Esobiotec - AstraZeneca group

Job Description

Do you thrive in innovative environments and are committed to advancing transformative therapies ?

As a proud new member of the AstraZeneca family, Esobiotec continues to set new standards in pioneering biotechnological research. With a shared vision to transform the future of medicine, our partnership leverages AstraZeneca’s global reach and rich heritage in scientific innovation, amplifying Esobiotec’s unique culture of creativity and breakthrough advances in cell-based therapies and immunology. At Esobiotec, now backed by the resources and expertise of one of the world’s leading biopharmaceutical companies, you’ll find a dynamic, collaborative environment where scientific passion drives real-world impact. Be part of a team where your work will contribute to shaping the next generation of life-changing treatments and help us push the boundaries of science to improve patients’ lives worldwide.

We are looking for an inspiring CMC leader to drive innovation in the manufacturing and development of our pioneering lentiviral therapies. Join our mission-driven team and help shape the future of cell and gene therapy with your expertise in process development, analytics, and regulatory strategy. We value diverse perspectives and a collaborative, growth-minded approach.

What You’ll Do

• Lead and coordinate a talented CMC team responsible for multiple manufacturing campaigns supporting Investigator Initiated Trials (IIT), IND-enabling studies, and clinical programs for EsoBiotec’s lentiviral products.
• Design, optimize, and scale up upstream and downstream manufacturing processes, guiding products from research through GMP-readiness.
• Champion the development of robust analytical methods and ensure excellence in process control and product characterization.
• Serve as a strategic partner to Regulatory Affairs, helping to shape CMC strategies and prepare high-quality regulatory submissions.
• Oversee pre-GMP and GMP vector manufacturing and testing at external CDMOs, ensuring quality, timelines, and cost-effectiveness.
• Review and approve manufacturing and analytical plans and reports, both internally and from partner organizations, maintaining program timelines and budgets.
• Recruit, mentor, and develop a high-performing, diverse team, fostering scientific rigor and a culture of continuous improvement.
• Direct technical transfer activities to CDMOs, ensuring seamless communication and execution at every step.

What You’ll Bring

• Advanced scientific qualifications, such as an MSc or PhD, in Virology, Biochemistry, Cell Biology, Molecular Biology, Biomedical Engineering, or a closely related field.
• At least 10 years of postgraduate industrial experience in manufacturing and analytical development, including hands-on expertise in GMP environments.
• Demonstrated excellence in managing CMC teams and leading successful IND-enabling programs for biopharmaceutical products.
• In-depth understanding of regulatory guidelines and requirements essential for CMC program development.
• Superior scientific and technical writing in English, as well as outstanding verbal communication skills, ensuring clarity in both internal and external collaborations.
• A meticulous, detail-oriented approach to problem-solving, with a drive for scientific rigor and quality at every stage.
• Deep passion and expertise in gene therapy, coupled with strong analytical thinking and innovation.
• Proven ability to build effective relationships, collaborate across teams, and foster a supportive and diverse work environment.

Desirable skills:

• Gene or cell therapy products experience
• Previous vector manufacturing with external partners CMDOs

At AstraZeneca Group, we are committed to pushing the boundaries of science to transform the lives of patients living with cancer. Our diverse team collaborates seamlessly, drawing on collective wisdom from across the globe to tackle the toughest medical challenges. With one of the broadest Oncology pipelines in the industry, we offer unparalleled opportunities to work with novel drugs and innovative approaches. Empowered by courage and curiosity, we take smart risks and challenge norms to make a meaningful difference in patient outcomes.

So, what is next:

If you're ready to shape the future of gene therapy and lead high-impact teams in a vibrant, mission-driven company, we would love to hear from you!

Welcome with your application, in English, latest by the 15/07/2025

To find out more:

Company site: https://www.esobiotec.com/

Group site: https://www.astrazeneca.com/

Our social media, Follow us on LinkedIn: Esobiotec and AstraZeneca

Inclusion & Diversity: https://careers.astrazeneca.com/inclusion-diversity

Career site: https://careers.astrazeneca.com/

Date Posted

Closing Date

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.