Introduction to role:

AstraZeneca is seeking an initiative-taking leader for biologics process development with a focus on upstream operations. This position leads a group responsible for upstream process development to support pipeline projects from pre-clinical to commercial stage. The successful candidate will also lead technology development initiatives and define strategies to support risk-based and flexible CMC plans to support daring timelines and a growing portfolio of biologics.

About AstraZeneca in Gaithersburg, MD:

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 authorities in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.

The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria, and copy center. This is where you will find newly designed, activity-based workspaces to suit a variety of working styles while increasing collaboration between teams.

Summary of Group:

Leads a group of engineers and scientists responsible for process development activities to support early to late stage clinical and commercial manufacturing Products include mAbs, ADCs, bi- and tri-specific antibodies, fusion proteins, vaccines, and other novel biologic modalities. Process development responsibilities include development, optimization and characterization of robust cell culture processes used in fed-batch and continuous manufacturing operations to produce clinical and commercial biologics.

• Drives strategy and provides leadership in the development of innovative technologies (including PAT), digitalization, and automation of upstream processes for traditional and emerging biologic modalities
• Drives development and implementation of agile and risk-based approaches to define CMC strategies for process development and characterization to support efficient and accelerated project delivery
• Provides technical leadership and mentorship on strategies and approaches for late-stage process development, process validation, and commercial registration.
• Authors, reviews, and approves technical reports, upstream development sections of regulatory submissions (INDs/BLAs), and responses to questions from health authorities
• Builds positive relationships and partners with other leaders across Biopharmaceutical Development, AZ Bio-Operations, Quality, Regulatory, and external CMOs to ensure that AZ Biologics Portfolio is progressed with a sense of urgency
• Supports the professional development of the members in the CCFS department
• This position requires supervision of 4-6 employees
• Position may require occasional weekend and/or late-night work (campaign support) and potential travel to manufacturing sites (domestic and international)

Education/Experience:

• Advanced education (Ph.D or equivalent) in biology, chemical engineering, biochemical engineering, or related scientific field. Must have industrially relevant experience, 10+ years of experience in bioprocess development.

Required Skills:

• Consistent track record of success in developing, optimizing, and transferring cell culture processes to manufacturing
• Fundamental understanding of upstream unit operations and scale-up/scale-down principles for biopharmaceuticals
• In depth knowledge of CMC aspects of biopharmaceutical development processes.
• Demonstrated ability to lead technical line functions and matrix teams to deliver projects and implement new technologies
• Knowledge of GMP manufacturing principles and documentation
• Excellent teamwork and communication skills, including authoring/reviewing regulatory submissions
• Strong people skills and demonstrated ability to effectively work across a large organization

Desirable Skills/Experience:

• Experience with biopharmaceutical modalities in addition to recombinant proteins and/or monoclonal antibodies such as antibody-drug conjugates, viral products, nucleic acids and/or cell therapies
• Extensive knowledge of commercialization activities (process characterization, validation, BLA preparation and inspection support) for biopharmaceutical products

When we put unexpected teams in the same room, we fuel bold thinking with the power to encourage life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That is why we work, on average, a minimum of three days per week from the office. But that does not mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and daring world.

Why AstraZeneca?

At AstraZeneca, we are not just about treating diseases - we're about reimagining medicine. We are a diverse and open-minded team harnessing our different skills and experiences. Our differences enable us to explore new ideas and ways of doing things. It keeps us on our toes and excited for what is next. We are part of the solution, involved in key discussions, in our role we function as both a drug developer and Regulator. We think broadly about patients and what it takes to prevent and treat diseases to develop progressive solutions.

So, what’s next!

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

Where can I find out more?

Check out our landing page for more information on our BPD group https://careers.astrazeneca.com/bpd

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Date Posted

05-Mar-2024

Closing Date

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.