CMC Project Leader, Vaccines and Immune Therapies (V&I), BioPharmaceutical Development

Do you have a passion forscience Would you like to apply yourexpertisetoimpacta company that followsthe scienceand turns ideas into life changing medicines Then AstraZeneca might be the one for you!

At AstraZeneca we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial thinkingbigand working together to make the impossible a reality. If you are swift to action confident to lead willing to collaborate and curious about what science can do thenyoureour kind of person.

Summary of the group

TheBiologics CMC Project Leadership GroupdrivesAstraZeneca Biologics pipeline projects from early research to launch. Biologics CMC Project Leaders plan coordinate and deliver CMC activities in line with project requirements and company prioritization; and perform strategic planning for platform and novel processes. The group interfaces globally with research Clinical Operations Regulatory and all development functions.

The Biologics CMC Project Leader collaborates with theV&I (Vaccines and Immune Therapies)Therapeutic area (TA) in AstraZeneca theBioPharmaceuticalDevelopment (BPD) functions and leads CMC Project Teams to ensure that goals and due dates are achieved. The role provides technicalexpertiseand leadership to CMC Teams to ensure efficient planning and delivery of company strategyleveragingyour CMC Leadership experience to work with internal and external partners. The job has high complexity and the successful candidate must have a consistent record of leadership project delivery and partner management.

Main Duties & Responsibilities:

• As a Director Biologics CMC Project Leadership you will co-lead the CMC matrix teams with the CMC PM. You will be accountable for planning and delivering Vaccines and Immune Therapies CMC programs and their CMC strategies transitioned from Research through to first wave of marketing application submissions and CMC launch support ensuring project plans and development milestones are completed to meet agreed project timelines. You will also evaluate risks in real time to ensure team engagement and mitigation plans are activated as.

• Additionalresponsibilities at the Senior Directorlevelwill alsoinvolvementoring and career development of Project Leaders and CMC team members building strong trusted partnerships acrossthe V&I Therapeutic Areaand Senior Leadership Teams and influencing Senior Leaders to bridge TA and CMC requirements for portfolio projects. Align and implement BPD and Operations Global CMC program hand-offs to enable smooth transitions from development to commercial and lifecycle management activities requiring BPD support. Communicate TA strategy and prioritization to BPD partners. Lead and coordinate portfolio delivery budget and FTE needs with TA Portfolio Leads.

• Provide vaccine specificand/or infectious disease biologicsCMCexpertiseand direction to CMC Project leaders that will lead vaccineand infectious diseasebiologicsCMC programs and ensure seamless integration with early research as well as transition to commercial manufacturing.

Education & Experience Requirements Director

• Ph.D. in microbiology molecular biology biochemistrychemical engineering pharmaceuticalscienceor a related subject area with 7 years of proven experience or aMasterswith 10 years of experience or a B.S. with 13 years of experience.

• Extensive experience working inVaccinesCMC Development or equivalent (plus considerable industry experience)

• Expertiseintechnical development and project leadership of platforms like VLPs mRNA bioconjugatesmAbs and other biologic modalities.

• Experience in end-to-end CMC development ofinfectious diseasebiologicsincluding those used as prevention and treatmentworking closely with both early research as well as commercial manufacturing teams

• Demonstrated Scientific Project Leadership withanability to lead cross-functional matrix teams.

• Consistenttrack recordof CMC Biologics project delivery.

• Demonstrated ability to set and lead priorities resources performancetargetsand project initiatives in a global and regional environment.

Required Skills

• PhD

• Ability to influence strategically and persuade tactfully to obtain desired outcomes whilemaintainingeffective positive organizational relationships

• Operationalexpertisein risk management and contingency planning

• Effective problem solving and conflict resolution skills

• Ability to assess and make decisions based on scientific data

• Comfortable with ambiguity

• Excellent oral and written communication interpersonal and analytical skills

• Effective problem solving and analytical skills to tackle and manage a broad range of issues and projects and deliver innovative solutions

Why AstraZeneca

At AstraZeneca when we see an opportunity for change we seize it and make it happen because any opportunity no matter how small can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments andrecognisingtheir potential. Join us on our journey of building a new kind oforganisationto reset expectations of what a bio-pharmaceutical company can be. This meanswereopening new ways to work pioneeringcutting edgemethodsand bringing unexpected teams together.Interested Come and join our journey.

Sowhatsnext!

Are you ready to bringnew ideasand fresh thinking to the table Brilliant! We have two positions available and we hope one will be yours.

Where can I find out more

Check out our landing page for more information on our BPD group Social Media Follow AstraZeneca on LinkedIn AstraZeneca on Facebook AstraZeneca on Instagram Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.