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, thenyou’reour 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 strategy,leveragingyour 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 asrequired.

• 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, biochemistry,chemical 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, bioconjugates,mAbs, 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.

Education & Experience Requirements, Senior Director

• Ph.D. in microbiology, molecular biology, biochemistry,chemical engineering, pharmaceuticalscienceor a related subject area with 10 + years of experience, or aMasterswith 13+ years of experience or a B.S. with 16+ years of experience.

• Extensive experience working in Vaccines CMC Development or equivalent (plus considerable industry experience)

• Expertisein technical development and project leadership of platforms like VLPs, mRNA, bioconjugates,mAbs, and other biologic modalities. 

• Experience in end-to-end CMC development of infectious diseasebiologicsincluding those used as prevention and treatment working closely with both early research as well as commercial manufacturing teams

• Experience in end-to-end CMC development ofbiologicsworking closely with both early research as well as commercial manufacturing teams

• Extensive knowledge of the latest technical and regulatory expectationsasit relates to vaccines and infectious disease biologics.

• Experience with marketing applications, responding to questions, and pre-approvalinspectionreadiness.

Required Skills

• PhD or equivalent

• 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

The annual base pay for this position ranges from $206,993.60 - $310,490.40 USD USD. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

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 meanswe’reopening new ways to work, pioneeringcutting edgemethodsand bringing unexpected teams together.Interested? Come and join our journey.

So,what’snext! 

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 https://careers.astrazeneca.com/bpd

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