• Job Description

  Req#: R-199330

  G lobal Tech Ops, New Modalities – Director/Senior Director , Biologics Platform Technology

  Career Level Key Responsibilities:

  The Global Technical Operations Director/Senior Director , Platform Technology is a cross-functional leadership position representing Biologics Operations on key early leadership teams with the primary responsibility for strategic planning and coordination of technical leadership and support from the Operations global technical network t o key customers across the enterprise . This person will work closely with Global Supply, Quality and t he Biologics Research and Development teams to tackle new, unique and different biologic medicines including: Continuous and intensified manfuacturing , V iral Therapies (Gene therapy and oncolytic), Nucleic Acid therapies ( e.g. mRNA, saRNA ), Antibody Conjugates (ADCs, Radio Conjugates), in addition to other pipeline , traditional mammalian or fermentation produced biologics.

  Essential Job Functions:

  • Lead large cross-functional /matrix teams, formed across multiple SET areas , to be a change champion for new manufacturing technologies and new modalities enabling processes

  • Using a deep technical understanding, codevelop continuous and intensified manufactured platforms for use in worldwide network of manufacturing plants

  • Acting as platform and early technical leads for n ew and existing Modalities, lead Operations engagement with development technical and leadership teams, including, but not limited to:

  • CMC and clinical strategy teams

  • Manufacturing and Supply p latform teams

  • Pharmaceutical Development leadership teams

  • Operations leadership, including External Sourcing, Global Supply and Strategy, and Biologics Leadership

  • Working and leading collaboratively in a Matrix Environment, e stablish Operations standard work for new and existing modalities , collaborating closely with development partners to maintain including:

  • New Manufacturing Technology introduction process for New Modalities

  • Own the Biologics Operations New Technology roadmap

  • Lead or co-lead evaluation of adaptations that can be made to our internal sites for new modalities

  • Establish and lead a technical network of key influencers and decision-makers to evaluate and propose new technologies and processes to prepare Operations for New M odalities and improve existing platforms

  • As new network sites are established , working with the site, establish tech transfer and site technical business processes, in addition to a talent pipeline

  • Co-ordinate partnership of GTO team with Regulatory, Quality Assurance, and CMC teams to support writing the technical content of regulatory filings and ensure flexibilities are built in to minimize impact of future changes

  • For virtual sites in network, e nsure that full scope of MS&T support is provided to Virtual site for tech transfer and commercial manufacturing for all products and sites ( CMOs and OTLs) , working with the existing GTO teams. These responsibilities include :

  • Ensure timely and efficient communication between GTO technical team internally and externally with CMOs

  • Oversee the technical accountability and responsibilities for virtual site are met by leveraging the GTO matrix organization . Communicate/escalate technical concerns/risks/issues to the GTO and Biologics leadership team, as appropriate

  • Escalation of technical risks/issues and resource needs

  • Alignment of bio-operations technical strategies , Score-card updates, business planning and financial updates

  • Ensure technical capability builds can support product portfolio and bio enterprise strategy align priorities of CMC technical teams and Biologics Operations

  • Provide input and leadership on alignment of business processes and ways of working .

  Requirements:

  • Acknowledged e xperience and network in a Commercial/ late-stage manufacturing setting

  • Deep understanding of traditional and emergin g biologics processes, particularly continuous or intensified processing

  • Proficiency in change leadership and the ability to lead teams and navigate in complex environments

  • Proven history of regulatory document authoring or regulatory technical strategy development

  • Bachelor of Science with 1 5 + Years of experience in biologics manufacturing; 1 2 + years with advanced degree

  • The ability to co-create and collaborate in complex and agile environments

  Additional skills desired :

  • Ability to manage people, both directly and in matrix environment

  • Late phase e xperience in nucleic acid manufacturing, formulation, and/or formulation analytics

  • Proficiency with PowerBI , PowerAutomate and Microsoft Office suite of visualization tools

  • Understanding and competency in DoE study design

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

  Why AstraZeneca?

  In Quality at AstraZeneca, our work is important and valued. We have an unrivalled forward-looking mindset, making it an ideal place to work at the forefront and learn how to add real value to a business throughout the lifecycle of our products. We are always innovating, trialing the latest models and technologies to improve reliability and excellence in our processes. We are a team of ambitious people, who want to go far and we're all here to achieve. We take Quality seriously and have a clear ambition to shift the mindset around Quality. It's more than just following procedures and regulations; it's about adding value for our patients, which ultimately benefits the business.

  Date Posted

  18-Jul-2024

  Closing Date

  31-Jul-2024Our 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.

• About the company

  AstraZeneca PLC is a British-Swedish multinational pharmaceutical and biopharmaceutical company with its global headquarters in Cambridge, England.

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