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Director, External Drug Substance Manufacturing- Gaithersburg, MD

Lieu Gaithersburg, Maryland, États-Unis Job ID R-119456 Date de publication 09/16/2021

Director, External Drug Substance Manufacturing- Gaithersburg, MD

At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life.

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world.  This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. 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’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams.  Come and thrive in our vibrant, energizing, connected and encouraging culture and make a difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work.

In Biologics Global Technical Operations (GTO), we work closely with AstraZeneca’s manufacturing network of internal sites and external manufacturing partners (CMOs), our colleagues in R&D, Quality, Regulatory, Supply Chain, and Commercial to provide technical leadership to ensure delivery of quality products to our patients and support our product pipeline. This role will report directly to the Director GTO Lead for Biologics External Supply and will be based in the United States to cover multiple territories.

As the Director, you will be assigned a global portfolio of late-stage or commercial products, with overall responsibility of providing hands-on technical leadership for ongoing commercial manufacturing and managing post-approval changes.  You will be the key point of contact with assigned CMO partners and work with CMO subject matter experts in manufacturing, technical and quality teams supporting AZ products.   In this capacity, you will work closely with manufacturing sites (internal or external), other GTO functions, R&D, Quality, Regulatory, and Supply Chain organizations.  You will also serve as the GTO BES (Biologics External Supply) representative on the Product Commercial Manufacturing Team as applicable. 

What you’ll do:

  • Serve as the technical single point of contact between CMOs, Manufacturing Sciences & Technology, and Manufacturing into AZ Global Tech Ops teams to resolve production issues, deviations and negative trends by interfacing with relevant manufacturing site(s), Quality/Regulatory, Engineering, Validation, and Development to implement solutions.
  • Deliver indirect scientific or technical mentorship and leadership to Engineers, Scientists and Technicians to enable them to optimally meet their project objectives.
  • Manage continuous improvement projects and lifecycle of commercial products in working with other relevant Global Tech Ops teams.
  • Partner with team members from GTO, BES, and Global Supplier Quality to drive right first time technology transfers.
  • Support preparation of regulatory submissions, oversight during inspections and audits, and respond to questions from regulatory bodies.
  • Ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. QSR/ISO/MDD/GMP/GLP and SHE requirements.
  • Maintain an awareness of the status of core technical challenges and opportunities in area of expertise.
  • Create and maintain control strategies, design and risk management documentation
  • Work collaboratively to build technical communities.
  • To succeed in this role, you will need to be self-motivated, innovative, have strong technical and communication skills, and a deep understanding of biologics manufacturing, quality, and process development. 

Essential for the role:

  • Degree in an engineering or scientific discipline with experience in biopharmaceutical manufacturing/development/process engineering:
    • B.S with 14+ years of experience
    • M.S. with 12+ years of experience
    • PhD with 10+ years of experience

  • Extensive technical knowledge of commercial biologics manufacturing with strong focus on mammalian cell culture and purification processes.  Prior experience with late phase Drug Substance, Vaccine Manufacturing, and regulatory authority submissions/ global technology transfers/commercial Manufacturing Science and Technology required.
  • Strong knowledge of regulatory authority expectations and Quality compliance.
  • Ability to successfully influence across levels, across functions, with senior leaders and technical leaders both at AZ and SBL.  Strong communication skills.
  • Ability to work in a complex, dynamic, global environment; thinking strategically and balancing both long and short-term priorities
  • Ability to work on multiple projects and meet deadlines as needed; Emphasis on results-oriented, strong planning and execution skills
  • Ability and willingness to travel ~10% to AstraZeneca sites in the US/ EU.

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 and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

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About Operations

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 authorisation and employment eligibility verification requirements.

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