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Director, Process Engineering & Packaging - BPD

Location Gaithersburg, Maryland, United States Job ID R-104657 Date posted 06/04/2021

Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and 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, thinking big and 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, then you’re our kind of person.

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 experts 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’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams. 

Summary of the group:

This role reports into the Process Engineering and Packaging (PEP) group for drug product process development within the Biopharmaceutical Development (BPR) function in AstraZeneca. The PEP group has accountability for drug product process development, process characterization, combination product assembly development, and packaging science and technology across a broad range of biotech product types and technologies. We support the entire portfolio from Phase 1 clinical trial materials through to marketing application and product launch.

Main Duties & Responsibilities:

The incumbent will fulfill a strategic leadership role within the Process Engineering and Packaging (PEP) organization. The PEP function develops clinical and commercial fill/finish processes, combination product assembly processes, and packaging for biopharmaceutical products in the MedImmune portfolio.  Specific accountabilities for these positions shall include: (1)  leadership of process development and packaging for clinical products; (2) development of robust drug product and device assembly processes for commercial production (in collaboration with Operations); (3) technology transfer to both internal and outsourced commercial manufacturing; (4) development and maturation of an advanced scale-down fill/finish development lab for technical support of clinical and commercial production.    The incumbent will help oversee the process development of a diverse group biopharmaceutical dosage forms, including liquid and lyophilized formulations, various primary container formats, novel drug delivery formulations (e.g. nanoparticles, high concentration formulations, etc.), drug delivery devices and packaging.  Each leader must maintain a strong technical culture and be able to establish strong working relationships at internal and external interfaces.  These positions require effective collaborative interactions with AstraZeneca leaders, particularly with the Global Biological Operations (Commercial Operations) organization and internal/external manufacturing sites within the manufacturing network.  Experience working with functions such as late stage formulation development, device development, clinical operations, supply chain, quality and regulatory are also essential. This individual must be able to effectively lead in a matrix environment and be able to influence broadly internally and externally

Specific Duties and Responsibilities include:

  • Provide technical and strategic leadership and management for the development of drug product, device assembly, and packing/labeling processes.  Scope includes accountability for design for manufacturing, development and technical support of clinical processes, clinical packaging and support of commercial packaging, technology transfer to Global Biological Operations, and ad-hoc technical support for commercial production as needed.
  • Apply scientific and engineering knowledge and tools to issues and problems arising during development and execution of processes
  • Lead and manage functional teams, including resource management, prioritization, critical assessment of technical work, support of project teams, and developing relationships with functional partners
  • Manage and mentor leaders and develop people
  • Provide leadership and create strategies to evolve the capabilities of the organization in alignment with AstraZeneca strategies, growing health authority expectations, and changing external drug product competitive landscape
  • Drive a culture of innovation and high-quality science and engineering
  • Influence regulatory strategies and provide guidance and reviews of regulatory information packages and filings/submissions
  • Challenge the status quo, yet build strong relationships with other leaders and functional partners
  • Broadly influence and educate senior leaders and the larger AstraZeneca functional areas and product teams on drug product development
  • Create solid partnerships with key interfaces and represent BPD on senior leadership teams, committees and councils
  • Ensure that AstraZeneca is a leader in the industry by being active in the external biologics manufacturing development and devices community through, for example, presenting at major conferences, participation in industry consortiums, etc.

Education & Experience Requirements:

B.S., M.S. or Ph.D. in Chemical Engineering or other relevant Engineering field, Pharmaceutical Sciences, or related field with related experience in the biopharmaceutical industry.  Strong technical and scientific skills with proven experience in development of drug product manufacturing processes and/or packaging solutions for biologics in primary containers and devices.

Bachelor's degree with 20+ years of experience OR Master's degree with 17+ years of experience OR a Ph.D. with 13+ years of experience.

Required Skills:

  • Candidate must be recognized leader in drug/combination product process or packaging development
  • Must possess in depth knowledge developing and executing strategies for drug product process development
  • Must have strong knowledge of six sigma principles and tools
  • Must have strong knowledge of QRM principles and tools
  • Experience in CMC aspects of biopharmaceutical development
  • Experience with regulatory agency interactions
  • Demonstrated ability to lead / influence cross-functionally and at a senior level within the organization, including direct experience influencing and working with senior leaders
  • Demonstrated ability to effectively lead and develop professional staff, and work in a collaborative team environment across multiple technical functions
  • Must have a strong, broad understanding of industry scientific and technical advancements in drug product manufacturing process development. Engagement within industry organization boards and task forces preferred.
  • Experience in Medical Device development
  • Must posses strong aseptic processing knowledge.  
  • Must possess strong Process validation lifecycle strategy and execution skill
  • Experience in leadership of and/or membership of enterprise level committees, initiatives or task forces

Desired Skills:

  • Strong statistical background, including SPC and DoE methodologies
  • Master Black Belt in Lean/Six Sigma
  • Vaccine development and tech transfer
  • Knowledge of assembly, label and packaging processes and equipment
  • Experience with novel and new biotech modalities (mRNA, adenovirus delivery, CAR-T therapies, ATMP,  antibody-drug conjugates, etc.)

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

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

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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.

10001124 G SCPE R&D BioPharmaceuticals

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.