05 Jan, 2022

Principal Scientist/Director

  • AstraZeneca
  • Gaithersburg, MD, USA
Process Engineer Biochemicals / Pharmaceuticals

Job Description

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:
Cell Culture Fermentation Sciences (CCFS) designs, develops, optimizes and validates cell culture and fermentation processes for a wide range of biological products. The team generates optimal cell lines and is also responsible for technology transfers into manufacturing. High throughput scale-down models are employed to develop media and processes to support production. The team has occupied a leadership position in industry in terms of antibody productivity and incorporates the latest developments in automation and analytics into its work.

Main Duties & Responsibilities:
• Lead one or more teams of scientists who support process, analytical and delivery for the manufacture of therapeutic proteins, leveraging intensified and/or perfusion processes, from clinical development through commercial launch in accordance with appropriate Safety, Health & Environment (SHE), quality and compliance standards, e.g. Good Laboratory Practice (GLP)
• Oversee and guide design, execution, and interpretation of experimental results to make strategic recommendations to larger AZ organization by collaborating with others, including senior management and cross-functional specialists, on project related issues such as design, progress, priorities and resourcing as well as on future strategies
• Lead projects within and outside of function, as well as across regions, possibly spanning multiple functions including presentation of scientific and technological developments internally and externally
• Provide input and leadership on technology/opportunity evaluation, process development and manufacturing strategies through up-to-date knowledge of technical advances of potential benefit to the business, in broad area of expertise
• Performance manage a team of scientists, setting goals and objectives and leading all aspects of their professional development
• Author/review IND/BLA sections and responses to questions to support regulatory filings as well as author/review technical reports and contribute to AZ scientific profile in the form of presentations, publications, patents and leadership in external science initiatives deliver presentations utilizing sound scientific reasoning and interpretation of the available data

Education & Experience Requirements:
Bachelor's Degree in chemical engineering, biotechnology, biology or related scientific field with 12 years of relevant experience; OR Master's Degree with 10 years of relevant experience; OR PhD and 6 years of relevant experience in the biotech or biopharmaceutical industry with at least 3 years of leadership experience in developing viral manufacturing processes for clinic

Required Skills:
• Industrial experience in developing and optimizing unit operations for recombinant therapeutic proteins using intensified/perfusion processes, medium development, and scale-up and manufacturing for clinic
• Expertise in unit operations involved in recombinant therapeutic protein development
• Ability to advise and lead projects and teams
• Knowledge of relevant legislation, GMP, regulations, and developments in area of recombinant therapeutic proteins and perfusion, intensified, or continuous manufacturing processes
• Understanding of patent and IP strategies

Desired Skills
• Process characterization, knowledge of Designs of Experiments, statistical analysis, and process engineering skills
• Prior success with process development and technology transfer to manufacturing for an intensified, perfusion, and/or continuous manufacturing process leading to regulatory IND or CTA filings and providing drug product supply for early to mid-stage clinical trials
• Proven ability to lead a team
• Experience in the development and/or manufacture of advanced therapeutic manufacturing products (such as mRNA and viral vectors)

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.

Apply Now