Senior Scientist/Engineer, Process Engineer for Drug/Combo Products
AstraZeneca

Gaithersburg, Maryland

Posted in Pharmaceuticals


This job has expired.

Job Info


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.

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.

Main Duties & Responsibilities:

The candidate will have responsibility for developing processes for formulation, filling, and device assembly for biotech drug and combination products, which may include vials, prefilled syringes, cartridges, as well as auto-injectors, and/or other drug delivery devices.

Primary responsibilities will include:

1) Process Design and Development: Develop manufacturing processes, specify requirements of manufacturing equipment and support equipment design and build, perform process risk assessments such as FMEA, design characterization and engineering studies, develop control strategies, author protocols, technical reports and regulatory filing sections. Provide technical rigor in design for manufacturing, experimental design, data analysis, and technical writing. Develop pilot laboratory fill and assembly process capabilities.

2) Leadership: Contribute strategic thinking to drug and combination product development teams by providing knowledgeable advice on design for manufacturing, equipment vendor selection, manufacturing site selection / alternatives, project lead time and budget estimates. Advise functions and teams on new manufacturing technology selection and development. Develop risk-based characterization and validation strategies for manufacturing processes. Propose general working strategies and risk-based project strategies that meet requirements of design control, product quality, cGMP, as well as timeline and budget constraints. Research and design small scale comparability studies and template technology transfer processes.

3) Tech Transfer and Validation: Lead late-stage and commercial technical transfers to CMOs and internal facilities. Organize an internal sending unit team including development functions (device, analytical, packaging, formulation, fill and assembly process SMEs), supply chain, project management and QA. Ensure correct implementation of control strategies for the drug product and device into manufacturing records. Design and oversee validation activities for equipment, manufacturing processes, and shipping. Manage timelines and activities internally, communicate goals and oversee successful delivery at the receiving site. Some travel (5-15 trips per year) in the US and abroad is required.

Educational requirements include a degree in mechanical, chemical, or pharmaceutical engineering, chemistry, materials science, or a related engineering or pharmaceutical science field. Typical candidates will have a BS plus 10 or MS with at least 8years of experience, or a PhD.

Capability, skill and/or knowledge in the following areas is desirable:

  • Biopharmaceutical / combination drug product development
  • Combination product and cGMP regulations
  • Knowledge of formulation and fill-finish unit operations such as freeze-thaw, formulation, filtration, mixing, and aseptic filling.
  • Knowledge of assembly, label and packaging processes and equipment
  • Equipment, Process and Shipping Validation
  • QbD, experimental design, statistics, data analysis
  • Leadership and interpersonal communication
  • Technical writing and documentation

Experience: Suitable experience may include development of combination products and/or associated manufacturing processes, Quality oversight or validation of fill-finish and/or device assembly processes. Tech transfer experience or experience organizing and leading cross-functional teams is valuable. A high degree of self-motivation, mechanical skill and technical rigor is required.

Why AstraZeneca?

We are proud to work for AstraZeneca for many reasons. Most recently, we are proud of our development of a vaccine and antibodies to treat or prevent COVID19. During the pandemic, we have pledged to forgo any profit from these products! And we are making these products available globally! We are working incredibly hard on these and other projects, and need you to join us so we can be successful.

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 https://careers.astrazeneca.com/bpd

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en


This job has expired.

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