Senior Engineer - Biologic & Novel Therapeutic Drug Product Process Development

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 crafting 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 balanced. 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

The position sits within the Process Engineering and Packaging (PEP) department within the Biologic Drug & Combination Product development parent organization (Dosage Form Design and Development, DFDD).  The PEP group is staffed with engineers and scientists who develop manufacturing processes such as compounding, aseptic filling, device assembly, and packaging.  PEP designs these processes and tech transfers them to manufacturing sites for clinical products up through licensure.  Process development, characterization and validation are core responsibilities of the department.

Main Duties & Responsibilities

Primary responsibilities will include:

1) Process Design and Development: Design manufacturing processes suitable for clinical or commercial-scale production for biologic and novel therapeutic products.  Evaluate current and new manufacturing technology to drive better quality and operational advantages.  Develop pilot laboratory capabilities required for biologic and novel therapies.  Characterize processes to establish acceptable processing conditions. 

2) Tech Transfer and Validation: Support clinical-stage and commercial technical transfers to internal facilities and contract manufacturers.  Work within an internal sending unit team including development functions (device, analytical, packaging, formulation, fill and assembly process SMEs), supply chain, project management and QA. 

Education & Experience Requirements:

Educational requirements - a degree in mechanical, chemical, or pharmaceutical engineering, chemistry, materials science, or a related engineering or pharmaceutical science field. 

BS or MS with at least 8 years of experience, or a PhD and 0 yrs. experience

Required Skills

The candidate should have at lease introductory-level knowledge in several of the following areas:

• Biopharmaceutical / combination drug product development
• Cell and gene therapy
• Fill-finish unit operations such as filtration, mixing, and aseptic filling.
• Experimental design, wet-laboratory work, and data analysis
• Leadership, communication, technical writing

Desired Skills

• It is advantageous if the candidate has prior experience in biologic drug development or manufacturing. 
• It is also advantageous if the candidate has cursory knowledge of regulatory guidance such as for biologics, cell and gene therapy, aseptic processing, validation, cGMP, and combination products.

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?

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

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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 authorization and employment eligibility verification requirements.