Senior Scientist / Principal Scientist, Fill-Finish Process Engineer for Biologics Drug Products - BPD
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:
We are seeking a Senior or Principal Scientist/Engineer to join the Process Engineering and Packaging team (PEP). The PEP function develops clinical and commercial fill/finish processes, device/combination product assembly processes, and packaging for biopharmaceutical products in the AstraZeneca Biologics portfolio. The Senior or Principal Scientist/Engineer is a project and technology leadership role within the PEP team, leading process development and tech transfer teams, and driving innovation and capability build for the team. This position requires effective collaborative interactions with project team members, internal/external manufacturing sites and suppliers. Prior experience working with pharmaceutical and manufacturing process development are essential. This individual must be able to work effectively in a matrix environment and be able to influence internally and externally.
Main Duties & Responsibilities:
- Lead late-stage and commercial technical transfers to internal facilities and contract manufacturers. Organize an internal sending unit team including development functions (device, analytical, packaging, formulation, fill and assembly process SMEs), supply chain, project management and QA.
- Lead Quality Risk Management efforts on projects, develop risk-based characterization and validation strategies for manufacturing processes. Propose general working strategies and risk-based project strategies that meet requirements of product quality, microbial control and sterility assurance, cGMP, as well as timeline and budget constraints.
- Drive a culture of innovation, scientific strength and technical rigor within Development teams. Provide technical and strategic leadership to project teams, junior staff, and the broader Development organization.
- Drive strategic thinking on drug product process aspects of novel therapy projects. Provide knowledgeable input on design for manufacturing, equipment vendor selection, manufacturing site capabilities, project lead time and budget estimates. Build Pilot Lab capabilities required for novel therapy process development.
Education & Experience Requirements:
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 or MS with at least 10 years of experience, or a PhD with 6 or more years of experience.
The candidate should have capability, skill and/or knowledge in most of the following areas:
- Biopharmaceutical / combination drug product development
- Knowledge of fill-finish unit operations such as filtration, mixing, and aseptic filling.
- Tech Transfer of pharmaceutical processes
- QbD, experimental design, statistics, data analysis
- Leadership, communication ability, and ability to influence
- Technical writing and documentation
Knowledge in the following subjects is desireable:
- Cell and gene therapy
- Regulatory guidance related to biologics, cell and gene therapy, aseptic processing, validation, cGMP, and combination products
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 https://careers.astrazeneca.com/bpd
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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.