Scientist I - Fill/Finish - BPD
AstraZeneca

Job Info

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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:

The PEP function develops Drug Product (DP) clinical and commercial fill/finish processes, device/combination product assembly processes, and packaging for biopharmaceutical products in the AstraZeneca Biologics portfolio.

Main Duties & Responsibilities:

1) Technical Leadership: Contribute to the operation of a fill-finish pilot laboratory with lab scale capabilities including vial and syringe filling, lyophilization, and device assembly. Develop risk assessment tools, study protocols and report templates. Mentor and teach process design, development and engineering concepts to staff members. Provide technical rigor in experimental design and data analysis across projects. Carry out ongoing academic, regulatory and vendor literature review, maintain cutting edge technical knowledge, and communicate findings to team.

2) Process Characterization: Perform risk analyses and conduct laboratory or engineering studies at manufacturing sites to characterize processes. Test, analyze and interpret a range of protein and peptide characterization assays (e.g. HPLC, UPLC, HIAC, MFI, cIEF). Design process steps, establish associated operational design space and control strategy. Support engineering and clinical fills at GMP fill-finish sites. Review and approve batch records, validation protocols, and other GMP documents. Provide on-site support of fills, provide support to investigations and evaluate non-conformances. Regulatory writing responsibilities include supporting clinical and commercial filings.

3) Tech Transfer: Assist or lead late-stage and commercial technical transfer of fill-finish processes to internal or contract manufacturing facilities for biopharmaceutical drug products. Serve on an internal sending unit team including development functions (formulation, process, device, analytical, packaging), operations, supply chain, project management and QA. Manage timelines and activities internally, communicate goals and track deliverables at the receiving site. Manage TT documentation effectively. Some travel is required (typically 5 - 15 trips per year) in the US and abroad.

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

Ph.D. with 0+ years OR Master's degree and 8+ years OR Bachelor's degree and 10+ years experience in the pharmaceutical industry as appropriate (biotechnology area preferred).

Suitable experience may include development of fill-finish, lyophilization, device assembly, or related processes. A high degree of self-motivation and technical rigor is required. Strong communication and technical writing skills are essential. Experience organizing and leading cross-functional teams is valuable. Though this position is in Development, we will consider strong candidates with GMP processing experience, e.g. in technical services, project management, QA or validation. We will also consider strong candidates from a device development or small molecule parenteral background.

Required Skills:

The candidate should have capability, skill and/or knowledge in most of the following areas:

• Biopharmaceutical drug product development
• Combination product and cGMP regulations
• Knowledge of fill-finish unit operations including formulation, mixing, filtration, fill and lyophilization
• Biopharmaceutical degradation pathways and mechanisms
• QbD, experimental design, statistics, data analysis
• Technical writing and documentation
• Ability to handle multiple ongoing work streams in an organized fashion

Desired Skills:

• Experience in vaccine development
• Experience with authoring regulatory documents

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 https://careers.astrazeneca.com/bpd

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