Sample Manager/ Analytical Quality and Logistics
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 ground breaking 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 growing collaboration between teams.

Summary of the group

The Analytical Sciences GMP department within Research and Development is

responsible for analytical support of clinical stage biopharmaceutical products in

accordance with GMP regulations. This includes management of lot release and stability

programs, reference standards and critical reagents, analytical tech transfer, and sample

chain of custody. Members of the Analytical Sciences GMP department work closely

with Analytical Sciences development personnel, Clinical Supply Chain, CMC, and

Quality assurance across all stages of clinical development (from pre-IND to BLA

(Biologics License Application))

Responsibilities:

• Independently performs sample management responsibilities, such as sample receipt,

inventory, and distribution, between R&D departments to enable CMC activities

• Acts as a point of contact and subject matter expert for the Laboratory Information

• Management System (LIMS) including training of personnel, troubleshooting user

issues, and recommending improvements to the system.

• Collaborates with internal and external customers to coordinate sample distribution

and enable testing for critical business processes such as method qualification and

technology transfer.

• Performs testing and reviews data for biopharmaceutical products including final drug

substance and drug product according to written procedures following cGMP

practices

• Authors, revises, and/or reviews SOPs (Standard Operating Procedures), protocols,

reports, and other relevant documentation

• Maintains laboratory and equipment in accordance with written procedures
• Participates in quality investigations (such as deviation and OOS (Out of

Specification)), as needed

• Prepares reports and presentations for internal meetings and supports regulatory

filings

• Participates in and/or leads cross-functional teams

Education & Experience Requirements

Bachelor's degree with 2+ years of industry experience.

Required Skills

• Prior experience in a laboratory environment and familiarity with laboratory
• practices and safety requirements is required.
• Prior experience with some analytical methods used for characterization of
• biopharmaceutical products, including total protein analysis
• Prior experience with stability sample handling (aseptic aliquoting and sample
• distribution) in GMP environment.
• Prior experience with Labware Laboratory Information System (LIMS) and training
• with automated sample management equipment.
• Familiarity with cGMP, ICH and USP/EP requirements is desirable
• Previous experience in a Quality Control environment is desirable
• Ability to work well independently and in teams across multiple functional areas
• Ability to work well with temperature provided in our storage units (this may
• include temperature ranging from -198°C to 40°C) using proper PPE.
• Must be physically sound, able, and willing to lift to 50 pounds as part of job
• requirement.

Solid understanding of Microsoft Excel, Word, PowerPoint, OneNote, and Microsoft

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/

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

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

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.

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