Sample Manager/ Analytical Quality and Logistics - Gaithersburg, United States - AstraZeneca
Description
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 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,
- Management System (LIMS) including training of personnel, troubleshooting user
- Collaborates with internal and external customers to coordinate sample distribution
technology transfer.
- Performs testing and reviews data for biopharmaceutical products including final drug
practices
- Authors, revises, and/or reviews SOPs (Standard Operating Procedures), protocols,
- Maintains laboratory and equipment in accordance with written procedures
- Participates in quality investigations (such as deviation and OOS (Out of
- Prepares reports and presentations for internal meetings and supports regulatory
- Participates in and/or leads crossfunctional 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
- Prior experience with some analytical methods used for characterization of
- Prior experience with stability sample handling (aseptic aliquoting and sample
- Prior experience with Labware Laboratory Information System (LIMS) and training
- 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
- Must be physically sound, able, and willing to lift to 50 pounds as part of job
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 lifechanging 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 biopharmaceutical 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 t
More jobs from AstraZeneca
-
Material Handler II
Frederick, United States - 3 weeks ago
-
District Sales Manager, Cvrm Attr Team
Washington, United States - 2 weeks ago
-
Process Safety Management Regional Lead
Coppell, United States - 3 weeks ago
-
Associate Scientist
Gaithersburg, United States - 1 week ago
-
Associate Director, Brand Communications
Gaithersburg, United States - 1 week ago
-
Product Manager
Gaithersburg, United States - 2 weeks ago