Associate Scientist - Analytical Quality, Bioassay Development

AstraZeneca PLC
Gaithersburg, MD
Sep 12, 2021
Sep 15, 2021
Full Time
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 Analytical Sciences GMP group 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. The team engages with analytical development and manages assays across multiple analytical disciplines including: chromatography, electrophoresis, immunoassay, bioassay and device functionality methods. 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 (pre-IND to BLA). Main Duties & Responsibilities In this role the Associate Scientist will carry out bioanalytical cell-based assay testing of recombinant protein therapeutics under cGMP. In this role you will make detailed observations, analyze data, interpret results, and exercise appropriate technical discretion in the design, execution, and interpretation of experiments in a relatively independent manner. This person may be involved in the qualification and validation of cell-based bioassays for biological characterization and testing of biopharmaceutical products, and assist in assay investigations and troubleshooting. * Prepare reagents/solutions * Order and stock reagents and lab supplies * Perform mammalian cell culture, cell-based assays, and routine lab equipment maintenance * Review testing data and logbooks * Contribute to preparation of technical reports, SOPs and technical summaries for meeting presentation. * Assist/lead investigation for non-conformances and assist/coordinate equipment validation with different departments. * Present findings at internal meetings. * Receive general instructions from supervisor for routine work and new assignments. (Supervision is not required, level of independence is medium) REQUIREMENTS Education: BS/MS in Biological Sciences Minimum of a BS degree with some relevant experience preferred Experience with mammalian cell culture is required Experience with cell-based assay in a GLP/GMP industry environment is a plus ADDITIONAL NOTES The successful candidate must have excellent written and oral communication skills, good time management and outstanding multi-tasking abilities, and the ability to work in a cGMP environment and a fast-paced team-centered setting. Mammalian cell culture; Cell-based assay in 96-well format; TrackWise, DLIMS/LIMS, and SoftMax Pro; Automated cell counter and plate reader; Detail oriented; Good documentation. 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 Follow AstraZeneca on Facebook Follow AstraZeneca on Instagram Date Posted 27-Jul-2021 Closing Date 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.#06022021