We are seeking a highly motivated and independent Senior Scientist with hands-on experience in cell-based potency assays and process residual methods. As a Senior Scientist, you will lead the late-stage development, validation, and transfer of analytical methods needed to release and characterize our robust late-stage pipelines. This person will work closely with QC testing sites (internal or external), other GTO functions, R&D, Quality, Regulatory, and Supply Chain organizations.
In Biologics Global Technical Operations (GTO), we work closely with AstraZeneca's manufacturing network of internal sites and external manufacturing partners (CMOs), our colleagues in R&D, Quality, Regulatory, Supply Chain, and Commercial to provide technical expertise to ensure delivery of quality products to our patients and support our product pipeline.
Located at the Frederick Manufacturing Center is dedicated to building a culture of inclusion and collaboration. We host yearly Inclusion and Diversity conferences and have an employee resource group dedicated to promoting diversity and inclusion and improving employees' professional development through interactive and engaging events and initiatives.
Accountabilities:Responsible for execution of residual methods (such as HCP ELISA and HCD qPCR) and potency assays (cell-based and binding-based) to support method validation, transfer, and critical reagent qualification in support of our internal and external customers.Manage authoring, revising, and reviewing of technical documents, qualification protocols, SOPs, reports, and Certificates of Analysis as well as the coordination of all lab work necessary to complete qualifications on time.Perform routine administrative duties necessary to keep laboratory areas operational, safe, and compliant, such as logbook review, equipment preventive maintenance, general laboratory upkeep, and ordering.Maintain up-to-date familiarity with applicable regulations and regulatory guidance associated with analytical method design/transfer/validation requirements.To succeed in this role, you will need to be self-motivated, innovative, have strong technical and communication skills, and a deep understanding of potency and residual methods used to release biological products.Perform other duties as desired.Essential Skills/Experience:Degree in a scientific discipline with experience developing, validating, and transferring potency or residual methods within the biopharmaceutical industry:B.S with 5+ years of experienceM.S. with 3+ years of experiencePhD with 1+ years of experienceWell-developed understanding of molecular techniques, immunological assays, genetic modification, and cell engineering in industrial settings.Technical skills should include experience with many of the following: ELISA residual methods, basic molecular biology skills, aseptic techniques, cell culture, cell banking, binding potency, and cell-based potency assays.Desirable Skills/Experience:Experience working under GMP conditions is a plus.Technical knowledge of commercial biologics quality control testing for release, stability, and regulatory submission support preferred.Ability to work in a complex, dynamic, global environment, thinking strategically and balancing both long and short-term priorities.Ability to work on multiple projects and meet deadlines as needed; emphasis on results-oriented, strong planning and execution skills.When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Be welcomed into our inclusive network of diverse and high-performing teams. Have the support, trust, and respect to thrive here. Fair leadership, great workplaces, and energized teams who always have each other's back. For those with a shared drive and passion for impacting people's lives, experience a sense of belonging like no other.
Ready to make a difference? Apply now!
#J-18808-Ljbffr