Here at AstraZeneca you'll have the opportunity to make a difference in people's lives every day! As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As an Assoc Principal Scientist in Microbial Sciences in Gaithersburg, MD, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
The Microbial Sciences group at AstraZeneca is constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're utilizing our expertise in microbiology and immunity to enable novel therapeutic approaches to prevent and treat infectious disease. We're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
The Associate Principal Scientist will oversee development, validation and implementation of clinical assays at academic laboratories, contract research organizations (CROs), diagnostic labs and partners to support the development of AstraZeneca's vaccine and biologics drug candidates.
Main Duties and Responsibilities
- Selecting and providing scientific and technical oversight of CROs, diagnostic companies and academic partners.
- Provide leadership and work closely with internal Subject Matter Experts in infectious diseases and immunology to establish standard requirements for outsourced biomarker assays (trending, SOPs, QC/QA, CAPA's and investigations) and methods to assure that strategic scientific and relationship management best practices are employed throughout product development and commercialization.
- Work with Translational Medicine scientists, technical staff, and Project Teams to effectively manage molecular epidemiology and surveillance studies and biomarker testing that adheres to relevant laws, regulations, guidelines, and company policies
- Develop and manage relationships with CROs, academic laboratories, vendors, diagnostic companies to influence decisions both within and outside of Translational Medicine
- Direct operational implementation of key projects and assays at external laboratories
- Developing project plans, timelines and governing change order management, project, quality and the timely achievement of deliverables.
- Bachelors plus 13-15 yrs, Masters plus 10-13 yrs or a PhD plus 5-8 yrs relevant experience in industry or academia
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- Degree in Biochemistry, Microbiology, Virology, Immunology or a related area
- Experience with a majority of the following techniques: PCR, sequencing, serology, immunoassays, cell-based assays, and Data Analysis
- Familiarity with ICH, MHRA, EMEA, FDA, GCP, GLP guidelines
- Strong organization, analytical, problem solving skills
- Excellent oral, written and presentation communication skills
- Proven ability to take on multi-tasks and to execute them effectively with a good sense of priority under limited guidance
- Project management experience would be desirable.