Senior Manager, Vaccines and Immune Therapies
AstraZeneca

Gaithersburg, Maryland

This job has expired.


Senior Manager - Vaccines and Immune Therapies

Level D

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 Translational Scientific Management, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.

The Translational Science 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 diseases. 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 successful candidate for this role will manage the development, validation, and implementation of clinical assays at academic laboratories, contract research organizations (CROs), diagnostic companies, and partners to support the development of AstraZeneca's vaccine and biologics drug candidates.

Main Duties and Responsibilities

• Provide technical oversight of CROs, diagnostic companies, and academic partners.

• Work closely with internal Subject Matter Experts in Vaccines and Immune Therapies to establish standard requirements for outsourced biomarker assays (trending, SOPs, QC/QA, CAPAs, and investigations) and methods to assure that scientific and vendor relationship management best practices are employed throughout product development and commercialization.

• Work with Translational Leads, technical staff, and project teams to effectively manage 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.

Education ( Align with Level D)

• Bachelors plus 13-15 yrs, Masters plus 10-13 yrs, relevant experience in industry or academia

Requirements:

• Degree in Biochemistry, Microbiology, Virology, Immunology or a related area

• Experience and/or familiarity with operational aspects of drug development and clinical studies

• Familiarity with ICH, MHRA, EMEA, FDA, GCP, GLP guidelines

• Strong organization, analytical, problem-solving skills

• Excellent oral, written, and communication skills

• Demonstrated 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.

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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.


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