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Senior Manager, R&D DMPK

MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, 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.
We're 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 pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And 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.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
The Clinical Pharmacology & DMPK (CPD) Department is seeking a highly motivated individual with established experiences in regulated bioanalysis to build and lead a bioanalytical group in China. The scientist functions as a group leader to provide regulated bioanalysis support for pharmacokinetic, immunogenicity and pharmacodynamics biomarker assessment of biotherapeutic products in clinical studies conducted in China. The role will be based in our South San Francisco site for the initial 3 months for training, then will be based in Shanghai.
Major Duties and Responsibilities:
Serves as a group leader for a newly-established bioanalytical group in China
Is responsible for assay transfer/optimization, assay validation, regulated clinical sample analysis, data reporting, preparation of bioanalytical reports in support of clinical studies in China
Contributes to the setup of a regulated bioanalytical laboratory
Interacts with local regulators to ensure lab compliance and to support lab inspections
Hires, trains and supervises junior scientists
Manages resources and timelines to ensure timely delivery of results for clinical decision-making
Works with GMD team in China to provide bioanalytical support for clinical studies
Collaborates with bioanalytical scientists in US or UK for successful method transfer, troubleshooting, validation, sample analysis and data reporting
Contributes to regulatory submissions in China
Experience:
Good knowledge and established experience in regulated bioanalysis for pharmacokinetics and immunogenicity
Prior experience and understanding of regulatory requirement for method development and validation
Strong expertise in immunoassay development, validation and bioanalysis
Experience with working in cross-functional teams
Special Skills/Abilities:
Experience with assay development and validation for pharmacokinetics and immunogenicity
Excellent interpersonal, organization and communication skills
Ability to work in a team environment
Ability to lead junior scientists
Familiarity of GLP/GCP regulations
Fluent in Chinese and English
Job Complexity:
Multiple concurrent projects/tasks are expected and the ability to prioritize projects and time to meet project timelines are essential
Effective in working with cross-functional teams
Effective in supervising junior associates
Education:
BS, MS or PhD in a relevant field in the biological sciences
Minimum of 2-5 years industry experience in regulated bioanalysis
Next Steps ? Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience ? it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.



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