锦鲤求职岗位描述
This position is for WuXi Vaccines.(苏州药明海德）
In the past decade, vaccines have become crucial in addressing global health challenges and meeting the growing demand for healthcare. The purpose of vaccine analytical development is to simplify the complex clinical effects of vaccines into analytical attributes at cellular or molecular levels, thereby defining vaccine quality. Through rigorous science, we improve disease prevention and treatment, benefiting millions of lives.
WuXi Vaccines is China's largest contract research and manufacturing organization (CRMO) for vaccine biologics, offering an ideal platform for work, learning, and growth.
Responsibilities:
Innovation skills and leadership in development of immunoassays and cell-based assays in support of vaccine or other biotech product portfolio.
Ensure compliance to regulatory requirement, including instrument maintenance, personnel training, document drafting, review and archiving.
Lead lab investigations, OOS/OOT, deviations, CAPA and change controls; support quality system activities, audits, and regulatory inspections (NMPA/FDA/EMA).
Gradually manage a team of junior scientists to conduct analytical development, qualification / validation and sample testing for lot release, in-process, stability and R&D samples under a non-GMP or GMP environment until established as part of a clinical control system.
Execute routine GMP release and characterization testing
Transfer, training and trouble-shooting of pivotal analytics to collaborating QC labs
Draft and review regulatory submissions including INDs and BLAs. Interaction with regulatory agencies such as US FDA and China NMPA on a regular basis.
Represent the department in CMC team for selected projects.
Basic Qualifications:
Master or PhD in Analytical Chemistry, Biochemistry, Biotechnology, Cell Biology, Immunology or related field.
2-4 years (or a minimum of 6 years for Master’s degree holders) of industrial experience in functional biochemical, cell-based assay, and potency assay.
Strong working knowledge of regulatory requirement. Experience with the use of electronic lab notebooks.
Strong technical innovation and trouble-shooting skills in bioassay or immunoassay development, validation, and performance.
In-depth knowledge with PCR, ELISA, flow cytometry, cell signal transduction, immune regulation and mammalian cell culture.
Excellent spoken and written communication skills in English is a must.
Experience with regulatory filings preferred.
Job Function: R&D, Quality
Primary Location: China – Suzhou