锦鲤求职岗位描述
Position Summary
WXPD-AS team at Wuxi city is seeking a skilled and highly motivated candidate to fill a Senior Scientist position. This position is responsible for leading method development/optimization, evaluation and method transfer, ensuring phase-appropriate bioactivity methods and testing strategies are established for product release/stability and characterization testing, supporting regulatory submissions and overseeing the product quality of monoclonal antibodies, bispecific monoclonal antibodies, ADC, etc. The candidate will work in a highly collaborative environment to utilize skills in partnership with internal and external experts.
Job Responsibilities
Lead a team of scientists to support a broad range of biologic projects, from IND to BLA, ensuring high-quality project execution and on-time delivery.
Drive assay strategy development to support product characterization, release testing, stability studies, comparability assessments, and regulatory submissions.
Oversee all aspects of function characterization work of protein therapeutics, including but not limited to a strong understanding of biomolecule “MoAs” such as cell/protien based binding assays, anti-proliferation assays, ADCC&CDC, cellular signal transduction/apoptosis/killing assays, etc.
Lead technical investigations, method troubleshooting, and root-cause analysis for critical project challenges
Establish platform capabilities, SOPs, and best practices to drive scientific excellence and operational efficiency.
Mentor and develop scientific talent, fostering a culture of innovation, accountability, and continuous improvement.
Qualifications
Ph.D. in Biology, Immunology, Cell Biology, Pharmaceutical Sciences, or a related field
Minimum 3 years of industry experience, including significant experience in potency assay development and characterization.
Excellent analytical mindset and skills including hands on experience with bioassays/immunoassays; such as Binding Activity, Bioassays, Effector-function, and cell-based assay.
Scientific understanding of bioassay/immunoassay technologies and applications
Familiarity with regulatory filings such as IND, IMPD, and BLA
Familiarity with relevant regulatory guidance documents (ICH, USP, CFR, general guidance)
Strong problem-solving and troubleshooting skills, capabilities in experimental design and execution, ability to work on multiple projects simultaneously, as well ability to work independently and collaborate cross-functionally