锦鲤求职岗位描述
Job Summary
The position is responsible for providing scientific and technical leadership in laboratory investigations, deviation investigations, assay performance monitoring, and analytical method lifecycle activities. The position also serves as a technical resource for resolving complex analytical challenges, improving assay performance, evaluating emerging analytical technologies, and collaborating with internal functions, external partners, and clients to ensure the timely and successful completion of analytical projects.
Essential Duties and Responsibilities
Lead or support laboratory investigations, including the development, drafting, review, and approval of investigation plans and reports.
Lead or support deviation investigations, including the drafting, review, and approval of deviation investigation reports.
Review assay failures, identify recurring or potential failure modes, summarize contributing factors, and recommend appropriate corrective or preventive measures.
Perform periodic assay performance reviews by compiling and evaluating historical analytical data.
Draft and review technical and quality documents, including standard operating procedures, analytical methods, method transfer protocols and reports, method qualification protocols and reports, and method validation protocols and reports.
Ensure that technical documents are scientifically accurate, complete, consistent, traceable, and compliant with applicable cGMP and regulatory requirements.
Communicate and collaborate with internal stakeholders, external partners, and clients to ensure the timely completion of method qualification, validation, and transfer activities.
Provide technical leadership in the resolution of complex analytical issues and support cross-functional scientific decision-making.
Support analytical method optimization and the evaluation, introduction, and implementation of new analytical technologies.
Lead the periodic review and update of templates used for analytical method transfer, method qualification, method validation, Analytical Method Protocols or Plans, and laboratory investigation reports.
Experience
Experience working in a Quality Control laboratory, analytical development laboratory, or other relevant GMP-regulated environment is preferred.
Knowledge and hands-on experience in at least one of the following analytical areas is required:
Biochemical assays: ELISA, cell-based assays, qPCR, Western blot, enzyme activity testing, or related techniques.
Separation assays: HPLC/UPLC, CE-SDS, iCIEF, or related separation techniques.
Biophysical assays: Mass spectrometry (MS), UV spectroscopy, or related biophysical analytical techniques.
Experience in one or more of the following areas is preferred:,
Laboratory investigation and deviation investigation
Analytical method development or optimization
Analytical method transfer, qualification, or validation
Assay failure review and troubleshooting
Assay performance monitoring and statistical data analysis
Preparation and review of cGMP technical documentation
Collaboration with internal functions, external partners, or clients
Qualifications
Bachelor's or Master's degree in Analytical Chemistry, Biochemistry, Microbiology, Biology, Molecular Biology, Biological Engineering, or a related scientific discipline.
Relevant experience in pharmaceutical, biopharmaceutical, biotechnology, or GMP Quality Control is preferred.
Good understanding of cGMP requirements, data integrity principles, and GMP documentation practices is preferred.
Behavioral Competencies
Scientific Rigor: Applies sound scientific principles and objective evidence when evaluating analytical issues and drawing conclusions.
Critical Thinking: Analyzes complex information systematically, challenges assumptions appropriately, and identifies scientifically defensible solutions.
Problem Solving: Proactively identifies potential causes of analytical or process-related issues and develops practical, risk-based solutions.
Accountability: Takes ownership of assigned responsibilities and follows through on commitments in a timely and reliable manner.
Communication: Communicates scientific and technical information clearly, accurately, and appropriately for different audiences.
Continuous Learning: Actively expands scientific, regulatory, statistical, and technical knowledge and applies new knowledge to improve work quality.