锦鲤求职岗位描述
This position is for WuXi Vaccines.(苏州药明海德）
We are seeking an experienced and highly motivated Principal Scientist to join our Analytical Development team. The successful candidate will provide technical leadership in analytical development, with a primary focus on HPLC and capillary electrophoresis (CE) methods for the characterization, release, and stability testing of biopharmaceutical products. This role requires strong hands-on expertise, independent scientific judgment, and the ability to mentor junior scientists while supporting efficient laboratory operations and continuous improvement.
Responsibilities:
• Lead the design, execution, and interpretation of analytical studies using HPLC (SEC, RP, IEX, etc.) and CE (CE-SDS, icIEF, etc.) to characterize and assess the quality of biotherapeutics.
• Develop, optimize, and qualify/validate analytics for product characterization, release, and stability testing, consistent with applicable regulatory expectations.
• Lead implementation, lifecycle management, and continuous improvement of platform analytical methods across the organization.
• Investigate and resolve complex analytical issues, applying sound scientific and statistical principles to identify root causes and effective solutions.
• Analyze, interpret, and document analytical data with a strong focus on data integrity, scientific rigor, and compliance with applicable quality standards.
• Author technical reports, analytical protocols, qualification/validation documents, and regulatory submission content; communicate results effectively to cross-functional teams and clients.
• Provide technical mentorship, training, and scientific guidance to junior scientists.
• Support lab operations, including instrument qualification and maintenance, analytical resource planning, and adherence to GMP/GLP, safety, and quality requirements.
• Collaborate closely with CMC, Process Development, Project Management, Regulatory Affairs, and other cross-functional teams to advance projects and meet milestones.
Qualifications:
• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline with 2+ years of relevant industry experience; M.S. with 6+ years; or B.S. with 8+ years of relevant experience.
• Strong hands-on expertise in HPLC and capillary electrophoresis, including techniques such as SEC, RP, IEX, CE-SDS, and icIEF.
• Strong track record in analytical procedure development, optimization, qualification, and validation for biopharmaceutical products.
• Proficiency with Empower or equivalent chromatography data systems for data acquisition, processing, and analysis.
• Strong understanding of physicochemical characterization of biotherapeutics and vaccines, including structural attributes, purity, heterogeneity, aggregation, charge variants, and molecular integrity.
• Broad knowledge of analytical characterization techniques and their application to critical quality attributes (CQAs) of biotherapeutics.
• Working knowledge of ICH, FDA, and EMA regulatory expectations and GMP/GLP laboratory practices.
• Experience with analytical procedure lifecycle management, platform methods, and laboratory/instrument management is preferred.
• Prior experience supporting or authoring regulatory submissions (e.g., IND, BLA) is highly desirable.
• Excellent scientific judgment, problem-solving, organizational, and communication skills.
• Demonstrated ability to independently manage multiple projects, prioritize competing activities, and deliver high-quality results in a fast-paced environment.
• Strong interpersonal and collaboration skills, with the ability to work effectively in a team-oriented, cross-functional environment.