药明生物
分析项目管理
岗位职责
Work Scope
Work as analytical functional lead to support full-life-cycle CMC projects, including providing analytical strategy based on the understanding of complex molecule, process, and method; timeline management; batch release/stability support; cross-functional support and feedback to facilitate process development.
Provide scientific guidance on method development, comparability, release testing, and stability studies.
Coordinate analytical activities across multiple functions to ensure timely delivery of project milestones.
Identify project risks, develop mitigation plans, and proactively manage analytical timelines and deliverables.
Support overall CMC development strategies and contribute to cross-functional project planning.
Collaborate closely with process development, formulation, manufacturing, quality, regulatory, and other technical functions.
Present project progress, analytical strategies, and scientific findings to clients and stakeholders.
Interpret analytical data and provide scientifically sound recommendations to support critical development decisions.
Apply a strong understanding of protein characterization, product quality attributes, and analytical technologies to solve technical challenges.
Drive continuous improvement initiatives to enhance operational efficiency, analytical workflows, and project execution.
Participate in knowledge sharing, technical mentoring, and team development activities.
Contribute to standardization, platform development, and process optimization within the organization.
Contribute to preparation and review of regulatory submissions, including IND, BLA, and other health authority filings.
Author and review analytical sections of technical reports, regulatory documents, protocols, and scientific justification
任职要求
Master's degree or above in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or other relevant scientific disciplines.
2-3 years of relevant industry experience in biologics analytical development, characterization, or CMC development.
Overseas education or international research experience is preferred.
Hands-on experience in analytical method development, qualification, and testing for biologics is preferred.
Familiarity with analytical technologies such as: HPLC/UHPLC, Capillary Electrophoresis (CE), Mass Spectrometry (MS), Spectroscopic and biochemical characterization techniques.
Understanding of protein characterization, product quality attributes, and analytical lifecycle management is highly desirable.
Familiarity with regulatory requirements for biologics development and analytical CMC activities.
Experience supporting regulatory submissions (e.g., IND, BLA) is preferred.
Excellent written and verbal communication skills in both Chinese and English.
Strong presentation, stakeholder management, and cross-functional collaboration skills.
Ability to effectively communicate with clients and external partners.
Demonstrated scientific research capability with publications in peer-reviewed international journals.
Ability to independently analyze complex data, draw scientific conclusions, and communicate findings effectively.
Strong project management and organizational skills.
Ability to work effectively in a fast-paced and dynamic environment. Self-motivated, proactive, and results oriented. Strong problem-solving ability and resilience under pressure.
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