Hengrui Pharma
Analytical Method Development & Validation
CMCDevelop and validate specific analytical methods (e.g., physicochemical analysis, structural characterization, purity/impurity testing, potency/stability evaluation) per CMC strategy, supporting drug substance/drug product quality control during process development.
Conduct analytical activities for process optimization and validation, ensuring method suitability and reliability, and providing scientific justification for process changes.
Design and execute drug stability studies to evaluate long-term stability under various conditions, supporting shelf-life determination.
Compliance & Data Management CMCICH QFDAEMACMCEnsure all analytical activities comply with domestic and international CMC regulations (e.g., ICH Q-series guidelines, FDA/EMA CMC guidance). Manage experimental data collection, organization, analysis, and reporting, ensuring data accuracy and traceability.
Explore and implement novel analytical technologies to improve efficiency and accuracy; continuously optimize existing methods. CMCCollaborate with CMC teams to resolve technical challenges; participate in internal training and knowledge sharing.
Masters degree or above in Biochemistry, Molecular Biology, Pharmacy, Analytical Chemistry, or related disciplines.
Research projects involving analytical testing, with familiarity with relevant instrument operations.
Strong English proficiency (listening, speaking, reading, writing), capable of fluently interpreting English technical literature and conducting technical communication with international peers.
///Shanghai / Suzhou / Guangzhou / Lianyungang
1.HPLC Experimental Techniques : Proficient in biologics analytical techniques (e.g.,
HPLC ,
mass spectrometry ,
bioactivity assays ), capable of independently designing and executing experimental protocols. 2. Data Analysis : Basic data analysis capabilities, proficient in using software for data processing and interpretation.
Strong learning agility and deep interest in biopharmaceutical process development. Systematic thinking and data analysis skills, adaptable to fast-paced R&D environments. Independent problem-solving skills and cross-departmental collaboration mindset.
Compliance & Data Management CMCICH QFDAEMACMCEnsure all analytical activities comply with domestic and international CMC regulations (e.g., ICH Q-series guidelines, FDA/EMA CMC guidance). Manage experimental data collection, organization, analysis, and reporting, ensuring data accuracy and traceability.
Explore and implement novel analytical technologies to improve efficiency and accuracy; continuously optimize existing methods. CMCCollaborate with CMC teams to resolve technical challenges; participate in internal training and knowledge sharing.
Masters degree or above in Biochemistry, Molecular Biology, Pharmacy, Analytical Chemistry, or related disciplines.
Research projects involving analytical testing, with familiarity with relevant instrument operations.
Strong English proficiency (listening, speaking, reading, writing), capable of fluently interpreting English technical literature and conducting technical communication with international peers.
///Shanghai / Suzhou / Guangzhou / Lianyungang
1.HPLC Experimental Techniques : Proficient in biologics analytical techniques (e.g.,
HPLC ,
mass spectrometry ,
bioactivity assays ), capable of independently designing and executing experimental protocols. 2. Data Analysis : Basic data analysis capabilities, proficient in using software for data processing and interpretation.
Strong learning agility and deep interest in biopharmaceutical process development. Systematic thinking and data analysis skills, adaptable to fast-paced R&D environments. Independent problem-solving skills and cross-departmental collaboration mindset.