???????????????????,?????????????????????????????????????????????????????????????????????,????????????????,?????????????Responsible for formulation-related activities throughout the full lifecycle of biologics, spanning pre-IND application, early clinical phases, pivotal clinical phases, and post-marketing stages. Core responsibilities include formulation development, pilot-scale batch production, process scale-up and technology transfer, and commercial manufacturing support, ensuring seamless execution of biologics R&D and production to drive project advancement and regulatory submissions.
R&D & Regulatory Submissions
??????????????????????,?????/??????????????,??????????;Conduct formulation screeningclinical formulation process development, and pilot-scale production; design stability study protocols for non-clinical/clinical in-use samples; author formulation-related sections of regulatory submission documents.?????????????????,?????????????????????,??????????????Perform process characterization, design process validation protocols, complete stability comparability studies for pivotal clinical and commercial formulations, and participate in defining formulation-related parameters for product labeling.Technology Transfer & Manufacturing Support
??????/????????????,??????????;Conduct localization quality comparability studies for imported excipients/packaging materials, and draft alternate source qualification reports.??????GMP???????????,??????????????,??????SOP?Lead formulation technology transfer from R&D to GMP manufacturing, resolve deviations during first GMP production batches, and establish production monitoring SOPs.???????,??????????????????????,??????????;Review batch records, lead investigations into deviations (e.g., lyophilization cycle optimization, filling accuracy deviations), and conduct supplementary stability studies.??????????????????????,????????;Execute supportive studies for changes (e.g., excipient supplier change, manufacturing site transfer), and draft change control submission documents.??????????????,??????????????Analyze formulation-related customer complaints, provide technical solutions, and deliver internal training.???????,?????????????;Master's degree or above in Biopharmaceuticals, Pharmaceutics, or related disciplines.
- ?????????????,????????????,????????????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
?????????????,????????????????;Familiar with fundamentals of biologics formulation development, including lyophilization process and aseptic filling techniques.????HPLC?CE?DSC?????,?????????????Basic understanding of analytical instruments (e.g., HPLCCEDSC) and hands-on experience with formulation-related equipment.Foundational data analysis capabilities??ICH?GMP?????????????Knowledge of regulatory guidelines (e.g., ICHGMP) and industry technical standards.?????,??????????????;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.