-

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 screening ,

clinical 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. GMPSOPLead 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.

Masters 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. HPLCCEDSCBasic understanding of analytical instruments (e.g.,

HPLC ,

CE ,

DSC ) and hands-on experience with formulation-related equipment. Foundational data analysis capabilities . ICHGMPKnowledge of regulatory guidelines (e.g.,

ICH ,

GMP ) 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.