职位编号Job Code: CNCMC03
职位 Position: Formulation Manager
部门 Department: Biologics CMC
汇报关系 Reports to: Director of QA/QC
办公地点 Location: Connect Taicang Office
职位目标 Purpose or Objective of Position:
Complete the work related to the company’s biomacromolecule pharmaceutical preparations.
主要职责 Key Responsibilities：
- Responsible for literature research, program design and optimization of formulations of biological products;
- Responsible for the screening of biological product formulations and formulation process research;
- Responsible for the preparation influencing factor test, accelerated stability test and long-term stability test research of biological products and related preparation sample testing;
- Responsible for the establishment and data writing of SOP documents related to preparations in new drug applications;
- Participate in the screening and inspection of formulation service providers.
- Complete various tasks assigned by superiors.
Be able to independently complete the design, screening, and preparation process research of biological product preparations, complete the stability plan design of preparations and related experimental work, and complete the establishment of preparation-related SOP documents and data writing.
职位要求 Job Requirements:
- Bachelor degree or above in formulations, biotechnology related majors; more than 3 years of work experience in formulation research and development;
- Familiar with the domestic drug research and development registration process, able to independently prepare the registration application materials of biological drugs;
- Able to independently complete the formulation process design of the biological drug preparation process, and guide and independently carry out the research on the formulation process of the formulation;
- Rich in pharmaceutical preparation theory and experience, good experimental operation ability, skilled in the use and daily maintenance of pharmaceutical preparation equipment;
- Have good English, computer application ability and literature retrieval ability;
- Good at learning and accepting new knowledge, strong sense of responsibility, and good teamwork spirit.
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