某多肽Biotech公司
CMC总监
医疗医药
生物/制药/化工
上海
5-10年
博士
面议
职位描述
Job Description:
1. Manage CMC activities for Peptide-Drug Conjugates (PDCs), including process development, technology transfer, scale-up.
2. Lead the CMC stage of PDC projects, coordinating cross-functional efforts to ensure timely progression.
3. Drive project execution by planning, risk management, and resource allocation to maintain project momentum.
4. Oversee the production process and resolve daily operational issues.
Qualifications：
1. PhD in Chemistry, Biochemistry, Chemical Engineering, or a related field.
2. At least 8 years of CMC management experience in peptide drugs; PDC CMC experience preferred.
3. Hands-on experience spanning IND submission through clinical phases.
4. Knowledge of drug regulations (ICH, GMP, FDA); overseas registration experience is a plus.
5. Strong leadership, execution, and communication skills.
6. Detail-oriented and analytical, with the ability to identify and mitigate risks.
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