CMC Director 

Job Responsibilities:

1.Overall responsibility for the CMC project management of the company, including establishing and managing the CMC team, project initiation, formulation and update of timelines, development of CMC standards, organization of project meetings, tracking of project progress, guidance on project implementation, budget and cost management, etc.

2.Develop and implement CMC strategies for small molecule projects, establish standardized project management execution processes, improve systematic construction, and coordinate with external partners to meet regulatory, quality, and budget requirements.

3.Identify, select, and manage CROs and CDMOs, execute all CMC activities, including process development, scale-up, manufacturing, and analytical testing, to ensure consistency with project timelines and quality standards. Provide end-to-end technical guidance to ensure the process is efficient, stable, and scalable.

4.Lead collaborations with CRO/CDMO to prepare and review the CMC sections of regulatory submission documents (e.g., IND, NDA), ensuring compliance with FDA, EMA, and other global regulatory standards.

5.Negotiate contracts, manage budgets, and monitor performance indicators of CRO/CDMO partnerships to ensure cost-effective and high-quality deliverables.

Maintain effective and good communication with internal and external clients to efficiently advance projects.

Job Requirements:

1.Master's or doctoral degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related fields, with excellent English reading and writing skills.

2.Familiar with GMP, ICH guidelines, and global regulatory requirements for CMC, with experience in regulatory submissions (e.g., IND, NDA) and extensive experience in interacting with global regulatory authorities (NMPA, FDA, EMA, etc.).

3.Proficient in the full-process development of CMC for small molecule drugs, with a successful track record in supervising drug substance synthesis, formulation development, and analytical testing through external partners.

4.Exceptional CRO/CDMO relationship management skills, outstanding negotiation, communication, and interpersonal skills, and the ability to effectively mediate with internal stakeholders and external partners.

5.5-10+ years of team and project management experience, with a focus on driving results and cultivating a positive team spirit.

Work Location: Yantai