VACCINE CMC LEAD (Chemistry, Manufacturing and Controls)
Shanghai, 31
IDj-45254Posted7/10/2024
Opportunity at a leading global biologics services provider! For either Suzhou / Shanghai offices. 75000-110000 Chinese Yuan Renminbi Monthly. Recruiting worldwide.
Our client is a leading global biopharmaceutical company dedicated to providing end-to-end solutions for the discovery, development, and manufacturing of innovative biologics. With a strong commitment to advancing healthcare worldwide, our client seeks a talented and experienced Vaccine CMC Lead to join their dynamic team in China.
Lead and oversee the development and implementation of Chemistry, Manufacturing, and Controls (CMC) strategies for vaccine programs.
Collaborate with cross-functional teams to ensure successful execution of CMC activities, from early development to commercialization.
Provide technical expertise in the manufacturing process, ensuring compliance with regulatory requirements and industry standards.
Act as the primary point of contact for CMC-related communications with regulatory agencies.
Manage external collaborations and partnerships related to vaccine CMC.
Ensure timely and high-quality delivery of CMC documentation for regulatory submissions.
Qualifications
Education: Ph.D. in a relevant scientific discipline (negotiable).
Experience: Minimum of 5 - 10 years of experience in vaccine CMC development, with a proven track record in leading successful programs.
Language Skills: Proficient in both English and Chinese (written and spoken).
Regulatory Expertise: In-depth knowledge of regulatory requirements for vaccine development in China and globally.
Technical Skills: Strong background in bioprocess development, technology transfer, and manufacturing of vaccines.
Leadership: Demonstrated leadership skills in managing cross-functional teams and external collaborations.