CMC Lead

该职位来源于猎聘 Job Description

• Provide technical oversight of contracted projects, effectively partner with project management team to support biologic product development activities across all phases. Collaborate with functional teams to ensure successful execution and delivery of project milestones on time and within budget.
• Collaborate with client and functional teams to develop the project plan and execution strategy to align with client's objectives and company's overall strategy
• Promote efficient communications across key stakeholders to ensure transparency on project status and alignment with overall program plans and timelines. Provide solutions to resolve challenges and issues as needed.
• Build effective communication with clients to ensure the alignment between project team and clients.
• Support business development activities, including proposal writing team to develop new clients, and maintain existing clients.
• Other tasks assigned by leadership. Qualification：
• Advanced degree (PhD or MS) in biology/biochemistry, Bio Engineering or related field with 10+ years of relevant industry experience, working experience in biopharmaceutical CDMO environment is preferred.
• Strong understanding of cGMP/ICH guidelines and regulatory requirement for biologic CMC development across all phases
• Strategic view and leadership abilities with strong problem solving and decision-making skills.
• Good communication and coordination skills, strong independent working ability and team spirit.
• Ability to communicate with internal functional teams in Mandarin.
• Base Western US or Europe