Associate Director CMC Manufacturing Technologies

Shanghai, China | full time | Job ID: 11697

The Associate Director CMC Manufacturing Technologies is a key member of a global CMC team and will be responsible for leading tech transfer processes from one CDMO to another across different continents during the clinical stage. This involves collaborating with internal and external teams to ensure a seamless and efficient technology transfer. The role also includes serving as the operative CDMO manager, overseeing day-to-day operations at the CDMO, and ensuring compliance with company policies and business requirements. Additionally, the Associate Director CMC Manufacturing Technologies will lead CMC due diligence activities, ensuring a comprehensive evaluation of all aspects of the development program and appropriate identification and reporting of risks. Your main responsibilities are:

• Lead the tech transfer of clinical-stage processes from one CDMO to another, including project planning, risk assessment, and oversight of transfer activities
• Develop and maintain project timelines, budgets, and resource plans for tech transfer projects
• Collaborate with internal and external teams to ensure successful technology transfer
• Serve as the project-specific primary point of contact for the CDMO, managing the onboarding and day-to-day operations and ensuring that all activities are in compliance with company policies and contractual requirements (scope of work)
• Establish and cultivate strong relationships with CDMO partners, fostering effective communication and collaboration. Represent CMC internally in the Supplier Relationship Team.
• Lead CMC due diligence teams during the evaluation of China-based development programs, working closely with cross-functional teams to evaluate all aspects of the program and identify and report risks appropriately.
• Provide regular updates to senior management on project status, risks, issues and CDMO performance

What you have to offer:

• Bachelor's degree in a scientific or engineering field, advanced degree preferred
• Minimum of 7 years of experience in pharmaceutical or biotech industry, with at least 5 years of experience in technology transfer and/or CDMO management
• Strong project management skills, with experience leading cross-functional teams and managing budgets and timelines
• Knowledge of GMP regulations and requirements for biopharmaceutical manufacturing
• Expertise in the development and manufacturing of protein-based therapeutics and ADCs
• Excellent communication and interpersonal skills, with the ability to build strong relationships with internal and external stakeholders
• Ability to work independently and prioritize tasks in a fast-paced, dynamic environment
• Strong intra-cultural expertise and fluency in English, both written and verbally

Your benefits and remuneration:

If the position is filled in the US, the Expected Pay Range is XXX,XXX/year to XXX,XXX/year + benefits, annual bonus & equity (bonus and