The client is a health solutions company that specializes in providing a comprehensive, integrated and highly customized range of services for the discovery, development and manufacturing of biologics. They are a leading global open-access biologics technology platform in the world offering end-to-end solutions to empower anyone to discover, develop and manufacture biologics from concept to commercial manufacturing. They provide the world with the ONE true single-source approach that saves their clients critical time and money. 

The Director of CMC Management​ in ShangHai city will have the opportunities to 

• Broaden personal knowledge and experience in the field of biologics
• Integrate cross-functional knowledge in real life drug development and commercialization process
• Develop leadership skill to facilitate contributions from different functions
• Develop well-around knowledge in preparation for executive opportunities

Responsibilities 

• Provide project leadership supporting IND enabling and late stage product development CMC activities.
• Participate and show leadership in establishing Biologics CMC strategies and recommendation in supporting all ongoing projects in CMC development.
• Leading CMC projects with good understanding of potential technical challenges and meeting the regulatory requirements and ICH’s quality and efficacy guidelines. 
• Collaborate with CMC functional areas to ensure successful execution of various CMC projects, and delivery of results on time and within budget.
• Chart the course, track progress against goals and outline key strategic events for project. Manage project scope definitions and changes, and budgets. 
• Serve as the center of solution. Address any challenges and issues that arise.  Make hard decisions. 
• Engage efficiently with key stakeholders to ensure transparency on program status and alignment on program plans, goals, resource requirements and timelines.
• Build a solid communication with client to ensure alignment between Biologics and clients. 
• Provide leadership in development and manufacturing alliance management, product development and manufacturing strategy
• Assist in recruiting, training and retaining a high performance CMC team to ensure best quality services and leadership in CMC management functions worldwide.
• Support BD efforts and proposal writing team to enhance current service offering and develop new clients. 
• Develop and manage operational budgets and supervise teams to ensure IP and EHS compliance. 

Requirements

Required Qualifications:

• Advanced degree (PhD or MS) in Bio/Chemistry, Bio/Chemical Engineering, Life Science or related major with 8+ years of applicable work experience.
• Good knowledge in CMC strategy, risk and resource management, regulatory requirements and ICH guidelines.
• Strategic view and leadership abilities as well as hands on problem solving skills. Experience in managing projects is required.
• Excitement about the vision and mission of Biologics. 

 
Preferred (but not required) Qualifications:
 

• Experience in two or more functional areas in Project Management, Cell Line Development, Cell Culture, Purification, Analytical, Formulation, Manufacturing, Manufacturing Support, QC or QA in the biologics industry.
• Experience with staff management and/or CMC team management.
• Ability to effectively work across all levels, functions, sites and companies.  Excellent verbal and written communication skills in both English and Chinese.
• Experience in writing regulatory documents and submissions and ability to work on multiple CMC projects at a time.

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