CMC Director (Europe Based)

Summary:

Lead the oversight of projects from the proposal stage through project completion by interacting with the client technical team and business development team. The position will also participate in business development activities such as visiting clients and promoting WuXi Biologics services at conferences/trade shows. This role will be remotely based in Europe.

Responsibilities:

• Provide technical and portfolio leadership to support IND and BLA enabling CMC activities.
• Collaborate with CMC functional areas to ensure the successful execution of various CMC projects and the delivery of results on time and within budget.
• Provide strategic thinking and technical guidance for the project teams in product development and manufacturing strategy
• Lead CMC projects with a good understanding of potential technical challenges and meeting the regulatory requirements and ICHs guidelines
• Coordinate efforts and facilitate communication to ensure alignment between WuXi Biologics and clients
• Work with a high-performance team to ensure the best quality servicesIP and EHS compliance.
• Support corporate business development to enhance the current service offering and develop new clients

Qualifications:

• Advanced degree (Ph.D. or MSc.) in Biochemistry Molecular Biology Biochemical/Chemical Engineering or related discipline.
• Depending upon the titles a minimum of8-15 years of relevant pharmaceutical or biotech industry experience in cell line development CMC process development analytical sciences and/or GMP manufacturing.
• Demonstrates good understanding of current regulations and industry trends for large molecules including but not limited to bispecific antibody and antibody drug conjugates.
• Ability to effectively work in a matrix organization across functions and sites. Ability to plan & prioritize and handle multiple CMC projects at a time.
• Excellent verbal and written communication skills in English. Chines is a plus.
• Strategic view and leadership abilities as well as hands on problem solving skills. Experience in project management is required.
• Must be a self-starter self-motivated and highly flexible in this homebased position with about 10%-15% travel. Must be organized and detail-oriented.

Opportunities:

• Broaden knowledge and experience in the field of biopharmaceutical industry from drug discovery development and commercialization
• Develop and enhance leadership skills in people and project management
• Strengthen interpersonal and communication skills
• Build up business acumen and network collaboration