CMC Director

Das ist der Job

Chines is a plus. • Strategic view and leadership abilities as well as hands on problem solving skills.

Darum lohnt es sich

Summary: Lead the oversight of projects from the proposal stage through project completion by interacting with the client, technical team, and business development team.

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 ICH’s 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 services, IP, 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 of 8-15 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.

The position will also participate in business development activities such as visiting clients and promoting WuXi Biologic’s services at conferences/trade shows. Ability to plan & prioritize and handle multiple CMC projects at a time. • Excellent verbal and written communication skills in English.

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