Summary:
Opportunity for Director through the Executive level, depending upon experience. Leads the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team, and business development team. The incumbent will also participate in business development activities such as visiting existing or new clients and promoting WuXi Biologic’s services at conferences/trade shows.
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
- Serve as the center of solution and decision maker for technical issues
- 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:
- PhD in Biochemistry, Molecular Biology, Biochemical/Chemical Engineering or related discipline.
- Technical experience at large pharma or biotech companies.
- Depending upon the titles, a minimum of 8-20 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 the pharmaceutical industry and large molecule drug development.
- Working knowledge and understanding of current regulations and industry trends for large molecule and Antibody-Drug Conjugate (ADC) product development, manufacture, and testing
- Biologics manufacturing experience
- Ability to effectively work across all levels, functions, sites, and companies.
- Excellent verbal and written communication skills in both English and Chinese
- Candidate should possess strong and effective project management, problem solving and interpersonal skills and have a proven track record working cross-functionally across a wide variety of technical, business and operational areas.
- Experience in writing regulatory documents and submissions and the ability to work on multiple CMC projects at a time.
- Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred but not 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
