Senior Director, Mid Atlantic CMC

About the role

Opportunity for Senior 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 Biologics’s services at conferences and 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.
• Write regulatory documents and submissions and work on multiple CMC projects at a time.

Requirements

• PhD in Biochemistry, Molecular Biology, Biochemical/Chemical Engineering, or related discipline.
• Technical experience at large pharma or biotech companies.
• 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, depending on title.
• 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.
• Strong and effective project management, problem-solving, and interpersonal skills with a proven track record working cross-functionally across a wide variety of technical, business, and operational areas.
• Experience in a Contract Research Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred but not required.
• Must be a self-starter, self-motivated, and highly flexible in this home-based position with about 10%-15% travel.
• Must be organized and detail-oriented.

Pay

The pay range for this job opportunity is $161,300 - $274,200.