Senior Director, Mid-Atlantic CMC

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.
• Able 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 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 home-based position with about 10%-15% travel.
• Must be organized and detail-oriented.

Pay

The pay range for this job opportunity ranges from $160,000 - $274,000.