Senior Director, Mid-Atlantic CMC

Job Title – Senior Director, CMC Work Location – United States (Remote) 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, meeting 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 a 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 titles). Demonstrates a strong understanding of the pharmaceutical industry and large molecule drug development. Working knowledge of current regulations and industry trends for large molecule and Antibody‑Drug Conjugate (ADC) product development, manufacture, and testing. Biologics manufacturing experience. Ability to work effectively across all levels, functions, sites, and companies. Excellent verbal and written communication skills in both English and Chinese. Strong project‑management, problem‑solving, and interpersonal skills with a proven track record of cross‑functional collaboration across technical, business, and operational areas. Experience writing regulatory documents and submissions; ability to manage multiple CMC projects simultaneously. Experience with CRO or CMO environments 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. The pay range for this job opportunity is $160,000 – $274,000. The job description does not intend to list all the duties and responsibilities assigned to this position; an employee holding this position would be required to perform other job‑related duties/responsibilities based on their expertise and the company’s business needs. #J-18808-Ljbffr WuXi Biologics