Senior Director, CMC

Job Title - Senior Director CMC 

Location- Remote 

WuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics’ achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies

Summary: 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 strategyLead 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 issuesCoordinate efforts and facilitate communication to ensure alignment between WuXi Biologics and clientsWork 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 manufacturingDemonstrates 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 testingBiologics manufacturing experienceAbility to effectively work across all levels, functions, sites, and companies.


• Excellent verbal and written communication skills in both English and ChineseCandidate 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.

Salary range for this posiion is $161,300 - $274,200

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.