Sr Director / Director CMC Lead

WuXi XDC; Massachusetts; On-site; USD 130,000 - 180,000; Full time

Job summary

WuXi XDC is seeking a CMC Lead to drive project progression from proposal through completion by coordinating with clients, technical teams, and business development. The role includes visiting clients and promoting WuXi XDC’s services at conferences or trade shows.

The position offers remote work from home in US east regions (preferred PA, NJ, MA) and requires extensive CMC/process development experience in biopharma, with strong leadership and cross-functional collaboration skills.

Qualifications

• PhD in biochemistry, molecular biology, biochemical engineering, pharmaceutical science or related field.
• 5-10+ years in late stage and portfolio account management is a plus.
• Fluent in English and Mandarin Chinese.

Responsibilities

• Lead the orderly progression of projects from proposal to completion by coordinating with clients and technical teams.
• Promote WuXi XDC’s services at conferences/trade shows and visit existing or new clients.
• Coordinate cross-functional CMC activities for ADC/bioconjugate projects to meet timelines and budgets.
• Enhance service offerings and contribute to business development and alliance management.

Skills

Project management

Problem solving

Interpersonal skills

Cross-functional collaboration

English & Mandarin

Education

PhD in biochemistry/related

Tools

MS Office

Job description

WuXi XDC (stock code: 2268.HK), a leading Contract Research, Development and Manufacturing Organization (CRDMO) focused on the global antibody drug conjugates (ADCs) and broader bioconjugate market, is a pioneering CRDMO offering integrated, end-to-end services. Services are provided from proximately located, state-of-the-art laboratories and manufacturing facilities, allowing for a significant reduction in development timelines and costs. Headquarter in Shanghai, China, our over 1,000 skilled employees work across a global network to deliver expert-driven, high-quality and right-first-time project execution for our customers. By offering a single-source, open-access platform with the most comprehensive capabilities and technologies, WuXi XDC enables our biopharmaceutical partners to speed the development of innovative therapies for the benefit of patients worldwide.

About the job

Summary

The incumbent will lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical teams and business development team. The incumbent will also participate in business development activities such as visiting existing or new clients and promoting WuXi XDC’s services at conferences/trade shows.

This position will offer the candidate flexibility working remotely from home in US east,preferred areas like PA, NJ, MA.

Responsibilities

• Provide project and portfolio leadership supporting IND-enabling early and late stage bioproduct development CMC activities.
• Collaborate with CMC functional areas to ensure successful execution of various ADC or bioconjugate CMC projects, and delivery of results on time and within budget.
• Assist with development and manufacturing alliance management, product development and manufacturing strategy.
• Coordinate efforts and facilitate communication to ensure alignment between WuXi XDC and clients.
• Work with a high-performance team to ensure best quality services.
• Enhance current service offering and develop new clients.

Technical Skills /Knowledge

The candidate should possess strong and effective project management, problem solving and interpersonal skills, and have a proven track record of working cross-functionally, across a wide variety of technical, business, and operational areas.

Demonstrate good understanding of the pharmaceutical industry and large molecule drug development.

• The title of this CMC Lead position is flexible, ranging from Director to Sr. Director.
• A minimum of 10 years of relevant pharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing is required for Director title; a minimum of 5 years is required for Associate Director.
• Working knowledge and understanding of current regulations and industry trends for large molecule and ADC/bioconjugate product development, manufacture, and testing is a must.
• Working experience in ADC is strongly preferred.
• Experience with large pharma is preferred.
• Experience in a Contract Research Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred, but not required.

Customary Education and Experience

• PhD in biochemistry, molecular biology, biochemical engineering, pharmaceutical science or related discipline with 5-10+ working experience
• Experience in late stage and portfolio account management is a plus
• Strong Communication Skill
• Fluent in English and Mandarin Chinese.
• Must have working knowledge of MS Office products.
• Technical experience at large pharma or biotech companies.
• ADC/Biologics process/formulation/analytical development and/or manufacturing experience