CMC Sr. Director / Director

WuXi XDC; San Francisco (CA); On-site; USD 250,000 - 390,000; Full time

Job summary

WuXi XDC, a leader in pharmaceutical development services in the Bay Area, seeks a Senior Director for CMC leadership. This role drives IND-enabling through late-stage development, coordinating with clients and internal scientific and business teams to ensure on-time, within-budget execution of ADC/bioconjugate projects.

Ideal candidates hold a PhD with 15+ years in CMC process development or GMP manufacturing, plus strong English and Mandarin proficiency, and a proven CRO/CMO background.

Qualifications

• PhD required with 15+ years in pharma/biotech CMC or GMP manufacturing.
• Fluent in English and Mandarin Chinese.
• ADC/bioconjugates experience is required.
• Experience with late-stage and commercial projects.
• Experience in CRO/CMO settings preferred.

Responsibilities

• Lead project and portfolio activities from proposal through completion with clients and internal teams.
• Collaborate with CMC functions to deliver ADC/bioconjugate CMC projects on time and within budget.
• Assist with development and manufacturing alliance management and strategy.
• Coordinate communication between WuXi XDC and clients.
• Lead a high-performance team to deliver high-quality services.
• Grow service offerings and acquire new clients.

Skills

Project management

Problem solving

Interpersonal skills

Cross-functional collaboration

Communication skills

Education

PhD in Biochemistry/Molecular biology/Biochemical engineering/Pharmaceutical science

Tools

MS Office

Job description

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 prefers candidates locate in the Bay Area or West Coast in general".

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 a Senior Director.
• Minimal 15 years of relevant pharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing is required.
• 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 or bioconjugates is required.
• Experience with late stage and commercial projects are required.
• 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 15+ experience.
• Fluent in English and Mandarin Chinese.
• Strong Communication Skill
• Experience in ADC is and late stage is a must
• Experience in portfolio account management is a plus
• 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