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WuXi XDC · 14 hours ago

Director/Senior Director，CMC lead

Boston, MA

Full-time

Hybrid

Lead/Staff, Director/Executive

5+ years exp

WuXi XDC is a leading Contract Research, Development and Manufacturing Organization (CRDMO) focused on the global antibody drug conjugates market. The role involves leading project progression, collaborating with technical teams, and engaging in business development activities to promote the company's services.

BiopharmaBiotechnologyManufacturing

Hiring Manager

Jessica Jin

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

Qualification

CMC Process DevelopmentGMP ManufacturingProject ManagementLarge Molecule Drug DevelopmentADC/Bioconjugate ExperienceRegulatory KnowledgeMS Office ProficiencyTechnical ExperienceFluent in EnglishFluent in MandarinInterpersonal SkillsProblem Solving

Required

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

Depending upon the title, minimal 5-20 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

MS/PhD in biochemistry, molecular biology, biochemical engineering, pharmaceutical science or related discipline

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