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Process Development Director

2 months ago

Reston, Virginia, United States Discover International Full time
Director, Process Development/CMC

We're partnering with a leading oncology biotech to add a key member to our CMC team. This role involves close collaboration with our manufacturing facility and R&D center, as well as engaging with global partners in drug co-development.

The Director will oversee the strategic and operational aspects of ADC process development, ensuring that processes are optimized for both local and global needs.

Key Responsibilities:
  • Lead the development of ADC processes, ensuring compliance with regulatory requirements and industry standards.
  • Collaborate with cross-functional teams to design, develop, and optimize ADC manufacturing processes.
  • Develop and implement process control strategies to ensure consistency and quality.
  • Provide technical guidance and support to the CMC team.
  • Stay up-to-date with industry trends and advancements in ADC process development.
Requirements:
  • Ph.D. in chemistry, pharmaceutical sciences, or a related field with at least 10+ years of laboratory experience in an industrial setting.
  • M.S. in a relevant field with at least 12+ years of laboratory experience in an industrial setting.
  • Extensive experience in CMC strategy and antibody or ADC drug development.
  • Deep understanding of the design, development, optimization, and tech transfer of antibody or ADC manufacturing processes.
  • Proficiency in reading and writing Mandarin Chinese is required.