Company: Innovative Biopharmaceutical Company with huge investment
Job Title: Director, Senior Director or Executive Director of Process Development
Location: Washington, USA
Salary: $200,000 - 300,000 base salary (open to negotiation) + competitive bonus and stocks
Company Summary:
Our client is an innovative Oncology biopharmaceutical company developing next-generation treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as ADCs. With an a large investment this year, they are growing rapidly across all areas of the business. You will be part of something great from day one!
The Director/Senior Director will oversee the strategic and operational aspects of small molecule process development, ensuring that processes are optimized for both local and global needs.
Responsibilities:
- Lead and guide process development, characterization, validation studies, and technology transfer initiatives for small molecule therapeutics
- Work closely with manufacturing facilities and R&D centers in China to ensure alignment in process development and scale up between the U.S. and China.
- Identify and manage processes, and ensure successful technology transfer for GMP manufacturing
- Develop and implement analytical strategies to support antibody and ADC development, including phase-appropriate analytical development, characterization, and release strategies
- Compile and review CMC sections for IND, BLA, and other regulatory submissions
Qualifications
- Ph.D/M.S. in Chemistry or related field with at least 10+ years of laboratory experience
- Fluency in Mandarin both written and spoken is a must for this position
- Extensive experience in CMC strategy and small molecule drug development
Successful job hire will include a competitive salary, bonus and benefits
