Assistant Director/Director, Process Chemistry

Piper Companies is currently seeking an Assistant Director/Director, Process Chemistry for a company that finds, develops, and delivers breakthrough medicines for genetic diseases. The Assistant Director/Director, Process Chemistry will be joining a growing CMC team to manage analytical development and quality control activities. This is a fully remote role that can sit anywhere in the US, with travel requirements up to 20%!

Responsibilities of the Assistant Director/Director, Process Chemistry:

• Oversee contract development and manufacturing organizations to Process Chemistry activities for drug substance
• Collaborate with the Analytical team within stability programs
• Work cross functionally with Process Chemistry other CMC team members and communicate regularly
• Support and author drug substance content for CMC Regulatory for US and Rest of World dossiers.
• Utilize QC knowledge to support quality assurance audits.
• Provide on-site technical support as needed for different manufacturing/scale-up/validation activities. Helping to troubleshoot any process issues with manufacturing/packaging.
  
  

Qualifications of the Assistant Director/Director, Process Chemistry:

• Degree (BS, MS, or Ph.D.) in Chemistry, Chemical Engineering or a related discipline
• 10+ years of small molecule pharmaceutical manufacturing/process chemistry experience
• Late stage process development experience
• Knowledge of GMP's, quality, and regulatory requirements
• Validation experience
• Proving experience authoring NDA's, and other regulatory documents
  
  

Compensation for the Assistant Director/Director, Process Chemistry:

• Salary Range: $190,000-$240,000
• Comprehensive Benefits: Generous benefits package with competitive PTO offering, and bonuses!
  
  

Keywords: Chemistry, Chemical Engineering, small molecule, pharmaceutical manufacturing, process chemistry, late stage, process development, GMP, quality, Director, AD, Assistant Director, quality, regulatory, genetic diseases, QC, pharma, CDMO, Contract Development Manufacturing Organization, CMC, drug substance