Senior Director - Head of Process Engineering (Synthetic Drug Substance Process Development)

Role: Senior Director and Head of Process Engineering within Amgen's Synthetic Drug Substance Process Development, leading a global team to develop and characterize small molecule and hybrid drug manufacturing processes for clinical and commercial use. Responsibilities: oversee process development, tech transfer, lifecycle management, and regulatory filings (IND/MAA); drive innovation and continuous improvement; ensure compliance with GxP standards; manage talent and cross-functional collaborations; represent the organization in scientific and regulatory forums. Requirements: PhD in Chemical Engineering or related field with 10+ years of process development experience, including management of large teams (>20 staff), expertise in small molecules, peptides, oligonucleotides, or bioconjugates; profound knowledge of cGMP operations, scale-up, validation, and regulatory submissions; strong leadership, strategic thinking, and external engagement skills. HighValue: small molecule and hybrid process development, cGMP, IND/MAA filings, technology transfer, lifecycle management, and global regulatory compliance. WorkSetup: on-site in Cambridge, MA or Thousand Oaks, CA; travel approximately 10-20% domestically and internationally.