Senior Director, Process Eng. — Synthetic Drug Substance

Amgen SA; Thousand Oaks (CA); On-site; USD 260,000 - 520,000; Full time

Job summary

Amgen is seeking a Senior Director to serve as Head of Process Engineering within Drug Substance Technologies – Synthetics (DSTS), based on-site in Thousand Oaks, CA or Cambridge, MA. You will lead a 30+ person team, oversee development, characterization, tech transfer, and lifecycle management of synthetic drug substances for early and late-phase programs.

Responsibilities include strategic oversight, collaboration with CDMOs, and driving innovative, cost-effective manufacturing solutions while

Qualifications

• PhD in Chemical Engineering or related discipline.
• 10+ years of synthetic/hybrid pharmaceutical process development.
• 5+ years of direct people leadership managing teams (>20 staff).
• Experience drafting regulatory filings (IND, MAA) and responding to regulatory questions.
• Experience with cGMP operations, technology transfer, scale-up, and commercialization of drug substances.

Responsibilities

• Lead a global organization with accountability for small molecule/hybrid process engineering capability, talent development, and performance management.
• Provide strategic oversight for synthetic & hybrid portfolio from early-phase to commercial lifecycle management.
• Establish and implement engineering platforms from early-phase through tech transfer and lifecycle management.
• Strengthen technical capabilities and innovative practices across the engineering organization.
• Author and review global regulatory filings (IND/INDa/MAA) and responses to questions.
• Foster safety, quality, and compliance while ensuring SOP adherence.
• Recruit, develop, and retain a high-performing, diverse team; manage portfolio prioritization and budget.
• Collaborate with manufacturing and external partners for technology transfer and supply.

Job description

Amgen is seeking a Senior Director to serve as Head of Process Engineering within Drug Substance Technologies – Synthetics (DSTS), based on-site in Thousand Oaks, CA or Cambridge, MA. You will lead a 30+ person team, oversee development, characterization, tech transfer, and lifecycle management of synthetic drug substances for early and late-phase programs.

Responsibilities include strategic oversight, collaboration with CDMOs, and driving innovative, cost-effective manufacturing solutions while