Senior Director, Process Engineering - Synthetic Drug Substance

BioSpace; Thousand Oaks (CA); On-site; USD 220,000 - 380,000; Full time

Job summary

Amgen seeks a Senior Director to lead Process Engineering within the Drug Substance Technologies Synthetics division. This on-site role is located in Cambridge, MA or Thousand Oaks, CA and will oversee 30+ scientists and engineers, driving development, characterization, tech transfer, and lifecycle management of synthetic and hybrid drug substances.

You will guide strategy, talent development, and collaboration with CDMOs and manufacturing to ensure safe, compliant, scalable processes that

Qualifications

• Doctorate or equivalent with leadership in science-based process development.
• Experience directing teams and programs in pharmaceutical process engineering.
• Strong regulatory filing and technology transfer exposure.

Responsibilities

• Lead a global organization with accountability for process engineering capability and culture.
• Provide strategic oversight for synthetic & hybrid portfolios from early phase to commercial.
• Establish platforms for process development, characterization, lifecycle management, and tech transfer.
• Strengthen technical capabilities and innovative practices across the engineering organization.
• Author and review global regulatory filings (IND/INDa/MAA) and responses to authorities.
• Foster safety, quality, and compliance while ensuring SOP adherence.
• Recruit, develop, and retain a high-performing, diverse team.
• Manage portfolio prioritization, resources, and budget allocation.
• Partner with manufacturing and CDMOs for tech transfer and supply.
• Engage with external partner leadership and technical teams.
• Drive ideation and deployment of innovative technologies to reduce development time.
• Identify process improvements to increase robustness and reduce lifecycle costs.
• Contribute to Amgen's scientific eminence via publications and patents.
• Serve on the DSTS Leadership Team and contribute to strategy and change management.

Skills

Leadership

People management

Strategic planning

Regulatory knowledge

Cross-functional collaboration

Process engineering

Project management

Team development

Education

Doctorate degree in Chemical Engineering or related field

Masters degree in a related field

Bachelors degree in a related field

Job description

Amgen seeks a Senior Director to lead Process Engineering within the Drug Substance Technologies Synthetics division. This on-site role is located in Cambridge, MA or Thousand Oaks, CA and will oversee 30+ scientists and engineers, driving development, characterization, tech transfer, and lifecycle management of synthetic and hybrid drug substances.

You will guide strategy, talent development, and collaboration with CDMOs and manufacturing to ensure safe, compliant, scalable processes that