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

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

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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

What you will do

Lets do this. Lets change the world. Would you like to lead a highly motivated team of process development experts and professionals to positively impact patients lives? Amgen is seeking a Senior Director to serve as our Head of Process Engineering within the Drug Substance Technologies Synthetics (DSTS) organization. In this role, the Senior Director will be a member of the DSTS Leadership Team and be accountable to drive technical and strategic solutions for the development, characterization, technology transfer, and lifecycle management of synthetic and hybrid drug substance manufacturing processes for our early- and late-phase clinical and commercial portfolios. In this on-site role located in either Cambridge, MA or Thousand Oaks, CA you will lead and develop a global, multisite organization of 30+ scientists and engineers, provide strategic oversite to ensure program success, and foster a culture of safety, quality, compliance, and technical excellence. In addition, you will represent the DSTS organization in our cross functional collaborations to ensure the successful implementation and performance of our clinical/commercial drugs substance manufacturing processes.

Key Responsibilities

• Lead a global organization with accountability for the capability of our small molecule/hybrid process engineering team, talent development, succession planning, performance management, and fostering a culture of innovation, collaboration, and operational excellence.
• Provide strategic oversight for the advancement of our synthetic & hybrid portfolio from early-phase clinical through commercial advancement and lifecycle management.
• Establish and implement improved engineering business and technology platforms from early-phase through commercial process development, process characterization, lifecycle management, and technology transfer.
• Strengthen the technical capabilities and innovative practices across the engineering organization.
• Author and review global regulatory filings (IND/INDa/MAA) and responses to regulatory agency questions.
• Foster a culture of safety, quality, and compliance while ensuring adherence to standard operating procedures.
• Recruit, develop, and retain a high-performing and diverse team.
• Manage portfolio prioritization, resource allocation, and budget.
• Partner with manufacturing and external network collaborators to enable successful process technology transfer, validation and clinical/commercial supply.
• Engage directly with the leadership and technical teams of our external partners and contract development & manufacturing organization (CDMOs).
• Drive ideation, development, and deployment of innovative and differentiating technologies that decrease development time and create more robustness and cost-effective processes.
• Identify process improvement opportunities to increase robustness and reduce cost over the lifecycle of commercial drug substance processes.
• Contribute to Amgens scientific eminence through publications, patents, and participation in external conferences and forums.
• Serve as a member of the Drug Substance Technology Synthetics Leadership Team and contribute to business, organizational, and changemanagement strategies.

Travel Requirements

May require approximately 10-20% travel (domestic and international).

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

Basic Qualifications

• Doctorate degree and 5 years of scientific process development experience, OR
• Masters degree and 9 years of scientific process development experience, OR
• Bachelors degree and 11 years of scientific process development experience, AND
• In addition to meeting at least one of the above requirements, you must have at least 5 years of experience directly managing people and/or organizational leadership experience leading teams, projects, or programs. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications

• PhD in Chemical Engineering or related discipline.
• 10+ years of experience in synthetic/hybrid pharmaceutical process development.
• Minimum of 5 years of experience directly managing people and managing an organization of >20 staff members.
• Subject matter expert in small molecule, peptide, oligonucleotide, and/or bioconjugate process development within the pharmaceutical industry.
• Expertise in cGMP operations, technology transfer, scale-up, and commercialization of active pharmaceutical ingredients.
• Experience managing technology transfer and manufacturing at contract manufacturing organizations (CMOs).
• Experience with quality risk management processes.
• Working knowledge of pertinent regulatory and ICH guidance.
• Experience with drafting regulatory filings (IND, MAA), annual product reviews (APR), briefing documents, and responses to regulatory questions.
• Fluency in synthetic and hybrid drug substance