Senior Director, Bioprocess / Process Development Pivotal Drug Substance

About the Role

In this leadership role, you will be responsible for the development, characterization, scaleup, and support of drug substance cell culture and purification processes to enable commercial advancement of programs from Phase II/III through marketing applications. Located in Cambridge, MA and/or Thousand Oaks, CA, you will lead and develop a multisite organization of 30+ scientists and engineers while driving program success, safety culture, technical excellence, innovation, automation, and digital strategies. You will support a diverse portfolio of biologics, including monoclonal antibodies (mAbs), BiTEs, bispecifics, biosimilars, and other novel proteinbased modalities, and play a key role in advancing latestage and commercial drug substance strategies across Amgens manufacturing network.

Key Responsibilities

• Lead a highimpact, multifunctional drug substance organization integrating cell culture and purification disciplines across multiple sites.
• Recruit, develop, and retain a strong and diverse team; manage portfolio prioritization and organizational resourcing.
• Advance integrated drug substance processes through commercial process development, process characterization, lifecycle management, and control strategy development.
• Partner with engineering, manufacturing, and external network collaborators to enable successful process transfer and commercialization.
• Author and review global regulatory filings (IND/INDa/MA) and respond to regulatory agency questions.
• Drive ideation, development, and deployment of innovative and differentiating bioprocess technologies.
• Contribute to Amgens scientific and regulatory eminence through publications, patents, and participation in external conferences and forums.
• Serve as a member of the Drug Substance Technology extended leadership team and contribute to business, organizational, and changemanagement strategies.

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
• In addition to meeting at least one of the above requirements, you must have at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications

• PhD in Biochemistry, Biochemical Engineering, Chemical Engineering, or related discipline
• 10+ years of experience in biopharmaceutical process development
• Minimum of 4 years of experience directly managing people
• Deep expertise in either cell culture bioreactor processes OR downstream purification processes
• Strong understanding of latestage biologics development including process design, characterization, validation (PPQ), and regulatory interactions
• Proven ability to provide scientific and engineering leadership on complex crossfunctional programs
• Demonstrated experience in statistical data analysis, technical decisionmaking, and seniorlevel communication
• Track record of developing talent through coaching, mentoring, and feedback
• Active engagement in the scientific community (publications, patents, industry forums)

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.