Director, Bioprocess / Process Development – Pivotal Drug Substance

Director, Bioprocess / Process Development – Pivotal Drug Substance

What you will do

In this leadership role, you will be responsible for the development, characterization, scale‑up, 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 multi‑site 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 protein‑based modalities, and play a key role in advancing late‑stage and commercial drug substance strategies across Amgen’s manufacturing network.

Key Responsibilities

• Lead a high‑impact, multi‑functional 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 Amgen’s 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 change‑management strategies.

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 4 years of scientific process development experience, OR
• Master’s degree and 8 years of scientific process development experience, OR
• Bachelor’s degree and 10 years of scientific process development experience And

In addition to meeting at least one of the above requirements, you must have at least 4 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 late‑stage biologics development including process design, characterization, validation (PPQ), and regulatory interactions
• Proven ability to provide scientific and engineering leadership on complex cross‑functional programs
• Demonstrated experience in statistical data analysis, technical decision‑making, and senior‑level communication
• Track record of developing talent through coaching, mentoring, and feedback
• Active engagement in the scientific community (publications, patents, industry forums)

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

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.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A 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. Refer to the Work Location Type in the job posting to see if this applies.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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