Director, Bioprocess / Process Development Pivotal Drug Substance

BioSpace; Cambridge (MA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Total Rewards Plan

Comprehensive benefits

Discretionary annual bonus

Stock-based incentives

Flexible work models

Job summary

Amgen seeks a Director of Bioprocess / Process Development to lead drug substance development, characterization, scale-up, and support for Phase II/III to commercial programs. The role oversees 30+ scientists across Cambridge, MA and Thousand Oaks, CA, driving process excellence, safety, and innovation.

You will guide portfolios spanning monoclonal antibodies, bispecifics, and other biologics, steering technology deployment and regulatory engagement while shaping the science and strategic

Qualifications

• Doctorate or equivalent with substantial process development experience
• Experience leading large, multi-site bioprocess teams
• Strong background in cell culture and downstream purification
• Proven track record with regulatory interactions (IND/MA)

Responsibilities

• Lead multisite drug substance organization across cell culture and purification disciplines
• Recruit, develop, and retain diverse team; prioritize portfolios and resources
• Advance commercial process development, characterization, lifecycle management, and control strategies
• Partner with engineering, manufacturing, and external collaborators for process transfer and commercialization
• Author and review regulatory filings and respond to agency questions
• Drive development of innovative bioprocess technologies
• Contribute to scientific leadership through publications and conferences
• Participate in leadership discussions on business strategy and change management

Skills

Leadership

Bioprocess

Cell culture

Purification

Regulatory filings

Team management

Education

PhD in Biochemistry/Biochemical Engineering/Chemical Engineering

MS in Biochemical Engineering

BS in Biotechnology

Tools

Bioprocessing equipment

Process development software

Job description

Join Amgens Mission of Serving Patients

Director, Bioprocess / Process Development Pivotal Drug Substance

What You Will Do

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 Amgen’s 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 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 changemanagement 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
• Masters degree and 8 years of scientific process development experience, OR
• Bachelors 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 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)

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 my competitive benefits to our collaborative culture, well 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.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer

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.