Director, Bioprocess / Process Development – Pivotal Drug Substance
Cambridge, Massachusetts, United States · On-site
$184k–$250k/yr
Senior+$29B raised
Career CategoryProcess DevelopmentJob Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living wit…
Skills: Bioprocess development, Cell culture, Downstream purification, Process characterization, Scale-up
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Cambridge, Massachusetts, United States · Remote OK
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Director / Executive Director, Modeling & Simulation (Dual Level Posting)
Cambridge, Massachusetts, United States · Hybrid
$176k–$419k/yr
Senior+$4.5B raised
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Director / Executive Director, Modeling & Simulation (Dual Level Posting)
Cambridge, Massachusetts, United States · Hybrid
$176k–$419k/yr
Senior+$4.5B raised
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$184k–$250k/yr
Full-time
bachelor degree, postgraduate degree
Health insurance, Dental coverage, Vision coverage, Retirement and savings plan, Life insurance, Disability insurance
Posted 37d ago
~40 hrs/week
Responsibilities
The Director will lead a multi-site organization to develop, characterize, and scale up drug substance processes for late-stage and commercial programs. They are responsible for driving technical excellence, managing a diverse team, and ensuring successful regulatory filings and commercialization strategies.
Requirements
Candidates must hold a Doctorate with 4 years of experience, a Master's with 8 years, or a Bachelor's with 10 years of scientific process development experience. Additionally, at least 4 years of direct people management or leadership experience is required.
Full job description
Career Category
Process Development
Job Description
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
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.
Apply now and make a lasting impact with the Amgen team.
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 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.
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes.
For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads.
🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines
🔗Global Privacy Statement Directory: www.amgen.com/dp
Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
Offices: One Amgen Center Drive, Thousand Oaks, CA 91320, US · 1120 Veterans Blvd, South San Francisco, CA 94080, US · 34 Commerce Way, Woburn, MA 01801, US · Avenida Calle 100 7-81, Bogota, Bogota, D.C. 110221, CO · Minervum 7061, Breda, North Brabant 4817 ZK, NL
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