Cambridge, Massachusetts, United States · On-site
$184k–$250k/yr
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, Purification Processes, Scale-up, Process Characterization
Cambridge, Massachusetts, United States · On-site
$122k–$177k/yr
Job title: Market Access - Pricing Data Analyst Location: Morristown, NJ About the Job Ready to push the limits of what’s possible? Join Sanofi in one of our corporate functions and you can play a vital part in the perfo…
Skills: SQL, Snowflake, Python, R, Power BI
Cambridge, Massachusetts, United States · On-site
$26/hr–$26/hr
Key details On-site Location: Cambridge, MA (Kendall Square) Part-time: 4 hours/day Mon-Fri either 8:45 AM-12:45 PM or 1:15-5:15 PM Temporary: 8 week fixed term September 24-November 20, 2026 Salary: $26.25/hour and $230…
Skills: DNA Assembly, Molecular Cloning, Mammalian Cell Culture, Mammalian Cell Transfection, BSL-1 Lab Safety
Cambridge, Massachusetts, United States · Remote OK
$111k–$138k/yr
Senior CRA- Phase I Oncology/NY/NJ ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation…
Skills: Clinical Trial Monitoring, Good Clinical Practice (GCP), Site Management, Data Integrity, Stakeholder Management
Cambridge, Massachusetts, United States · Hybrid
$99k–$183k/yr
Job Description Summary We are a team of passionate HR professionals, united by a shared purpose and a drive to succeed together. The US People & Organization (P&O) team is looking for a People Partner to join us in supp…
Skills: Business Acumen, Coaching, Data Analysis & Reporting, Empathy, Employee Lifecycle
Cambridge, Massachusetts, United States · On-site
Summary The Senior Clinical Trial Manager will lead the day-to-day activities in a clinical trial, and support the program strategy in a highly collaborative environment. The successful candidate will manage members of t…
Skills: Clinical Trial Management, CRO Oversight, Study Startup, Site Monitoring, GCP
Cambridge, Massachusetts, United States · Hybrid
$215k–$358k/yr
The Inflammation & Immunology Clinical Excellence & Innovation organization is seeking an experienced and enterprise-minded clinical development leader to serve as Senior Director, Clinical Excellence Group Lead. This hi…
Skills: Clinical Development, People Leadership, AI/ML Implementation, Clinical Trial Design, Change Management
Cambridge, Massachusetts, United States · Hybrid
$266k–$385k/yr
Job Title: NA Medical Head Transplant Location: Cambridge, MA, Morristown, NJ About the Job As NA Medical Head Transplant within our General Medicines team, you'll lead transformative medical strategies that directly imp…
Skills: Medical Strategy, Transplant Care, Budget Management, Stakeholder Collaboration, Clinical Research
Cambridge, Massachusetts, United States · On-site
Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowle…
Skills: Facilities Management, Preventative Maintenance, Vendor Management, CAPA, Root Cause Analysis
Cambridge, Massachusetts, United States · Remote OK
$111k–$138k/yr
Senior CRA Phase I Oncology-MA ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, in…
Skills: Clinical Trial Monitoring, Good Clinical Practice (GCP), Site Management, Data Integrity, Stakeholder Management
Cambridge, Massachusetts, United States · Remote OK
Senior CRA Phase I Oncology TN ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, in…
Skills: Clinical Trial Monitoring, Good Clinical Practice (GCP), Site Management, Data Integrity, Stakeholder Management
Cambridge, Massachusetts, United States · Hybrid
$139k–$232k/yr
Responsible for the scientific and clinical oversight of clinical trials in support of the development strategy for programs within the Inflammation & Immunology (I&I) portfolio. As an individual contributor, this role f…
Skills: Clinical Trial Design, Scientific Writing, Good Clinical Practice (GCP), Clinical Data Review, Regulatory Document Authoring
Cambridge, Massachusetts, United States · On-site
GENESIS HEALTHCARE SYSTEM In order to fill our Mission of serving our community by helping each person achieve optimal health and well-being by providing compassionate, exceptional, and affordable healthcare services, al…
Skills: Phlebotomy, Specimen Handling, Medical Terminology, Customer Service, Record Management
Cambridge, Massachusetts, United States · Remote OK
Senior CRA Phase I Oncology NC ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, in…
Skills: Clinical Trial Monitoring, Good Clinical Practice (GCP), Site Management, Data Integrity, Stakeholder Management
Cambridge, Massachusetts, United States · On-site
$21/hr–$32/hr
Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coa…
Skills: Cell culture media preparation, Aseptic technique, pH titration, GMP/GLP compliance, Good Documentation Practices (GDP)
Cambridge, Massachusetts, United States · Hybrid
$179k–$258k/yr
Job title: Biomarker and Precision Medicine Lead Location: Cambridge, MA/Morristown, NJ About the job As the Biomarker and Precision Medicine Lead, you’ll be developing and implementing translational medicine strategies …
Skills: Translational Medicine Strategy, Biomarker Validation, Immunology, Clinical Trial Design, Omics
Cambridge, Massachusetts, United States · Hybrid
$99k–$183k/yr
Band Level 4 Job Description Summary We are a team of passionate HR professionals, united by a shared purpose and a drive to succeed together. The US People & Organization (P&O) team is looking for a People Partner to jo…
Skills: Business Acumen, Coaching, Connecting The Dots, Data Analysis & Reporting, Empathy
Cambridge, Massachusetts, United States · Remote OK
$111k–$138k/yr
Senior CRA Phase I Oncology- NY/NJ ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation…
Skills: Clinical Trial Monitoring, Good Clinical Practice (GCP), Site Management, Data Integrity, Stakeholder Management
Cambridge, Massachusetts, United States · On-site
$100k–$170k/yr
Charles River Analytics, a GRVTY company, creates solutions and technology to tackle the world’s most challenging problems. Our team of technological entrepreneurs works together to push at the forefront of enhanced AI, …
Skills: Python, C++, Java, Rust, JavaScript
Cambridge, Massachusetts, United States · Remote OK
$165k–$223k/yr
Associate Director, Digital Quality Compliance This role serves as a business system owner and leader for Quality digital capabilities, with accountability for shaping and advancing enterprise Quality technologies, inclu…
Skills: SAP Quality Management, Veeva Vault Quality, LIMS, GxP Compliance, Data Integrity
Cambridge, Massachusetts, United States • On-site
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Lead a multi-site organization of scientists and engineers in the development and scale-up of drug substance cell culture and purification processes for late-stage biologics. Responsible for driving technical excellence, managing portfolio prioritization, and authoring global regulatory filings to enable commercial advancement.
Requires a Doctorate with 4 years, Master's with 8 years, or Bachelor's with 10 years of scientific process development experience, plus at least 4 years of people management. Preferred candidates hold a PhD in Biochemistry or Chemical Engineering with deep expertise in bioreactor or purification processes.
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.
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.
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.
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these 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
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)
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.
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.
.#WeareBiotech
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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