Join Amgenâs Mission of Serving Patients
At Amgen, if you feel like youâre part of something bigger, itâs because you are. Our shared missionâto serve patients living with serious illnessesâdrives all that we do.
Since 1980, weâve helped pioneer the world of biotech in our fight against the worldâs toughest diseases. With our focus on four therapeutic areas âOncology, Inflammation, General Medicine, and Rare Diseaseâ 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, youâll 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, youâll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Director, Bioprocess / Process Development â Pivotal Drug Substance
What you will do
In this leadership role, you will be responsible for the development, characterization, scaleâup, 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 multiâsite 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 proteinâbased modalities, and play a key role in advancing lateâstage and commercial drug substance strategies across Amgenâs manufacturing network.
Key Responsibilities
Lead a highâimpact, multiâfunctional 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 Amgenâs 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 changeâmanagement 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
Masterâs degree and 8 years of scientific process development experience, OR
Bachelorâs 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 lateâstage biologics development including process design, characterization, validation (PPQ), and regulatory interactions
Proven ability to provide scientific and engineering leadership on complex crossâfunctional programs
Demonstrated experience in statistical data analysis, technical decisionâmaking, and seniorâlevel 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, weâll 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
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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.
.Salary Range
184,494.20USD -249,609.80Â USDamgen