Amgen
Director, Bioprocess / Process Development – Pivotal Drug Substance
US - Massachusetts - Cambridge · Director
Sponsorship not specifiedDetected 70 days ago
Data AnalysisCell CultureResearchLeadershipCommunicationMentoring
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odds of building a lasting career here
38Risky
Cap-exempt (no lottery)0
Sponsors this role85
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
Thin sponsorship signal and lottery-bound. A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.
Lottery odds assume a STEM candidate.
Personalize to your clock →Employer immigration record
from this employer's Department of Labor filings
Green-card filing pattern in this occupation
Context, not a finding about this posting: of this employer's 101 green-card filings in this occupation, 100% were for a worker who already held the job.
Green-card follow-through: 92%
Of 75 labor certifications old enough to have been used, 6 expired without the employer filing the next step. Median time from filing to decision: 486 days.100% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.
Files H-1B transfers
17 transfer filings in the last year, covering 17 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
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About the role
- Join Amgen's Mission of Serving Patients
- At Amgen, if you feel like you're part of something bigger, it's because you are.
- Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases.
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.
- Partner with engineering, manufacturing, and external network collaborators to enable successful process transfer and commercialization.
- Drive ideation, development, and deployment of innovative and differentiating bioprocess technologies.
- 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.
- 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.
- 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.
Requirements
- 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
- Your managerial experience may run concurrently with the required technical experience referenced above
Nice to have
- 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
- Active engagement in the scientific community (publications, patents, industry forums)
Compensation
- 184,494.20USD -249,609.80 USD
Company info
- 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.
- If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team.
- What we expect of you We are all different, yet we all use our unique contributions to serve patients.
- We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
Equal opportunity
- 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.
- Please contact us to request accommodation.
- 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.
Visa & Work Authorization
- Sponsorship for this role is not guaranteed.
This listing is sourced directly from Amgen's careers page and normalized into a canonical job model.