Amgen
Senior Scientist, Drug Product Technologies
US - California - Thousand Oaks · Senior
Sponsorship not specifiedDetected 67 days ago
Machine LearningDeep LearningData AnalysisData ScienceLLMsStatisticsProject ManagementRoboticsGMPFDA RegulatoryResearchLeadershipCommunicationPublic Speaking
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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
- Plan, design, execute, and document laboratory studies related to formulation, aseptic processing, visual inspection and fill/finish process development in support of product commercialization and life cycle management
- Leverage advanced AI technologies, including generative AI, large language models (LLMs), and in silico modeling, to drive innovation and accelerate research, development, and testing processes
- Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements.
- Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
- Deliver progress reports and presentations to ensure management awareness and engagement of the current status, advancement, and future program functional needs.
- Conducts risk assessment for inspection operations and propose / implement appropriate CAPA.
- Identifies and implements operational opportunities for current and new inspection operations.
- may include leading cross-site teams to support the above activities, providing recommendations to management.
Requirements
- Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]
- Master's degree and 3 years of Scientific experience
- Bachelor's degree and 5 years of Scientific experience
- Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software.
Nice to have
- Advanced degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutics or related field or Statistics degree with experience in pharmaceutical development and manufacturing.
- Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion and influencing decisions
- Excellent oral and written communications skills
- Award-winning time-off plans
- Experience in cGMP manufacturing environment, knowledge of cGMPs and other worldwide regulatory requirements, and experience in regulatory inspections.
- What you can expect of us
Compensation
- 126,066.05USD -170,559.95 USD
Company info
- Career Category Operations 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.
- We are seeking a Senior Scientist for our Drug Product Technologies Group in Thousand Oaks, CA.
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.