Amgen Inc
Process Development Senior Scientist – Drug Product Technologies
US - California - Thousand Oaks · Senior
Sponsorship not specifiedDetected 1 day ago
Machine LearningData ScienceLLMsResearchMass SpectrometryAnimal StudiesLeadershipCollaborationMentoring
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16Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- 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.
Responsibilities
- Work effectively in a fast-paced, matrixed environment, collaborating across process development, research, analytical, regulatory, quality, manufacturing, and external partner teams to advance programs, influence development strategies, and communicate technical recommendations to scientific peers and leadership.
- Plan, lead, and execute formulation, stability, process development, and fill/finish studies for early-stage drug product programs across diverse biologic modalities.
- Develop and characterize liquid and lyophilized formulations for complex biologics, including ADCs, oligonucleotides, monoclonal antibodies, multispecifics, and other emerging modalities.
- Build process understanding across unit operations to support scalable drug product development.
- Author and review technical documents, formulation and process development reports, control-strategy inputs, risk assessments, IND/CTA regulatory sections, and technology transfer packages.
- The candidate will integrate formulation, analytical, stability, and process data to guide product design and development, including modality-specific considerations such as linker-payload attributes, stability- and process-relevant degradation pathways, ADC CQAs, oligonucleotide formulation and stability considerations, and phase-appropriate analytical strategies.
- This individual will apply scientific judgment, emerging technologies including AI/ML, and strong cross-functional collaboration to deliver high-quality, stable, and manufacturable drug products for clinical development in a fast-paced environment.
- Support internal and external technology transfer activities, including collaboration with CMOs/CDMOs, batch record review, process fit assessments, person-in-plant support, and troubleshooting during manufacturing campaigns.
Requirements
- Doctorate degree
- Master's degree and 2 years of Scientific experience
- Bachelor's degree and 4 years of Scientific experience
Nice to have
- PhD in Pharmaceutics, Biotechnology, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field with 3+ years of relevant industry experience.
- Proven experience in biologics drug product formulation development, stability assessment, process development, and/or fill/finish operations
- direct experience with ADCs, oligonucleotides such as siRNAs, or other complex biologic modalities is strongly preferred.
- Experience integrating formulation, stability, analytical, and process data to advance drug product candidates from discovery or preclinical development into clinical manufacturing.
- Familiarity with clinical-stage development, manufacturability, technology transfer, and risk-based decision-making.
- Skilled communicator with experience authoring technical reports and contributing to regulatory submissions, including INDs, CTAs, BLAs, or equivalent global filings.
- Award-winning time-off plans
- What you can expect from us
Compensation
- 126,066.05USD -170,559.95 USD
Benefits
- Apply machine learning, AI, automation, and data science approaches to predictive modeling, workflow acceleration, data integration, and decision-making.
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.
- 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.
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.
- Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
- 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.
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This listing is sourced directly from Amgen Inc's careers page and normalized into a canonical job model.