BioSpace
Process Development Senior Scientist
BioSpace, Thousand Oaks, California, United States, 91362
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 everything we do.
Since 1980, we have helped pioneer the world of biotech in our fight against the world’s toughest diseases. With a focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. 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 they lay within, you’ll thrive as part of the Amgen team.
Process Development Senior Scientist What You Will Do Amgen’s Commercial Attribute Sciences group in Thousand Oaks, California is seeking a Principal Scientist. The successful candidate will join our effort to deliver innovative human therapeutics worldwide by supporting Amgen’s marketed biologic products. You will provide analytical leadership of large‑molecule commercial programs and patient‑impact expansion/lifecycle management activities, partner closely with Quality, and represent Attribute Sciences on global cross‑functional teams including Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC, and Supply Chain.
Key Responsibilities
Lead analytical method lifecycle management activities including remediation, improvements, and support for method and validation transfers.
Contribute to global regulatory filings by authoring analytical CMC sections and responding to regulatory questions.
Provide independent authorship and review of technical reports, variations, and responses to analytical questions from health authorities.
Serve as analytical method subject‑matter expert during method‑related investigations (OOS/OOT and unexpected result root‑cause determinations).
Collaborate with cross‑functional teams across multiple geographic locations.
Establish timelines, outcomes, and communication for cross‑functional initiatives.
Prepare clear written and verbal communications for customers and senior leadership.
Implement innovative and fit‑for‑purpose analytical methods for release testing, stability testing, product characterization, investigations, and regulatory submissions.
Stay current in analytical development, including literature and technology development.
Lead post‑approval CMC LCM projects, managing testing activities for process characterization, PPQ, and analytical comparability studies, and provide oversight for regulatory submissions.
Basic Qualifications
Doctorate (PhD, PharmD, or equivalent) with or without post‑doctoral experience.
Master’s degree with 3 years of relevant experience.
Bachelor’s degree with 5 years of relevant experience.
Preferred Qualifications
Advanced degree in Bioanalytical Chemistry, Analytical Chemistry, Biochemistry, or Chemical Engineering.
3+ years in pharmaceutical/biotech process development and analytical method development.
Deep understanding of product quality attributes and control strategies throughout the product lifecycle.
Knowledge of analytical technologies such as chromatography, CE, general assays, gels, bioassays, and immunoassays for diverse modalities.
Experience leading analytical projects and managing commercial production methods.
Solid understanding of GMP requirements, USP monographs, and ICH guidance on method transfer and validation.
Experience with regulatory filings and commercial quality systems.
Strong communication skills and ability to provide cross‑functional leadership.
Knowledge of QbD and PAT as applied to pharmaceutical development.
Strong analytical write‑up skills and attention to detail.
Self‑starter with strong decision‑making and multitasking abilities.
Amgen is an Equal Opportunity Employer. We consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will provide reasonable accommodation to individuals with disabilities.
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Since 1980, we have helped pioneer the world of biotech in our fight against the world’s toughest diseases. With a focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. 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 they lay within, you’ll thrive as part of the Amgen team.
Process Development Senior Scientist What You Will Do Amgen’s Commercial Attribute Sciences group in Thousand Oaks, California is seeking a Principal Scientist. The successful candidate will join our effort to deliver innovative human therapeutics worldwide by supporting Amgen’s marketed biologic products. You will provide analytical leadership of large‑molecule commercial programs and patient‑impact expansion/lifecycle management activities, partner closely with Quality, and represent Attribute Sciences on global cross‑functional teams including Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC, and Supply Chain.
Key Responsibilities
Lead analytical method lifecycle management activities including remediation, improvements, and support for method and validation transfers.
Contribute to global regulatory filings by authoring analytical CMC sections and responding to regulatory questions.
Provide independent authorship and review of technical reports, variations, and responses to analytical questions from health authorities.
Serve as analytical method subject‑matter expert during method‑related investigations (OOS/OOT and unexpected result root‑cause determinations).
Collaborate with cross‑functional teams across multiple geographic locations.
Establish timelines, outcomes, and communication for cross‑functional initiatives.
Prepare clear written and verbal communications for customers and senior leadership.
Implement innovative and fit‑for‑purpose analytical methods for release testing, stability testing, product characterization, investigations, and regulatory submissions.
Stay current in analytical development, including literature and technology development.
Lead post‑approval CMC LCM projects, managing testing activities for process characterization, PPQ, and analytical comparability studies, and provide oversight for regulatory submissions.
Basic Qualifications
Doctorate (PhD, PharmD, or equivalent) with or without post‑doctoral experience.
Master’s degree with 3 years of relevant experience.
Bachelor’s degree with 5 years of relevant experience.
Preferred Qualifications
Advanced degree in Bioanalytical Chemistry, Analytical Chemistry, Biochemistry, or Chemical Engineering.
3+ years in pharmaceutical/biotech process development and analytical method development.
Deep understanding of product quality attributes and control strategies throughout the product lifecycle.
Knowledge of analytical technologies such as chromatography, CE, general assays, gels, bioassays, and immunoassays for diverse modalities.
Experience leading analytical projects and managing commercial production methods.
Solid understanding of GMP requirements, USP monographs, and ICH guidance on method transfer and validation.
Experience with regulatory filings and commercial quality systems.
Strong communication skills and ability to provide cross‑functional leadership.
Knowledge of QbD and PAT as applied to pharmaceutical development.
Strong analytical write‑up skills and attention to detail.
Self‑starter with strong decision‑making and multitasking abilities.
Amgen is an Equal Opportunity Employer. We consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will provide reasonable accommodation to individuals with disabilities.
#J-18808-Ljbffr