Amgen · 1 month ago
Process Development Senior Scientist
Thousand Oaks, CA
Full-time
Hybrid
Mid, Senior Level
3+ years expAmgen is a leading biotechnology company focused on serving patients with serious illnesses. The Process Development Senior Scientist will support the analytical leadership of large molecule commercial programs, engage in regulatory filings, and collaborate with various functional areas to ensure the success of Amgen’s marketed biologic products.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Lead analytical method lifecycle management activities including method remediation, improvements, and support method and validation and transfers
Contribute to global regulatory filings by authoring analytical CMC sections and RTQs ensuring success of commercial approval and launch
Independent authorship and review of technical reports, variations and responses to analytical questions from health authorities
Provide analytical method subject matter expert leadership support of product quality and method-related investigations including OOS/OOT and unexpected result root cause determinations
Interface and collaborate with other functional areas in matrix environment, including team across various geographic locations in different time zones
Duties may include establishing timelines, achievements, methodological approaches, expected results, necessary resources and communication to global cross-functional team members
Prepare clear written and verbal communications to key customers and senior leadership
Implementing innovative and fit-for-purpose analytical methods for: release testing, stability testing, product characterization/optimization, investigations, and regulatory submissions, which may include laboratory activities
Keeping current in the analytical development field including literature and technology development for cutting edge and regulatory driven activities
Provide analytical leadership for post-approval CMC LCM projects, facilitate and manage testing activities in support of process characterization, PPQ, and analytical comparability studies, develop derisk strategies, provide oversight to analytical results for regulatory submissions
Qualification
Required
Doctorate degree PhD OR PharmD [and relevant post-doc where applicable]
Master's degree and 3 years of relevant experience
Bachelor's degree and 5 years of relevant experience
Preferred
Advanced degree in Bioanalytical Chemistry, Analytical Chemistry, Biochemistry, Biochemical or Chemical Engineering
3+ years pharmaceutical/biotech experience in process development and analytical method development
Deep understanding of product quality attributes and control strategies, quality attribute assessments, and Quality Target Product Profile throughout the lifecycle of a product
Commanding knowledge of analytical methods/technologies such as Chromatography, CE, General Assays (e.g. pH, Osmolality, Karl Fisher titration, etc.), Gels, Bioassays and Immunoassays used to test diverse modalities including monoclonal and bispecific antibodies, bispecific T-cell engagers (“BiTEs”), synthetic peptides and biosimilar products
Analytical project leadership experience
Strong leadership skills and ability independently lead
Solid understanding of GMP requirements and familiarity with USP monographs and chapters, as well ICH guidance documents related to analytical method transfer and validation
Experience with developing, implementing and commercializing methods for in-process testing, process characterization, release and stability testing
Strong understanding of regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements
Strong understanding of drug substance and drug product manufacturing processes
Experience with regulatory filings and commercial quality systems
Experience working closely with process engineers and quality control laboratories to generate and interpret analytical data to provide enhanced understanding and guidance around process understanding and control
Experience with QbD and PAT, as applied to pharmaceutical development
Experience managing and transferring commercial production and test methods
Strong communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
A diplomatic approach – trusting and respectful interaction with global colleagues from a broad diversity of backgrounds – emphasis on listening
Excellent technical writing skills and attention to detail in authoring technical reports and regulatory filing documents
A self-starter and teammate with strong decision-making skills
Ability to multitask, clearly plan and effectively follow through on complex deliverables
Benefits
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
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, including remote and hybrid work arrangements, where possible
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
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