BioSpace
Process Development Senior Scientist Analytical Development
BioSpace, Thousand Oaks, California, United States, 91362
Process Development Senior Scientist Analytical Development
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Process Development Senior Scientist Analytical Development
role at
BioSpace .
Amgen is committed to serving patients worldwide and values integrity, innovation, and collaboration. In this vital role you will support the Pivotal Attribute Sciences Department in Thousand Oaks, CA, contributing to late‑phase analytical development for drug substances and products.
The Scientist will work closely with a multidisciplinary team of analytical chemists, organic chemists, and formulation scientists to develop analytical tools that provide insight into key quality attributes for synthetic programs. You will contribute to analytic method development, validation, transfer, and GMP testing of late‑phase drug substances and products.
Key Responsibilities
Define analytical control strategies and implement methodologies for pivotal phase clinical programs.
Develop, optimize, and authorize analytical methods for synthetic molecule release testing and characterization.
Collaborate closely with drug substance and drug product process development colleagues to achieve project objectives.
Provide analytical data to support drug substance and drug product development, including purity analysis, chiral purity, and structure elucidation using mass spectrometry.
Manage activities at contract manufacturing and testing sites.
Lead method transfer to CMO or contract testing labs when required.
Review and approve protocols and reports from CMO and contract testing labs.
Support project team lead in authoring technical reports and Analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents.
May lead and develop a small group of scientists.
What We Expect Of You The analytical professional we seek is an emerging Scientist with the following qualifications.
Basic Qualifications
Bachelor’s degree and 5 years of scientific experience, or
Master’s degree and 3 years of scientific experience, or
Doctorate degree (PhD, PharmD, MD) and relevant post‑doctoral experience.
Preferred Qualifications
PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, or Chemical Engineering.
2+ years post‑PhD experience in the pharmaceutical or biotech industry in process development and drug substance/product analytical method development.
Strong understanding of small‑molecule analysis, structure elucidation, solid‑state characterization, and organic chemistry.
Proficiency in liquid chromatographic and mass spectroscopic analysis.
Experience with MS, NMR, UV, FTIR, and related physicochemical techniques.
Experience developing and implementing methods for in‑process, release, and stability testing.
Familiarity with USP monographs, ICH/FDA guidance on analytical method transfer, validation, impurities, and mutagenic impurities.
Solid understanding of GLP and GMP requirements and their application in a phase‑appropriate manner.
Experience with technical transfer for non‑GMP and GMP production and testing to external contract organizations.
Strong communication skills and ability to provide cross‑functional leadership and guidance to CMC and non‑clinical teams.
Excellent technical writing skills with attention to detail in authoring methods, specifications, technical reports, and regulatory filings.
What You Can Expect From Us Amgen offers a competitive compensation and benefits package, including a Total Rewards Plan, health and welfare plans, financial plans, flexible work models, and career development opportunities. In addition to the base salary, we provide annual bonuses, stock‑based incentives, and generous retirement contributions.
Equal Opportunity Statement 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. We provide reasonable accommodation for individuals with disabilities.
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Process Development Senior Scientist Analytical Development
role at
BioSpace .
Amgen is committed to serving patients worldwide and values integrity, innovation, and collaboration. In this vital role you will support the Pivotal Attribute Sciences Department in Thousand Oaks, CA, contributing to late‑phase analytical development for drug substances and products.
The Scientist will work closely with a multidisciplinary team of analytical chemists, organic chemists, and formulation scientists to develop analytical tools that provide insight into key quality attributes for synthetic programs. You will contribute to analytic method development, validation, transfer, and GMP testing of late‑phase drug substances and products.
Key Responsibilities
Define analytical control strategies and implement methodologies for pivotal phase clinical programs.
Develop, optimize, and authorize analytical methods for synthetic molecule release testing and characterization.
Collaborate closely with drug substance and drug product process development colleagues to achieve project objectives.
Provide analytical data to support drug substance and drug product development, including purity analysis, chiral purity, and structure elucidation using mass spectrometry.
Manage activities at contract manufacturing and testing sites.
Lead method transfer to CMO or contract testing labs when required.
Review and approve protocols and reports from CMO and contract testing labs.
Support project team lead in authoring technical reports and Analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents.
May lead and develop a small group of scientists.
What We Expect Of You The analytical professional we seek is an emerging Scientist with the following qualifications.
Basic Qualifications
Bachelor’s degree and 5 years of scientific experience, or
Master’s degree and 3 years of scientific experience, or
Doctorate degree (PhD, PharmD, MD) and relevant post‑doctoral experience.
Preferred Qualifications
PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, or Chemical Engineering.
2+ years post‑PhD experience in the pharmaceutical or biotech industry in process development and drug substance/product analytical method development.
Strong understanding of small‑molecule analysis, structure elucidation, solid‑state characterization, and organic chemistry.
Proficiency in liquid chromatographic and mass spectroscopic analysis.
Experience with MS, NMR, UV, FTIR, and related physicochemical techniques.
Experience developing and implementing methods for in‑process, release, and stability testing.
Familiarity with USP monographs, ICH/FDA guidance on analytical method transfer, validation, impurities, and mutagenic impurities.
Solid understanding of GLP and GMP requirements and their application in a phase‑appropriate manner.
Experience with technical transfer for non‑GMP and GMP production and testing to external contract organizations.
Strong communication skills and ability to provide cross‑functional leadership and guidance to CMC and non‑clinical teams.
Excellent technical writing skills with attention to detail in authoring methods, specifications, technical reports, and regulatory filings.
What You Can Expect From Us Amgen offers a competitive compensation and benefits package, including a Total Rewards Plan, health and welfare plans, financial plans, flexible work models, and career development opportunities. In addition to the base salary, we provide annual bonuses, stock‑based incentives, and generous retirement contributions.
Equal Opportunity Statement 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. We provide reasonable accommodation for individuals with disabilities.
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