BioSpace
Process Development Senior Scientist Analytical Development
BioSpace, Thousand Oaks, California, United States, 91362
Process Development Senior Scientist Analytical Development
Join to apply for the Process Development Senior Scientist Analytical Development role at BioSpace What You Will Do
Join the Pivotal Attribute Sciences Department in Thousand Oaks, CA. This group is responsible for late phase analytical development, including method development, method validation, method transfer, process and product development support, and GMP testing of late phase drug substances and drug products. Work closely with a team of analytical chemists, organic chemists, and formulation scientists responsible for the technical aspects of developing analytical tools to gain understanding of key quality attributes in product and process for late phase synthetic programs. Integrate and utilize platform and in-depth product attribute knowledge to advance Amgen products and ensure success through pivotal clinical phases to marketing authorization application. Define analytical control strategies and implement methodologies for development of pivotal phase clinical programs. Develop, optimize, and authorize analytical methods for synthetic molecules release testing and characterization. Collaborate 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; may lead method transfer to CMO or contract testing labs; review and approve protocols and reports from CMO and contract testing labs. Support project team lead to author technical reports and analytical CMC sections in regulatory documents; may lead and develop a small group of scientists. What We Expect Of You
We are all different, yet we all use our unique contributions to serve patients. The analytical professional we seek is an emerging Scientist with these qualifications. Basic Qualifications
Bachelors degree and 5 years of scientific experience, or Masters degree and 3 years of scientific experience, or Doctorate degree (PhD) or PharmD or MD with relevant post-doc where applicable Preferred Qualifications
PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering 2+ years post-PhD experience in the pharmaceutical or biotech industry in process development and drug substance, drug product analytical method development Strong understanding of small molecule analysis, structure elucidation and solid-state characterization guided by knowledge of organic chemistry Strong experience in liquid chromatographic and mass spectrometric analysis Experience with MS, NMR, UV, FTIR and other structure elucidation and physicochemical techniques Developing and implementing methods for in-process testing, release and stability testing Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities Solid understanding of GLP and GMP requirements and their application in a phase-appropriate manner Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage deliverables against timelines Strong communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams; capable of working across geographic locations and time zones Excellent technical writing skills and attention to detail in authoring methods, specifications, technical reports and regulatory filing documents What You Can Expect From Us
We support professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we will support your journey every step of the way. The salary range is posted and actual salary varies based on factors including skills and experience. Amgen offers a Total Rewards Plan including health and welfare plans, retirement savings, bonuses, stock-based incentives, time-off programs, and flexible work models where possible. 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. We will provide reasonable accommodation to applicants with disabilities in the job application or interview process and to perform essential job functions. Please contact us to request accommodation.
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Join to apply for the Process Development Senior Scientist Analytical Development role at BioSpace What You Will Do
Join the Pivotal Attribute Sciences Department in Thousand Oaks, CA. This group is responsible for late phase analytical development, including method development, method validation, method transfer, process and product development support, and GMP testing of late phase drug substances and drug products. Work closely with a team of analytical chemists, organic chemists, and formulation scientists responsible for the technical aspects of developing analytical tools to gain understanding of key quality attributes in product and process for late phase synthetic programs. Integrate and utilize platform and in-depth product attribute knowledge to advance Amgen products and ensure success through pivotal clinical phases to marketing authorization application. Define analytical control strategies and implement methodologies for development of pivotal phase clinical programs. Develop, optimize, and authorize analytical methods for synthetic molecules release testing and characterization. Collaborate 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; may lead method transfer to CMO or contract testing labs; review and approve protocols and reports from CMO and contract testing labs. Support project team lead to author technical reports and analytical CMC sections in regulatory documents; may lead and develop a small group of scientists. What We Expect Of You
We are all different, yet we all use our unique contributions to serve patients. The analytical professional we seek is an emerging Scientist with these qualifications. Basic Qualifications
Bachelors degree and 5 years of scientific experience, or Masters degree and 3 years of scientific experience, or Doctorate degree (PhD) or PharmD or MD with relevant post-doc where applicable Preferred Qualifications
PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering 2+ years post-PhD experience in the pharmaceutical or biotech industry in process development and drug substance, drug product analytical method development Strong understanding of small molecule analysis, structure elucidation and solid-state characterization guided by knowledge of organic chemistry Strong experience in liquid chromatographic and mass spectrometric analysis Experience with MS, NMR, UV, FTIR and other structure elucidation and physicochemical techniques Developing and implementing methods for in-process testing, release and stability testing Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities Solid understanding of GLP and GMP requirements and their application in a phase-appropriate manner Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage deliverables against timelines Strong communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams; capable of working across geographic locations and time zones Excellent technical writing skills and attention to detail in authoring methods, specifications, technical reports and regulatory filing documents What You Can Expect From Us
We support professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we will support your journey every step of the way. The salary range is posted and actual salary varies based on factors including skills and experience. Amgen offers a Total Rewards Plan including health and welfare plans, retirement savings, bonuses, stock-based incentives, time-off programs, and flexible work models where possible. 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. We will provide reasonable accommodation to applicants with disabilities in the job application or interview process and to perform essential job functions. Please contact us to request accommodation.
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