Process Development Sr Scientist - Thousand Oaks

Job DescriptionATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.Process Development Sr ScientistWhat you will doLet’s do this. Let’s change the world. In this vital role you will join Amgen’s Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes state-of-the-art analytical tools to guide that development. The Pivotal PD organization’s focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including (but not limited to) synthetic medicines, monoclonal and bispecific antibodies, bispecific T-cell engagers, and live oncolytic viruses. Located at our Thousand Oaks, CA office, the PD Senior Scientist will work to provide strategic analytical leadership (as an Attribute Sciences team lead) to teams developing commercializable manufacturing processes and collaborate closely with Drug Substance and Drug Product colleagues.Supervise and provide technical support for a team that provides analytical support for late stage product developmentAct as an Attribute Sciences Team lead for a program in pivotal clinical process development, being responsible for all analytical work to support the programDefine the analytical target profile (ATP) for methods used to monitor product quality. Based on the ATP, oversee the development, qualification, remediation, and transfer of analytical methods to Quality ControlManage activities at contract manufacturing and testing sitesAuthor technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Answer analytical and product quality questions from health authoritiesDrive product characterization in support of process comparability studies, regulatory filings, regulatory questions, and reference standard qualificationProvide expertise and evaluation of Amgen’s platform and analytical technologies, helping to drive innovation and efficiency within Process DevelopmentHelp to define strategies that improve the effectiveness and efficiency of the Attribute Sciences departmentAuto req ID472922BRMinimum Education RequiredHigh School/GEDJob_CategoryEngineeringAdditional Qualifications/ResponsibilitiesWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The scientist professional we seek is an individual with these qualifications.Basic QualificationsDoctorate degreeORMaster’s degree and 2 years of directly related life science experienceORBachelor’s degree and 4 years of directly related life science experienceORAssociate’s degree and 8 years of directly related life science experienceORHigh school diploma / GED and 10 years of directly related life science experiencePreferred QualificationsDoctorate degree with 5-7+ years in Analytical Chemistry, Biochemistry or equivalent.Relevant experience working as part of a multidisciplinary team in a biopharmaceutical setting would also be an advantage.Strong background in analytical method development of biologics such as monoclonal antibodies and multispecifics.Proficient in other HPLC and CE methods such as reversed-phased HPLC, size-exclusion HPLC, ion-exchange HPLC, affinity HPLC, CE-SDS, and cIEFDemonstrate knowledge of regulatory requirements and guidelines and prior experience authoring or contributing to regulatory filings.Familiarity with commonly observed product quality attributes associated with therapeutic proteins (such as glycosylation, deamidation, oxidation, partial reduction etc.), and their characterization and quantification toolsStrong problem solving and effective multi-functional interpersonal skills.Ability to develop, validate, transfer and remediate methods for in-process, release and stability testingSolid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) requirements and their application in a phase appropriate mannerExperience in technical transfer for non-GMP and GMP production and testing to external contract organizations, managing deliverables against timelinesStrong communication skills and ability to provide cross-functional leadership and guidance to Chemistry, Manufacturing, and Controls (CMC) and non-clinical teams, e.g. informing and defending the Quality Target Product ProfileWorks well in cross-functional teams, and across various geographic locations in different time zonesExcellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documentsExperience with protein-based and live modality therapies is beneficial (monoclonal antibodies, bi/tri-specific antibodies, fusion proteins, gene therapy, etc.)A self-starter and team player with strong leadership and decision-making skillSalary Range126,066.05USD -170,559.95 USDCity*Thousand OaksState*CaliforniaJob CodePharmaceutical PharmaceuticalAffiliate SponsorAmgenSalary Range$75,000-$100,000