Process Development Principal Scientist

Career CategoryOperationsJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.Process Development Principal ScientistLiveWhat you will doLet’s do this. Let’s change the world. In this vital role you will work to provide strategic analytical leadership to teams developing commercial manufacturing processes for synthetic and hybrid Drug Products.Lead the attribute and analytical aspects of a program in pivotal clinical process development with a focus on drug product development while working cross-functionally within a Product development teamDefine analytical control strategies and implement methodologies for development of late phase clinical programs including analytical method development and optimizationLead method transfer and support of cGMP drug product manufacturing activities at internal manufacturing, and 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 departmentMaintain current in the analytical development field including literature and technology development for cutting edge and regulatory driven activities and apply this knowledge to the evaluation and development of new methodologiesRecognized as a scientific resource in area of expertise who can provide mentorship to junior staff.WinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.Basic Qualifications:Bachelor’s degree and 7 years of Scientific experience ORMaster’s degree and 5 years of Scientific experience ORDoctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 2 years of Scientific experiencePreferred Qualifications:Knowledge of analytical method development and testing requirements toward solid oral dosage support (immediate and controlled release solid dosage forms, liquid formulation or lyophilized formulation), including dissolution method development.Strong understanding of small molecule analysis including chromatographic and spectroscopic techniques with an emphasis toward separation science, Process Analytical Technologies (PAT) for process understanding and process control, structure elucidation and solid-state characterizationSolid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) requirements and their application in a phase appropriate mannerHands on experience in development, validation, transfer and remediation of methods for in-process, release and stability testingKnowledge of the major Pharmacopeia and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) guidance documents related to analytical method transfer and validation, impurities, genotoxic impurities, early phase development.Experience in technical transfer for non-GMP and GMP production and testing to external contract organizationsAbility to multitask managing deliverables on complex projects against timelinesStrong leadership, problem solving, decision making and communication skills with the ability to work cross-functionally and globally within CMC teams to deliver resultsExcellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documentsThriveWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.A discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comApplication deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation..Salary Range136,662.00 USD - 164,812.00 USDSummaryLocation: US - California - Thousand OaksType: Full time