Sr Scientist
$126.07k - $170.56kDormont Manufacturing Co
Sr Scientist What you will do In this vital role you will work in our Pivotal Drug Product Technologies Group in Thousand Oaks, CA. This group is responsible for late stage drug product formulation and process development for biologics modalities. The Scientist will provide technical and project support, integrating effective cross‑functional collaboration, to ensure success through the Drug Product commercialization process and lifecycle management. Platform capabilities, prior product knowledge, modeling, and data analytics/visualization will be applied to advance Amgen’s pipeline. Responsibilities Participate in Drug Product Commercialization Teams responsible for conducting process development of pipeline products and for supporting commercial products through lifecycle management Design, plan, complete, and document formulation and process development studies Apply scientific/engineering principles and techniques to develop, characterize and implement processes and next generation technologies and to solve technical challenges Apply advanced statistical/data analytics techniques to draw conclusions and inform decisions Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for process changes/improvements and non‑conformance investigations Author/review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs Effectively and consistently communicate with management, cross‑functional partners and relevant team members on progress towards achievements and forthcoming program needs. Lead cross functional initiatives enhancing Pivotal Drug Product platforms Manage and contribute to process design improvement projects Ability to travel domestically and internationally up to 10% of the time Qualifications Basic Qualifications: Doctorate degree (PhD, PharmD, or MD) OR Master’s degree and 3 years of Scientific experience OR Bachelor’s degree and 5 years of Scientific experience Preferred Qualifications: Degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Chemistry, Materials Science, Pharmaceutics or related field Experience in pharmaceutical development and manufacturing Experience in biologics process development, formulation development, fill‑finish process engineering, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments Experience with development and characterization of formulations and drug product manufacturing processes Experience with programming, application of AI‑enabled tools as well as data visualization tools (e.g. Tableau, Spotfire, D3js) Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab) Critical thinking, problem solving and independent research skills Strong project management skills, including the ability to manage one’s project resources (material, workforce, time, etc.) Good organizational skills with strong attention to detail Strong ability to operate well in a fast‑paced, matrixed environment and collaborate successfully cross‑functionally Benefits Amgen offers a Total Rewards Plan, comprising of 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. 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, and 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 where possible. Refer to the Work Location Type in the job posting to see if this applies. Salary Range
USD 126,066.05 – 170,559.95
Equal Opportunity Employer 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 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. #J-18808-Ljbffr Dormont Manufacturing Co- ...Machine Learning Scientist What you will do Within Amgen’s Research and Development organization, the Therapeutic Protein Design (TPD) team supports the broad goal of advancing and applying computational protein design to revolutionize how biologic therapeutics are made...SeniorFlexible hours
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