Process Development Senior Scientist
3 days ago
HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Process Development Senior Scientist
Live
What you will do
Lets do this Lets change the world
The Materials Science team within Attribute Sciences provides technical expertise and oversight of raw materials used to manufacture Amgens pipeline and commercial portfolio of biologic and synthetic therapies. The Senior Scientist will be responsible for providing subject matter expertise in the preparation, characterization, and performance of raw materials, particularly focusing on cell culture media and media supplements, and how these impact manufacturing process performance and product attributes. The Senior Scientist will perform a range of cross-functional activities such as support for the development of attribute-driven material specifications, evaluation of material-related risks, and technical assessments for investigations. This role will involve building and maintaining effective cross-functional collaborations with peers across Amgens internal network (e.g., Process Development, Manufacturing, Quality, Regulatory Affairs) and external suppliers, to ensure uninterrupted supply of fit-for-purpose raw materials to Amgen.
Represent the Materials Science function in cross-functional teams as technical subject matter expert for cell culture media and media supplements.Attribute Identification: Identify critical media attributes that impact process performance and product quality outcomes.Mitigate Raw Material Variability: Oversee efforts to understand and mitigate variability in raw materials to prevent impacts on manufacturing processes.Supplier Collaboration: Collaborate with external suppliers to understand their manufacturing processes and strategies for controlling material attributes.Technical Assessments: Provide technical assessments on the impact of supplier changes to raw material attributes.Root Cause Analysis: Support root cause investigations, evaluate supplier responses, and verify the effectiveness of corrective/preventive actions.Regulatory Compliance: Maintain awareness of global pharmacopeia requirements and their impact on Amgens portfolio. Collaborate on developing scientific strategies to handle updates to raw material pharmacopeia monographs.External Engagement: Represent Amgens position on raw material topics in external scientific engagements and industry forums.WinWhat we expect of you We 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:Bachelors degree and 5 years of Scientific experience ORMasters degree and 3 years of Scientific experience ORDoctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]Preferred Qualifications:Proven expertise in cell culture media development and related raw material attributes.Excellent communication skills (written and oral), including the ability to explain technical topics to non-technical colleaguesAbility to collaborate effectively and work in teams.Understanding of chemical synthesis, chemical manufacturing unit operations, and purification strategies.Knowledge of the function of different chemicals, media components, and excipients in pharmaceutical manufacturingExcellent analytical/problem-solving skillsGood organizational skillsBe able to multi-task and function in a dynamic environmentAbility to work with technical documents, perform data analysis, and identify critical missing informationThriveWhat you can expect of us As 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 imagination Objects in your future are closer than they appear. Join us. 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.-
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