Juncos, PR, 00777, USA
1 day ago
Process Development Senior Scientist - Filling
**Join Amgen’s Mission of Serving Patients** At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. **Process Development Sr. Scientist - Filling** **What you will do** Let’s do this! Let’s change the world. In this vital role you will conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor. Provides input to new processes to generate robust and reliable data and ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. **Specific responsibilities include but are not limited to** + Scientific leadership of Characterization/Validation activities for filling process, including development, planning and execution in support of regulatory filing, response to regulatory questions and process/analytical investigations. + Provides data analysis and interpretation, and assesses impact of the data + Provide commercial support as needed including deviation, corrective action and process improvements + Develops and implements new and novel protocols to address specific issues + May represent the department on project teams under supervision of a senior scientific staff member + May initiate productive collaborations within and outside of the department or company + Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents + Participates in external scientific community + May assume lead role in department-wide support efforts such as safety, recruiting and committees + Develops and follows timelines for completing project collaboration + Support non-standard operations including extended hours, as per business needs. + Provide support to regulatory inspections including presenting to auditors **What we expect of you** We are all different! Yet, we all use our unique contributions to serve patients. The Process Development Sr. Scientist professional we seek is a technical leader with these qualifications. **Basic Qualifications:** Doctorate degree OR Master’s degree & 3 years of Process Development, Research and/or Manufacturing support experience OR Bachelor’s degree & 5 years of Process Development, Research and/or Manufacturing support experience **Preferred Qualifications:** + Educational background in Mechanical or Chemical Engineering (strongly preferred) or Life Sciences. + Expertise in fluid mechanics and machine operations, particularly in filling processes within a parenteral manufacturing environment. + Strong knowledge of engineering principles, including computational fluid dynamics and process optimization. + Experience in Tech Transfer, Process Design, Characterization, and Process Validation, with a focus on filling operations. + Leadership abilities, capable of managing initiatives, driving projects, and engaging cross-functionally. + Analytical and problem-solving skills, with the ability to evaluate data, apply engineering principles, and develop innovative process solutions. + Excellent communication and presentation skills, with the ability to engage actively in meetings, lead discussions, and network effectively. + Technical writing expertise, including authoring technical reports, protocols, and regulatory documentation. + Proficiency in English and Spanish, with strong verbal and written communication skills. + Flexibility to support project implementations during non-standard shifts and weekends, as required. **What 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. In addition to the base salary, 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: + A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance + 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 and an annual site shutdown + Flexible work models, including remote work arrangements, where possible **Apply now** **for a career that defies imagination** Objects in your future are closer than they appear. Join us. **careers.amgen.com** In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. 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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