Job Information
Amgen Process Development Associate Scientist in Juncos, Puerto Rico
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 Associate Scientist
What you will do
Let’s do this. Let’s change the world. In this vital role you will develop, characterize, and validate processes for Drug Product manufacturing facility. You will play a role in shaping strategies for new processes, equipment, and technologies, while ensuring compliance and precision in drug product packaging. Your capability will directly contribute to the successful introduction of new products, continuous improvement of existing systems, and alignment with the highest industry standards supporting a Non Standard Shifts Organization.
Specific responsibilities include but are not limited to:
Serve as the Subject Matter Expert (SME) for Packaging processes within the Drug Product Process Development (PD) organization.
Support new product introductions, process improvements, and the acquisition of new technologies, collaborating with manufacturing plants and packaging process.
Develop Change Control assessment of the introduction of new product introductions, process improvements, and the acquisition of new technologies.
Perform and support commissioning, characterization, and qualification of new and existing assets, implementing improvements based on lessons learned.
Investigate and implement corrective actions for process-related issues.
Develop and implement project plans and strategies to achieve specific goals and timelines.
Collaborate across teams (manufacturing, process engineering, maintenance, quality assurance, validation) to complete investigations and solve technical problems.
Author and review protocols, experiments, scientific technical reports, regulatory documents, and/or patents.
Contribute to a safe working environment, adhering to environmental, health, and safety practices.
Identify problems, develop solutions, and implement effective strategies under minimal supervision.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Process Development Associate Scientist professional we seek is an individual contributor with these qualifications:
Basic Qualifications
Master’s degree and 1 year of Process Development, Engineering and/or Manufacturing support experience
Or
Bachelor’s degree and 3 years of Process Development, Engineering and/or Manufacturing support experience
Preferred Qualifications
Educational background in Life Sciences or Engineering
Hands-on experience in process characterization, including testing strategies, protocol design, technical report development, validation execution, and risk assessment activities.
Leader in developing characterization and validation strategies with successful results.
Working knowledge of GxP regulations, user requirements, risk assessments, and test case development.
Hands-on experience in cGMP within a regulated industry, with a high quality and compliance mentality.
Available to work Non-Standard shifts, including nights, weekends or holidays when required, to meet project timelines and operational needs.
Excellent communication skills (oral and written), fully bilingual in Spanish and English.
Excellent time and project management abilities to deliver on schedule and budget.
Flexibility to adapt to changing project requirements and priorities.
Good problem solving and conflict resolution skills.
Proficient in computer applications (Word, Excel, PowerPoint, statistical software)
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
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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.