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 Scientist - Drug Product
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 our Parenteral Drug Product manufacturing facility. Your work will include buffer preparation, compounding, filtration, product holds, and filling biologic products into vials and syringes. You'll become an expert in operating equipment like single-use and stainless steel tanks, transfer panels, mixers, filtration systems, vial and syringe filling lines.
You will be supporting a 24/7 formulation and filling operation including technical recommendations, data analysis, floor support, and product impact evaluation. Also, support new product introductions, process improvements, and technology acquisitions. Key tasks include conducting mixing studies, filtration rate analysis, and mass balance evaluations. Strong documentation skills are essential for preparing reports used in regulatory audits.
Specific responsibilities include but are not limited to:
Technical
Design and conduct experiments to optimize protein-based formulations, filling process, and support investigations.
Evaluate and interprets experimental results and provide recommendations based on scientific data using strong statistical methodologies.
Ensure all studies are in compliance with protocols, guidelines, and regulations.
Develop process characterization and validation strategies, ensuring alignment with company policies.
Manage process improvement projects to improve productivity and efficiency.
Provide on the floor day-to-day support to commercial operations, troubleshoot issues, and transfer knowledge to manufacturing teams.
Support technology transfers and lead research in complex areas.
Apply advanced technical principles to develop innovative solutions for process challenges.
Participate in or lead technical forums to share standard methodologies, improvements, and formulation process expertise.
May support or lead efforts with research, manufacturing, process development, utilities, facilities and quality assurance departments in developing requirements and recommendations for large and/or highly complex system/facility or process modifications
General
Prompt and regular attendance to the workplace. Although main working hours are regular administrative hours, the role may support non-standards shift structure.
Develop and implement project plans with cross-functional teams.
Communicate scientific/technical information internally and externally (e.g., regulatory agencies, conferences).
Contribute to or author scientific/technical documents (e.g., reports, publications, regulatory submissions).
What we expect of you
We are all different! Yet, we all use our unique contributions to serve patients. The Process Development Scientist professional we seek is an Individual Contributor with these qualifications.
Basic Qualifications:
Doctorate degree
Or
Master's degree and 2 years of Process Development and/or Technical Services experience
Or
Bachelor's degree and 4 years of Process Development and/or Technical Services experience
Preferred Qualifications:
Academic background in Life Sciences or Engineering (Biochemistry, Chemical Engineering, etc.).
Experience with protein science, formulation and filling processes.
Process Monitoring and statistical tools.
Experience in technology transfer and process validation life cycle.
Experience supporting deviations, product impact assessments, and floor support.
Bilingual in Spanish and English.
Strong communication, problem-solving, and project management skills.
Proficiency in Microsoft Office and JMP, and/or Minitab.
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.
