Amgen

Process Development Senior Scientist. Expand and develop skills in cell culture and purification, thereby further contributing to the integrated group. Author, or provide direction for the authorship of, technical report or CMC regulatory submissions which may require minimal additional editing. Consistent track record of decision-making and trouble-shooting protein drug substance purification processes, preferably in a process development environment. Strong understanding and extensive hands-on experience in protein chromatography, including affinity, ion exchange, and hydrophobic interaction chromatography

process development

HOW MIGHT YOU DEFY IMAGINATION?
You’ve 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 mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s 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
Let’s do this! Let’s change the world! In this vital role you will be responsible for development, characterization, scale-up and support of drug substance processes to enable commercial advancement of programs from Ph II/III clinical trials to marketing application.
Apply established platform approaches and problem-solving skills to rapidly tackle drug substance challenges and build robust processes with efficient experimentation
Drive innovation and utilize out-of-the-box thinking to contribute to technology development
Expand and develop skills in cell culture and purification, thereby further contributing to the integrated group
Participate in drug substance teams and collaborate cross functionally with analytical and drug product representatives to deliver drug substance manufacturing processes in a phase appropriate manner.
Deliver process amenable to cGMP operation and carry out results of drug substance in a cGMP manufacturing environment
Author, or provide direction for the authorship of, technical report or CMC regulatory submissions which may require minimal additional editing
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The motivated professional we seek is an energetic candidate with these qualifications.
Basic Qualifications:
High school diploma / GED and 12 years of Engineering experience OR
Associate’s degree and 10 years of Engineering experience OR
Bachelor’s degree and 5 years of Engineering experience OR
Master’s degree and 3 years of Engineering experience OR
Doctorate degree (completed degree by 7/2024)
Preferred Qualifications:
Doctorate in Chemical Engineering, Biochemical Engineering, or other relevant sciences
Consistent track record of decision-making and trouble-shooting protein drug substance purification processes, preferably in a process development environment
Strong understanding and extensive hands-on experience in protein chromatography, including affinity, ion exchange, and hydrophobic interaction chromatography
Experience in filtration operations, including ultrafiltration/diafiltration
Understanding of protein characteristics and critical attributes to direct product/process control strategies
Proven ability to independently identify, develop and implement scientific solutions to practical problems.
Motivated self-starter with excellent interpersonal and organizational skills
Leadership experience of progressively increased scope and ability to encourage and lead a group of scientists
community through a sustained record of peer reviewed publications
Demonstrated success working with diverse team members in a dynamic, cross-functional environment
Familiarity with design of experiments and statistical analysis of data
Knowledge of license applications and the drug development process
Exposure to cGMP manufacturing and CMC components of regulatory submissions
Thrive
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.
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 plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
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
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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