Process Development Scientist, Assay 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 Scientist - Assay Development

Live

What you will do

Let’s do this. Let’s change the world. In this role you will be doing the following:

• Developing and implementing innovative and fit-for-purpose analytical methods for: impurity release testing.
• Preparing technical reports for investigations, product and impurity characterization, and regulatory submissions
• Generating, analyzing, and interpreting analytical data to support: product development investigations, and regulatory submissions
• May participate or contribute to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation
• Keeps current in the analytical development field, including literature and technology development for groundbreaking and regulatory-driven activities
• Supporting analytical projects involving method development, qualification, and transfer
• Provides critical evaluation of analytical data and results to support: product development (for Process Development, Quality, etc.), investigations and regulatory submissions
• Participates in and contributes to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates and documentation.
• Providing critical evaluation of analytical data and results to support: product development (for Process Development, Quality, etc.), investigations and regulatory submissions

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek will possess these qualifications.

Basic Qualifications:

Doctorate degree

Or

Master’s degree and 2 years of Scientific experience

Or

Bachelor’s degree and 4 years of Scientific experience

And

Advanced and proficient understanding and use of technical principles, theories, and concepts to perform an expansive range of work in a role

And

Basic knowledge of related and adjacent disciplinary areas.

Preferred Qualifications:

• Experience and expertise with protein assays, particularly ELISA as well as most common formats for measuring protein-protein interactions.
• Experience and expertise with Microsoft Office software, particularly Word, PowerPoint and Excel.
• Experience with regulatory filings (IND, BLA, and NDA) and ICH Guidelines
• Innovation – positive approach to challenges; champions new ideas and initiatives; brings out and applies others’ creativity to improve unit performance
• Client orientation– establishes effective and responsive relationships with all clients; translates client requirements into work design; ensure value is delivered
• Communication – establishes and maintains effective communication mechanisms to keep staff appropriately informed; bridges communication between individuals, units and other organizations as necessary
• Interpersonal skills – communicates effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood

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.

Salary : $107,234 - $129,162