Process Development Scientist - Cambridge, United States - Amgen
Description
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
Live
What you will do
Let's do this. Let's change the world.
In this vital role you will be responsible for developing, qualifying, and transferring state-of-the-art and fit-for-purpose quantitative potency and biological characterization assays and supporting sample testing and regulatory submissions.
Responsibilities include:
- Developing stateoftheart and fitforpurpose analytical potency methods for: release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations
- 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
- Contributing 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. Supports analytical projects involving method development, qualification, and transfer.
- Designing and implementing analytical projects involving method development, qualification,
- Provides critical evaluation of analytical data and communicates/presents results to support product development (for Process Development, Quality, etc.),.), investigations and regulatory submissions.
- May supervise others within the group
Win:
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic Qualifications:
Bachelor's degree and 4 years of Scientific experience
OR
Master's degree and 2 years of Scientific experience
OR
Doctorate degree
Preferred Qualifications:
- Expertise in cell culture, and cell biology techniques for quantitative determination of biological activity of proteins
- Expertise in cellbased bioassay development (characterization methods, qualification, validation, technical transfer)
- Expertise with signal transduction, gene expression, receptor binding and fluorescent probe technologies Experience in molecular biology techniques to manipulate plasmid constructs for generation of transfected stable cell lines
- Innovation drives new ideas and initiatives
- Detail oriented and excellent documentation skills
- Experience with automated liquid handling preferred
- Client orientation
- Communication and Interpersonal skills communicates effectively with others, using appropriate diplomacy and sensitivity; make others feel respected, valued and understood; works well in teams
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.
- 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 salesbased incentive plan
- Stockbased longterm incentives
- Awardwinning timeoff plans and biannual companywide shutdowns
- Flexible work models, including remote work arrangements, where possible
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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.
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