Process Development Scientist Technology - Pre-Pivotal Attribute Science Details

Process Development Scientist Technology - Pre-Pivotal Attribute Science

Amgen - Thousand Oaks, CA

Employment Type : Full-Time

Career CategoryOperationsJob Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

Process Development Scientist Technology - Pre-Pivotal Attribute Science

What you will do

Let’s do this. Let’s change the world. In this vital role you will contribute to Amgen’s diverse process development portfolio of therapeutic modalities with a focus on understanding process and product properties of small and large molecule drug candidates being developed across multiple therapeutic areas in Amgen’s pipeline.

• Responsible for laboratory activities (e.g. therapeutic protein analytical method development, qualification, protein process and formulation support and method transfers) for assigned projects, including but not limited to developing timelines and work plans.

• Lead development and implementation of sophisticated analytical techniques both internally and through external collaborations.

• Routinely craft experiments that lead to a fundamental understanding of a therapeutic protein’s attributes and stability characteristics as a function of process development.

• Support drug substance and drug product process development and protein characterization, collects analytical data to be used for regulatory submissions, and participates in technology transfer activities to contract and/or manufacturing sites (internal and external).

• Prepare and review technical documents, including technical methods, drug stability and characterization reports and regulatory submission modules.

• Independently performs all technical assignments and is encouraged to troubleshoot analytical instrumentation.

• Investigates method performance, reliability, and improvement issues, and evaluates proposed changes to compendial or in-house methods.

• Makes routine use of scientific literature, and has a good understanding of the subject areas beyond biochemistry and pharmaceutics that also play into protein drug development including intellectual property (IP) protection, regulatory strategy, process technology, etc.

• Effectively functions as an Attribute Sciences representative on project teams. Responsibilities may include supervision and development of junior scientific staff members.

• Mentoring Jr analysts.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The highly motivated professional we seek is a scientist with these qualifications.

Doctorate degree

OR

Master’s degree and 4 years of directly related experience

OR

Bachelor’s degree and 6 years of directly related experience

• Ph.D. in biochemistry, chemistry, chemical engineering or other life science area plus 4 or more years of industrial experience.
• Experience in protein-protein interactions, separation sciences with mass spectrometry or sophisticated mass spectrometry.
• Familiarity with protein characterization techniques.
• Comfortable working with computer-based applications such as EDM Quality, EPIC, Electronic Lab Notebook, EDM Teams, etc.
• Capable of working independently with minimal direction.
• Ability to manage priorities and adjust schedule to accommodate changes. Experience authoring scientific protocols and technical reports.
• Prior experience authoring or contributing to regulatory filings.
• Track record of scientific achievement through publications and/or presentations at external scientific meetings.
• Independent, accountable, attention to detail, ability to optimally balance multiple projects, and good interpersonal/communication skills are required.
• Experience with MS Office suite of software (i.e., Word, PowerPoint, Excel) and collaborative tools (e.g., MS Teams, WebEx, Skype).

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey

• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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 a 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 an accommodation.