Process Development Associate Scientist

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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 Associate Scientist

Live

What you will do

Lets do this. Lets change the world. Amgen's Commercial Attribute Sciences group within Process Development is seeking an Associate Scientist. The Associate Scientist will serve as an analytical subject matter expert responsible for supporting troubleshooting method related issues across analytical platforms and modalities. The Associate Scientist will also be responsible for supporting implementation of new analytical technology, tech transfer/method transfer and investigations. This individual will be a key liaison between the local commercial AS team and QC team to ensure the site needs are addressed. The Associate Scientist will also collaborate with representatives from key functions within Process Development.

Commercial Attribute Sciences Associate Scientist Key Responsibilities:

• Interact and collaborate with other functional areas in matrix environment as an analytical subject matter expert
• Generate, analyze, and critically evaluate analytical data to support investigations and regulatory submissions
• Author and review technical reports and sections of regulatory filings.
• Support process and method lifecycle management, including testing to support method remediation, qualification and transfer as well as process improvements and new product introduction
• May participate or contribute to analytical development teams (e.g., Product delivery teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation
• Serve as deputy ASTL (Attribute Sciences Team Lead) on a commercial program
• Duties may include establishing timelines, achievements, methodological approaches, expected results, and necessary resources
• Partner with Quality Control to address testing challenges and find opportunities for improvement
• Develop digital tools to facilitate the access and visualization of data within Commercial Attribute Sciences

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:

• Masters degree in Biotechnology or related discipline & 2 years of Scientific experience Or
• Bachelors degree in Biotechnology or related discipline & 4 years of Scientific experience

Preferred Qualifications:

• Advanced understanding and hands-on experience in various analytical platforms applied to the analysis of pharmaceutical and biological products such as HPLC and CE techniques
• Excellent written and oral communication skills for the timely and detail oriented documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment
• Advanced ability to critically analyze and interrogate various analytical data sets to drive and influence the investigational process
• Advanced experience with Spotfire, Smartsheet and Data Bricks
• Strong presentation skills
• Understanding of product quality attributes, control strategies, quality attribute assessments, and Quality Target Product Profile throughout the lifecycle of a product
• Understanding of regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements
• Experience in applying troubleshooting and investigation methodologies for problem solving. This includes technical support for nonconformance investigations and other commercial support activities.
• Experience in developing and implementing methods for in-process, process characterization, and release testing
• Innovation positive approach to challenges; champions new ideas and initiatives
• Client orientation establishes effective and responsive relationships with all clients; translates client requirements into work design; ensures value is delivered
• Communication establishes and maintains effective communication mechanisms; works well in teams
• Interpersonal skills communicates effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood; works well in teams
• Active in external scientific community

Thrive

Some of the vast rewards of working here

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.

• 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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

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

careers.amgen.com
Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to 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.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.