Process Development Scientist - Material Attributes and Technologies
- HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you are part of something bigger, its because you are. At Amgen, our shared mission - to serve patients - drives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve together - researching, developing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for you to make the impact you can be proud of. Join us today!
Process Development Scientist Material Attributes and TechnologiesLive
What you will do
Lets do this. Lets change the world. In this vital role you will be part of a global multidisciplinary group, with responsibilities including (but not limited to) developing analytical methods for raw materials, process reagents, and formulation excipients that are used in manufacturing protein therapeutic drug products. Our group works end-to-end across process development, and you will contribute to programs from First in Human clinical trials through Commercialization, Marketing Application and post approval. You will also have opportunity to collaborate with cross-functional partners in drug substance, drug product, device, manufacturing, quality, and regulatory functions.
- Work in a laboratory setting providing analytical leadership and expertise to develop release and characterization methods for raw materials, impurities, in-process, drug substance, and drug products samples
- Design and execute experiments using various analytical techniques such as liquid chromatography / mass spectrometry (LC/MS), high performance liquid chromatography (HPLC), high performance ion chromatography (HPIC), inductively coupled plasma / mass spectrometry (ICP/MS), and biophysical techniques for protein and particle characterization
- Provide results to support regulatory submissions, scientific publications, and patents
- Enable method validation and transfer to Amgen manufacturing sites around the world, and/or to external CRO/CMOs
- Bring Innovation with a positive approach to challenges and champion new insights and initiatives
- Collaborate with other scientists and keep current with both the literature and technology associated with the field of expertise
- Participate in external scientific engagements to showcase Amgens science and innovation
- Manage and mentor research associates and laboratory assistants
What we expect of you
We are all different, yet we all make our unique contributions to serve patients. The self-starting and motivated professional we seek is a scientist with these qualifications:Basic Qualifications:
- Doctorate degree
- Masters degree and 4 years of directly related experience
- Bachelors degree and 6 years of directly related experience
- Masters or Ph.D. in biochemistry, chemistry, analytical chemistry, physical chemistry, chemical engineering, or other life science areas plus 3+ years of post-graduate experience
- Scientist with 5+ years of experience in driving analytical deliverables for biopharmaceutical process and product development
- Knowledge and expertise in raw materials, process reagents, process-related impurities, and formulation excipients, including knowledge of the function of different chemicals, media components, and excipients in pharmaceutical manufacturing
- Knowledge in material attributes, bioprocessing, formulation, process reagents and excipients characterization, organic chemistry, protein characterization
- Knowledge with process and product attributes including aggregation, particles, process reagents and impurities from upstream, downstream, fill finish, primary containers and delivery systems
- Direct experience and expertise in analytical techniques such as HPLC, GC, IC, MS, ICP-MS, and biophysical techniques
- Knowledge in ICH guidelines, compendia monographs and methods, and cGMP
- Knowledge in analytical method development, qualification, and transfer
- Excellent communication skills, problem-solving skills, organizational skills, and ability to collaborate effectively and work in teams
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. You will have:
- 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.
careers.amgen.comEqual Opportunity Statement
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.
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Please note that you should be in your current position for at least 18 months before applying to internal positions. Staff must notify their current manager if invited for an interview. In addition, Staff are ineligible to apply for open positions if (a) their performance is currently being managed on a performance improvement plan (PIP) or other locally utilized formal coaching document or (b) their most recent performance rating was not a Partially Meets Expectations or higher. Please visit our Internal Transfer Guidelines for more detailed information.GCF Level
GCF Level 05Career Category
Process DevelopmentPosition Type
Join UsIf 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.