Senior Associate Scientist, Process Development (Analytical)
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
SENIOR ASSOCIATE SCIENTISTLive
What you will do
Lets do this. Lets change the world. In this vital Sr Associate Scientist role you will be an integral member of a dynamic team, collaborating with research scientists at multiple Amgen sites, and working closely with groups in other functional areas. This position reports to the Senior Scientist, Process Development within Pre-Pivotal AS and the role will be based out of Amgen's Headquarters in Thousand Oaks, California. Amgen is seeking a Process Development, Senior Associate Scientist. A largely laboratory-based position where focus will be on driving cutting-edge analytical support and technology development impacting process and product development teams across Amgens portfolio. Work cross-functionally and across R&D sites while using analytical science to help drive efficient development and scalable understanding of processes and products in Amgens pipeline.Primary job responsibilities for this role include the following:
- Analytical method development, validation and trouble-shooting for small molecule drug substances and drug products using LC/UPLC, GC, spectroscopic and dissolution techniques
- Perform development sample analysis for process development
- Perform testing following cGMP requirements for release and stability studies of drug substance and drug product
- Perform basic instrument maintenance and basic trouble-shooting
- Document, review results and maintain electronic laboratory notebooks
- Author, review and data verify technical documents, and presentations
- Keep updated with instrument automation/software systems, and other scientific and document systems required for the role
- Interact with drug substance, drug product and other clients for project needs, and communicating progress
- Provide training to other staff members in expertise areas
- Participate in method transfer and method trouble shooting at external testing labs, including reviewing data and report from external partners
- Work and adapt in a fast-paced and dynamic environment
- Follow good lab citizenship and contribute to maintaining a safe work environment
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The science professional we seek is a driven and collaborative team-player with these qualifications.Basic Qualifications:
Masters degree and 3 years of Scientific experience
Bachelors degree and 5 years of Scientific experiencePreferred Qualifications:
- Masters degree in Analytical Chemistry, Physical, Pharmaceutical, Life Sciences or Engineering
- 5+ years in the pharmaceutical or biotech industry
- Strong expertise in analytical method development, validation and trouble-shooting for small molecule drug substances and drug products using LC/UPLC, GC, spectroscopic and dissolution techniques
- Extensive experiences and solid theoretical understanding with chromatographic techniques (Liquid chromatography, gas chromatography, ion chromatography), titrations, vibrational spectroscopy (FTIR and UV), and dissolution techniques, including basic instrument trouble shooting
- Strong technical aptitude for the identification, development, and implementation of novel analytical technologies, such as Mass spectrometry (MS), NMR, Vibrational spectroscopy etc.
- Familiarity with automation and implementing data management systems; efficient to compile and communicate complex datasets in a manner in which facilitates informed decision-making
- Experienced in drug substance and drug product manufacture process support
- Experienced in GMP testing for release and stability; good understanding in GMP compliances
- Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment
- Strong abilities in trouble-shooting, problem solving, and multi-tasking in support of process chemistry and formulation efforts at the pivotal phase of development
What you can expect of us
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.
- Vast opportunities to learn and move up and across our global organization
- 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
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. 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.
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.