Process Development Scientist
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.
Process Development ScientistLive
What you will do
Lets do this. Lets change the world. In this vital role you will be part of our Pivotal Drug Product Technologies organization in the Thousand Oaks, CA headquarters. This group is responsible for late stage drug product formulation and process development for biologics modalities. The Scientist will provide technical and project leadership, integrating effective cross functional collaboration, to ensure success through the Drug Product commercialization process and lifecycle management. Platform capabilities, prior product knowledge, modeling, and data analytics/visualization will be applied to advance Amgens pipeline.The responsibilities for this role will include:
- Participate in Drug Product Commercialization Teams responsible for conducting process development of pipeline products and for supporting commercial products through lifecycle management
- Design, plan, execute, and document formulation and process development studies
- Apply scientific/engineering principles and techniques to develop, characterize and implement processes and next generation technologies and to tackle technical challenges
- Apply sophisticated statistical/data analytics techniques to draw conclusions and make informed decisions
- Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for process changes/improvements and non-conformance investigations
- Author/review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
- Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs
- Appropriately and consistently update management, cross-functional partners and relevant business partners on progress towards objectives and forthcoming program needs.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The biotech/pharma scientific professional we seek is a team-player with these qualifications.
- Doctorate degree OR Masters degree and 4 years of scientific experience OR Bachelors degree and 6 years of scientific experience
- Advanced degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Chemistry, Materials Science, Pharmaceutics or related subject area
- Experience in pharmaceutical development and manufacturing
- Experience in biologics process development, formulation development, fill-finish process engineering, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
- Experience with development and characterization of co-formulations
- Experience with sophisticated drug delivery, e.g. sustained release technologies, targeted delivery systems, microfluidics
- Experience with programming (e.g. Python, R, MATLAB) and database languages (e.g. SQL), as well as data visualization tools (e.g. Tableau, Spotfire, D3js)
- Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)
- Proficiency in problem solving, critical thinking, and independent research skills
- Strong project management skills, including the ability to handle ones project resources (material, manpower, time, etc.)
- Good organizational skills with strong attention to detail
- Strong ability to operate well in a fast-paced, matrixed environment and collaborate optimally cross-functionally
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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith 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.
#operations21Equal 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.Amgen requires all staff in the United States and Puerto Rico 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.