Amgen Scientist-Pre-Pivotal Drug Product (Process Development) in Thousand Oaks, California
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.
Scientist-Pre-Pivotal Drug Product (Process Development)
What you will do
Let’s do this. Let’s change the world. In this dynamic role you will support our diverse early-stage portfolio projects that support different therapeutic modalities (bispecific/multispecific, fusion proteins, mAbs, oligonucleotides). Responsibilities include:
Plan, design, implement, and document stability studies related to FIH formulation development and fill/finish process development, in support of product commercialization.
Responsible for design and implementation of in use compatibility studies for clinical to mimic clinical dose preparation and administration
Conduct stability studies, to support liquid and lyophilized formulations. This will require knowledge of ultrafiltration-diafiltration and other buffer exchange processes.
Implement development of multi-modality protein drug formulations and analytical characterization of proteins via HPLC/UPLC methods, subvisible particle analysis, viscosity characterization, mass spectrometry, capillary electrophoresis.
Active participation and representation of drug product process development group in cross-functional project teams across organization
Continuous adherence to compliance and legal requirements while meeting organization’s goals and priorities
Author/review guideline documents, technical protocols, technical transfer documentation, reports, product impact assessments, and regulatory sections in support of IND submissions
Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs
Meticulous data collection, documentation using electronic data capture systems
Ability to work in a matrixed team and present data cross functionally
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Scientific professional we seek is a collaborative partner with these qualifications.
- Doctorate degree OR Master’s degree and 4 years of scientific experience OR Bachelor’s degree and 6 years of scientific experience
PhD in Pharmaceutics, Biotechnology, Biochemistry, Physical Biochemistry, or related subject area with a minimum of 2+ years of post-doctoral or industrial experience in pharmaceutical/biotechnology or related field
Understanding of physical/chemical stability of proteins and how process related stress impacts product quality
Experience in antibody characterization, stability, and experience in development of parenteral control release delivery systems
Understanding of predictive methods, protein stability and solubility
Experience in mass spectrometry (peptide mapping), physiological relevant assay characterization (for subcutaneous drug delivery)
Understanding of drug delivery and devices related to product development
Proficiency in a statistical software (such as JMP), experience with data visualization tools or packages (Tableau or Spotfire)
Ability to learn and act on dynamic information at a rapid pace, hard-working and collaborative mentality
Excellent oral and written communication skills for timely documentation, presentation, and discussion of scientific results for a fast pace and cross functional environment.
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 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.
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.