Career Category
Process DevelopmentJob Description
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.
Process Development Scientist
Live
What you will do
Let’s do this. Let’s change the world. In this dynamic role you will be contributing to our diverse process development portfolio projects that support different therapeutic modalities (Fusion proteins, mAbs, bispecifics, oligonucleotides). Responsibilities include:
- Planning, designing, implementation, and documentation of laboratory studies related to formulation and fill/finish process development in support of product commercialization
- Conducting stability studies, including preparation of liquid and lyophilized formulations. This will require knowledge of ultrafiltration-diafiltration and other buffer exchange processes. Collect analytical data to support product characterization and documentation
- Implementing development of protein drug formulations and analytical characterization of proteins
- Active participation and representation of drug product process development group in cross-functional project teams across organization
- Planning, design, and implementation of stability studies (including in use compatibility studies and FIH formulation studies), process development and design.
- 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 and analysis
- Ability to work in a matrixed team and present data cross functionally
Win
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.
Basic Qualifications:
- Doctorate degree OR Master's degree and 4 years of Scientific experience OR Bachelor's degree and 6 years of Scientific experience.
Preferred Qualifications:
- PhD in Pharmaceutics, Biotechnology, Biochemistry, Physical Biochemistry or related subject area with a minimum of 2-4 years of industrial experience
- Proficiency and hands on experience in Analytical and Biophysical techniques, such as HPLC/UPLC, Capillary Electrophoresis, Particle analysis, Biophysical techniques such as Fluorescence, Analytical centrifugation, light scattering (DLS, SLS), Conformational Stability (DSF, DSC) etc
- Experience in antibody characterization, stability and experience in development of parenteral control release delivery systems
- Strong independent problem solving and interpersonal skills
- Sophisticated understanding of predictive methods, protein stability and solubility
- Ability to learn and act on dynamic information at a rapid pace; passion and collaborative mentality and excellent interpersonal skills across cross-functional teams
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 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
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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