Process Development Senior Associate

Basic Qualifications

Masters degree

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnesses drives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year.

Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based.

If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Lets do this. Lets change the world. In this vital role you will join the Pivotal Drug Product Technologies organization at Amgen develops, characterizes and supports the commercialization of the drug product manufacturing processes for all late-stage programs across the Amgen portfolio. Amgen is currently seeking a Process Development Senior Associate for our Pivotal Drug Product Technologies Group in Thousand Oaks, CA.

This group is responsible for late stage drug product formulation and fill/finish process development for large molecule modalities (e.g. monoclonal antibodies, bispecific T-cell engagers (BiTEs) and fusion proteins). The Sr. Associate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgens drug product commercialization and lifecycle management.

• Participate in the planning and design of formulation and process development studies by applying basic science/engineering skills and prior knowledge
• Participate in the execution and documentation of laboratory studies with a high degree of accuracy (e.g. UF/DF, filtration, freeze-thaw, stability)
• Evaluate product and process performance through analytical testing (e.g. U/HPLC, particle analysis, moisture content)
• Build a wide range of data and analytics solutions, from available commercial dashboarding tools such as TIBCO Spotfire, MS Smartsheet
• Perform data analysis using statistical analysis software (e.g. JMP, SAS, etc.)
• Apply advanced digital tools to automate data structuring, analyze large and diverse datasets and build intuitive visualizations.
• Author/review technical protocols and reports
• Participate in team meetings by sharing study designs, results and technical challenges

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Masters degree OR Bachelors degree and 2 years of Scientific experience OR Associates degree and 4 years of Scientific experience OR High school diploma / GED and 6 years of Scientific experience

• Degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related field
• 1+ years of experience in pharmaceuticals/biotechnology that includes process characterization, formulation development, equipment design and implementation, technology transfers
• Familiarity with pharmaceutical/biotechnology process development
• Knowledge of Drug Product unit operations (i.e. ultrafiltration/diafiltration, filling, filtration, mixing, etc.) and experience with relevant analytical techniques (i.e. SEC, CEX, HIAC, MFI)
• Understanding of physical/chemical stability of proteins and how process-related stresses impact molecule attributes and product quality
• Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)
• 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)
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and align with company policies
• Self-motivation, adaptability and a positive attitude
• Critical thinking, problem solving and independent research skills
• Good organizational skills with strong attention to detail
• Excellent communication (oral and written)

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary…