Process Development Senior Associate
Amgen
Summary
Let’s do this. Let’s change the world. In this vital role you will join our Pivotal Drug Product Technologies group in Thousand Oaks, CA. This group supports drug product commercial formulation development as well as formulation/fill/finish process development for Amgen’s Late-Stage biologics. The Sr. Associate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen’s drug product commercialization and lifecycle management.
Job description
What you will do
Let’s do this. Let’s change the world. In this vital role you will join our Pivotal Drug Product Technologies group in Thousand Oaks, CA. This group supports drug product commercial formulation development as well as formulation/fill/finish process development for Amgen’s Late-Stage biologics. The Sr. Associate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen’s 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
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
Basic Qualifications
Master’s degree OR Bachelor’s degree and 2 years of Scientific experience OR Associate’s degree and 4 years of Scientific experience OR High school diploma / GED and 6 years of Scientific experience
Preferred Qualifications
- 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. Familiarity with ADCs is preferred.
- 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)
Requirements
- Master’s degree OR Bachelor’s degree and 2 years of Scientific experience OR Associate’s 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. Familiarity with ADCs is preferred.
- 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)
Benefits
- Health insurance
- Dental coverage
- Vision coverage
- Retirement and savings plan
- Life insurance
- Disability insurance
- Flexible spending accounts
- Discretionary annual bonus
- Stock-based long-term incentives
- Paid time-off
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.