Process Development Associate Scientist

Amgen Inc. (IR); Thousand Oaks, Northern (CA, KY); Hybrid; USD 90,000 - 122,000; Full time

Job summary

Amgen Inc. in Thousand Oaks, CA is seeking a Process Development Associate Scientist to join the Pivotal Drug Product Technologies group.

You will collaborate with engineers and scientists to advance formulation and fill/finish processes supporting late-stage biologics. Responsibilities include planning studies, executing laboratory work with high precision, analyzing analytical data, and building data visualizations.

Qualifications

• Master’s degree and 1 year of Scientific experience OR Bachelor’s degree and 3 years of Scientific experience.
• Preferred: Degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related field.
• Experience in pharmaceuticals/biotechnology with process characterization and formulation development is a plus.

Responsibilities

• Plan and design formulation and process development studies.
• Execute and document lab studies with high accuracy (UF/DF, filtration, freeze-thaw, stability).
• Analyze product/process performance with analytical testing.
• Build data analytics and visualizations using dashboard tools.
• Author/review technical protocols and reports.

Skills

Statistical software (SAS/JMP)

Programming (Python/R/MATLAB)

SQL

Data visualization (Tableau/Spotfire)

Education

Master’s degree + 1 year in Scientific experience

Bachelor’s degree + 3 years in Scientific experience

Tools

JMP

SAS

Minitab

Spotfire

Job description

Process Development Associate Scientist### Process Development Associate ScientistApply: On Site: US - California - Thousand Oaks: Full time: Posted Today: R-255613## **Career Category**Operations## ## **Job Description**## ## Join Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.**Process Development Associate Scientist**## ## **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 Associate Scientist 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## **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 go getter with these qualifications.**Basic Qualifications:**Master’s degree and 1 year of **Scientific** experience OR Bachelor’s degree and 3 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)## **What you can expect of us**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, we’ll 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 will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:* A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts* A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan* Stock-based long-term incentives* Award-winning time-off plans* Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.## ## Apply now and make a lasting impact with the Amgen team.## **careers.amgen.com**In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.## ## Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.## ## SponsorshipSponsorship for this role is not guaranteed.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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.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, disability status, or any other basis protected by applicable law.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..**Salary Range**90,442.55USD -122,363.45 USD