Grad Intern - OPS - (Global Quality Engineering - Parametric Distribution Library)

West Greenwich, RI, US
Mar 19, 2021
Required Education
Position Type
Full time
Amgen's 10 - 12 week internship program offers meaningful project experiences that impact patient's lives. This internship provides the opportunity for executive and social networking events and to participate in community volunteer projects while providing a competitive compensation.

Project Background: FDA Guidance for Industry on Process Validation includes a discussion on Continued Process Verification (CPV), which is considered the third stage of validation. The goal of CPV is to provide continual assurance that the process remains in a state of control, i.e., the validated state, during commercial manufacture. Companies must establish an ongoing program to collect and analyze suitable data that contribute to product quality, using techniques that are appropriate to evaluate process stability and process capability. To this end, Amgen's CPV strategy includes the deployment of product and process monitoring programs and periodic assessments of product performance for hundreds of product quality attributes. The accurate use of appropriate statistical tools and techniques is paramount to an effective CPV program. One important consideration is to identify a parametric distribution, e.g., normal, lognormal, Weibull, or Poisson, that will adequately approximate the distribution of the data.

Internship Project: The intern will build a documented library of parametric distributions for key product quality attributes for Drug Substance, Drug Product, and Final Drug Product. The library shall include the name of the product form and parameter, the recommended parametric distribution that best approximates the data and statistical software used at Amgen that supports the fitting and usage of the distribution. The intern will collaborate across multiple groups to gain a broad understanding of the biologics manufacturing processes, identify key product quality parameters and locate available data sources. Statistical software, along, with scientific knowledge, will be used to fit and evaluate appropriate distributions for both continuous and discrete data. The distribution shall be used to calculate the process capability index, Ppk, and establish control limits using Shewhart process control charts. The intern will gain experience in collecting and applying relevant statistical tools used in CPV that span the value chain of Amgen operations.

Limited relocation housing and/or miscellaneous allowance may be available for eligible candidates.

Basic Qualifications

Amgen requires that all individuals applying for a grad internship or a co-op assignment at Amgen must meet the following criteria:

18 years or older

Graduated with a Bachelor's degree from an accredited college or university with a 3.0 minimum GPA or equivalent

Completion as a first year graduate student before internship starts and currently enrolled in a Master's program for a Masters internship OR a PhD for a PhD internship from an accredited college or university

Enrolled in an accredited college or university following the potential internship or co-op assignment

Must not be employed at the time the internship starts

Preferred Qualifications

Pursuing an advanced degree program in Applied Statistics, Industrial Statistics or Non-clinical Biostatistics.

Proficient in Statistical Process Control, Process Capability Analysis and distributions appropriate for continuous and discrete data. Familiar with statistical tools and techniques commonly used in biopharma manufacturing operations, such as, Design of Experiments, Measurement System Analysis, Linear Regression and Significance Tests.

Proficient in SAS programming (data manipulation techniques, macro, statistical and graphical PROCs, and ODS) and JMP statistical software. Knowledge of R macros is a plus.

Demonstrate good teamwork, problem solving, organization skills, and the ability to adapt to changes quickly when required!

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.

Only candidates who apply via will be considered. Please search for Keyword 112167.


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.