Intern - Quality Control

Location
Rensselaer, New York, US
Posted
Oct 10, 2018
Ref
14507BR
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Part time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Project Description: This internship will enable the intern(s) to understand the processes by which instrumentation and automated assays are validated in a GMP lab. Through this process the intern(s) will learn the CFR, FDA and ICH regulations which guide companies toward GMP compliance. The intern will learn the significance of Installation Qualification(IQ), Operational Qualifications (OQ) and Performance Qualifications(PQ) as they pertain to instrumentation, and the process of validation for each step. The interns will then learn the process of qualification and validation for bio and /or bioassays as they transfer from manual to automated systems. Computer programing for automation, design of experiment, statistics, qualification testing, protocol writing and validation execution will be included. Part of this project involves individual platform development work under the guidance of a scientist/ SME's. It also involves group interaction in the presentation of data and interface with other departments such as QA, equipment, validation, and doc compliance. This internship requires some back ground in engineering/instrumentation, computer programming and biological assay. The intern will be able to perform basic computer programming, test standard performance parameters (ex:SoftMax) for engineer functions and have a working understanding of the science behind different bioassays.

Project Deliverable and Goal: This internship will provide the opportunity to learn CE (Capillary Electrophoresis) based assay validation and optimization, and compendial method evaluation. The goal of this internship is to evaluate the method for readiness for validation, optimization, robustness parameter evaluation and the statistical analysis of data for specified molecule/molecules. The intern will gain the knowledge of ICH (International Conference on Harmonization) guidelines on assay validation, method optimization, statistical analysis, detailed design and construction of validation protocol, and protocol execution. At the end of the internship, the intern will have the opportunity to present their work to an audience compromise with multiple departments within Regeneron.

Objectives:

• Perform and evaluate a robustness study for a CE assay which is used in the RGN QC labs.

• Obtain data, statistical review and generate report for CE robustness study.

Desired Majors and/or Skills:
- Biochemistry, Chemistry, Biology, Pharmaceutical Sciences or related field.

Desired Education Level:
- Rising Soph., Rising Jr., Rising Sr.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.