What are the responsibilities and job description for the GMP Molecular Analyst position at Charles River Laboratories?
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
IMPORTANT: In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process. Please make sure work history and education are added correctly.
Job Summary
The successful candidate will be responsible for performing routine quality control product and raw material release testing as well as various biochemistry, molecular biology, and general laboratory techniques according to GMP.
The position requires the utmost attention to detail, very strong organizational skills, computer proficiency, and a basic understanding of laboratory instrumentation. In addition, effective communication skills and the ability to function in a fast-paced, highly technical environment with minimal supervision are essential for success.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Enters observations and results into the appropriate trending databases for periodic analysis and trending.
- Assists the GMP Analytical Team with maintaining proper overall operation of department (physical inventories, logs, documentation, filing, etc.) Maintains familiarity with relevant cGMP guidance’s(CFR, USP, EP, ICH, etc.).
- Assists with the implementation of quality improvement initiatives for GMP Analytical laboratory operations Participates in laboratory, OOS, CAPA or other investigations, as required.
- Maintains laboratory supplies, media and reagents inventory.
- Adheres to standard operating procedures and good documentation practices to ensure data integrity and traceability Responsible for assisting with routine laboratory upkeep and organization.
- Other duties as required.
Job Qualifications
- BS or higher degree in the biological sciences or related field with a minimum of 4 years relevant laboratory experience with 2-3 years’ experience in a cGMP/FDA regulated industry.
- 2-3 years of qPCR experience, preferably with the Quant Studio systems, including assay development and qualification.
- Previous experience working with aseptic techniques and culturing of mammalian cells and familiarity with cell culturing basics.
- Strong background and experience with cell-based immunological in vitro methods (e.g.. MLR, cytotoxicity, HLA-restriction, CTLp, cell proliferation, etc.) and instrumentation.
- Knowledge and technical expertise in areas of assay development, optimization and validation leveraging off-the-shelf technologies such as ELISA, flow cytometry, PCR/other molecular biology-based assays).
- Familiarity with cGMP as defined in 21CFR210 and 211. Ability to work independently and as part of a team.
- Study design, data/statistical analysis, reporting results in both written and oral format (presentation).
- An understanding of cGMP/GLP regulations as well as excellent documentation skills in order to complete paperwork dealing in all aspects of Quality Control Reviews test results of other GMP Analytical analysts for accuracy and precision and maintains efficient work flow of an required testing documentation ensuring timely submission relative to product release dates.
- Adheres to Good Documentation Practices.
- Detail-oriented with strong written and verbal communication skills.
- Ability to problem-solve and troubleshoot as necessary.
IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV.
Vaccine Mandate
Charles River is a U.S. Federal Contractor. As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19. Our main priority is the wellbeing, health, and safety of our people. We require proof of vaccination from all employees.
Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.
About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.
