GMP Molecular Analyst
Charles River Laboratories International Inc (CRL)
Hanover, MD, US, 21076
GMP Molecular Analyst Req ID #: 205831 Location:
Hanover, MD, US, 21076 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.
We are seeking an GMP Molecular Analyst for our Cell Therapy Facility located Hanover, MD.
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.
The following are responsibilities related to the GMP Molecular Analyst:
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
The following are minimum qualifications related to the GMP Molecular Analyst position:
BS or higher degree in the biological sciences or related field. 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.
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.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.
Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [email protected] This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit www.criver.com.
Nearest Major Market: Baltimore
Job Segment: Biology, Molecular Biology, Pharmaceutical, Statistics, Laboratory, Science, Data
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