Research Scientist 2, Immunogenicity

Research Scientist 2, Immunogenicity Req ID #:  109080 Location: 

Shrewsbury, MA, US, 01545 For 70 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. Job Summary We are seeking a Research Scientist 2, Immunogenicity for our Safety Assessment site located in Shrewsbury, MA.  

The Research Scientist 2, Immunogenicity will serve as a scientist in the conduct of assigned nonclinical research studies of basic to moderate complexity, to include study management, interpretation and reporting of study data, and assuring the regulatory compliance of these projects.

Essential Duties and Responsibilities: Lead immunogenicity assay development, validation and bioanalysis.  Supervise and mentor laboratory scientists in designing, developing and validating ligand binding ADA and Nab bioanalytical assays. Review and approve bioanalytical data and reports to ensure quality and integrity.  Ensure delivery of high-quality bioanalytical data to support immunogenicity studies and anti-drug antibody (ADA) responses. SME for immunogenicity assessment and ADA assay strategies. Stay current on the immunogenicity assessment and neutralizing ADA assay techniques.  Propose and implement new techniques as well as strategies and practices that are in line with industry practices and regulatory requirements. Develop junior scientists in scientific and professional growth.  

  Job Qualifications The following are the minimum requirements related to the Research Scientist 2, Immunogenicity role: Education: Bachelor's degree (B.S./B.A.) or equivalent in a scientific related discipline.  Related Master's degree (M.S./M.A.) or PhD/DVM preferred. Experience: Minimum of 5 years of immunogenicity assay experience in the pharmaceutical industry or CRO.   An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Certification/Licensure: None Other: Experience wiht complex biologics including multi-domains and new modalities.  Understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate.  Effective written and verbal communication skills.  Ability to handle multiple projects, prioritize work and meet deadlines.  Proficiency in the use of standard software including Microsoft Excel, Word, Powerpoint, etc. and with standard laboratory calculations.

About Safety Assessment

Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market.  Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.

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 17,000 employees within 90 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. And in 2019, revenue increased to $2.62 billion.

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 ~85% of the drugs approved by the FDA in 2019.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.

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 crrecruitment_US@crl.com. 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: Worcester

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