Research Scientist 2, Immunology/ Biomarkers

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.

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

BASIC SUMMARY:
In this position, individuals will serve as a Scientific team member for the Immunology and Biomarkers group in the Laboratory Sciences department. This position requires expertise in all aspects of the skills necessary to satisfy the overall responsibilities of the scientific and operational conduct of immunology (cell-based assays and flow cytometry) and biomarker (ELISA, ECL) methods development, validation, and sample analysis. The position is largely focused upon leveraging the individual's scientific strength, hands-on expertise and experience. The position will also involve mentoring junior staff and interacting with clients on a regular basis. Formal course-work or training in immunology is preferred.

Long Description

ESSENTIAL DUTIES AND RESPONSIBILITIES:

* Function independently as a Study Director in the direction and execution of assigned studies in compliance with regulations as they apply to the conduct of preclinical and clinical research. Provide scientific expertise in study conduct, design, and interpretation.
* Participate in the proposal management and bid development process, serving as a key scientific contact
for new business generated from established business relationships.

* Participate in and coordinate all phases of the study planning process with appropriate departments.
* Design preclinical assays, generate high-quality laboratory method, protocols, amendments, reports, and develop appropriate changes to study design for assigned projects and programs.
* Possess practical knowledge of relevant white papers and regulatory guidance for the conduct of biomarker and kit method developments, qualifications, and validations.
* Review, interpret, integrate, and present data on assigned studies.
* Function independently as the point of contact for the planning and execution of sponsor interaction related to assigned studies, including proposal management and study scheduling, conduct and reporting.
* Function as a subject matter expert in biomarker assays and provide scientific oversight of laboratory staff executing biomarker studies. Mentor technical staff in areas such as protocol interpretation, method development and refinement, study-related problem resolution, and technique validation.
* Provide technical and scientific guidance to the research staff.
* Attend scientific meetings, conferences, and training courses to enhance job and professional skills. Present abstracts/posters at national meetings, when appropriate, to maintain a scientific presence and visibility in areas of individual expertise.
* May supervise research and/or scientific staff, as appropriate for scope of responsibilities.
* May direct activities of assigned group(s) to ensure effective performance of function.
* Interview and select qualified exempt-level departmental personnel. Recommend, review, and approve personnel actions, including hiring, promotions and raises. Partner with Human Resources in the handling of disciplinary issues. Prepare and/or approve appropriate personnel action paperwork.
* Monitor performance of direct reports. Provide regular coaching and counseling. Prepare and deliver
salary and performance reviews; review and approve performance and salary appraisals initiated by direct reports.

* Ensure optimum performance of group function. Recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage e of opportunities, and maintain state -of-the-art practices.
* Perform testing facility management duties for the site as delegated by senior management.
* Perform all other related duties as assigned.

Job Qualifications

QUALIFICATIONS:

* 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 8 to 9 years related experience in the development and/or validation of biomarker assays is preferred (eg: ligand binding assays, enzymatic assays, Luminex, bioplex, MSD, Quanterix, ProteinSimple, flow cytometry).

* An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
* Certification/Licensure: Certification as appropriate for specialty preferred.
* Other: Full understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate. Knowledge of applicable international guidelines for all types of studies. Demonstrate leadership skills as they pertain to intra- and interdepartmental initiatives, Sponsor interactions, and business development. 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.

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 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 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.