Method Development Scientist LBA- Senior Associate Scientist

This job is with Charles River, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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.

Job Summary

Biomarkers (and Investigative Pathology) personnel are responsible for : The development, performance, and support of biomarkers and flow cytometry-based assays. Assisting in sample analysis for both the support of internal studies as well as external client-based studies in a GLP compliant environment. Including, but not limited to cytokine, hormone, renal, cardiovascular, osteo, complement, metabolic, and inflammatory markers.

Essential Functions (The fundamental Competencies / Skills & Responsibilities of the role (products and services provided / results accomplished) include, but are not limited to, those listed :

Efficiently perform and document all procedure, materials, and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)

Actively communicate and collaborate across operational areas in order to adhere to timelines and produce quality data

Assist with the completion of laboratory investigations, assay troubleshooting, quality observations, and problem solving of technical and / or regulatory issues with oversight

Effectively develop and validate quantitative / qualitative methods / procedure with limited complexity / scope in one operational area with minimal oversight

Perform data analysis in appropriate software for at least one analytical platform with minimal oversight

Operate laboratory instruments including their respective software applications for 1-2 analytical platforms with minimal oversight

Develop critical thinking, troubleshooting and time management skills aligned with the needs of operational area

Demonstrate effective communication skills through informal discussions with peers, supervisor, and team

Develop ability to recognize method and / or data issues and communicate them to management to minimize study impact with minimal oversite

Prepare summary of method development data with minimal oversight

Write both study and non-study deviations with minimal oversite

Develop knowledge of regulatory and GXP requirements, industry standards and company SOPs within one operational area

Assist in leading the lab staff in the completion of method validation studies with oversight

Performs all other related duties as assigned

Job Qualifications

Bachelor's degree (BA / BS) with 5-7 years of relevant working experience. Master's degree (MS) with 1-2 years of relevant work experience. Doctorate degree (PhD) with no experience

Experience with micropipetting (Required)

Experience building assays, assay development (Preferred)

Elisa and Luminex experience (Preferred)

Flow Cytometry experience (Preferred)

An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above

Ability to communicate verbally and in writing at all levels inside and outside the organization

Basic familiarity with Microsoft Office Suite; Computer skills, commensurate with Essential Functions, including the ability to learn a validated system

Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and / or extra shifts; sometimes on short notice

Ability to work under specific time constraints

Salary for this role is $80k / year.

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 20,000 employees within 110 facilities in over 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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.

We're committed to providing benefits that elevate your quality of life.

Based on your position these may include :

bonus / incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

Equal Employment Opportunity

Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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.

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