Senior Associate Scientist

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.

About the role

A Research Scientist I functioning in the role of Method Developer is responsible for execution of complex method development and validation studies utilizing appropriate laboratory instrumentation and software. They perform data analysis and provide accurate summaries of method development experiments, ensuring all procedures are performed and documented in compliance with regulatory standards. The role requires understanding compliance to ensure quality data, as well as knowledge of regulatory and GxP requirements and industry standards. The Research Scientist I ensures scientific integrity of studies, meets timelines, and maintains active communication and collaboration. They recognize and communicate method and data issues, assist in laboratory investigations, and support process improvement initiatives.

Responsibilities

• Efficiently perform and document all procedures, materials, and results in compliance with applicable regulatory standards (protocols, methods, SOPs, etc.).
• Execute review and approval of data with oversight for final scientific/technical decisions within a single operational area.
• Demonstrate effective communication skills through both informal and formal discussions with peers, supervisors, teams, and across the organization.
• Actively communicate and collaborate across operational areas to adhere to timelines and produce quality data.
• Assist with laboratory investigations, assay troubleshooting, quality observations, and problem-solving of technical and/or regulatory issues with minimal oversight.
• Efficiently develop and validate quantitative/qualitative methods/procedures with increased complexity/scope in one operational area with minimal oversight.
• Independently and accurately perform data analysis in appropriate software for a majority of analytical platforms within an operational area.
• Independently and efficiently operate laboratory instruments, including their respective software applications for 1-2 analytical platforms within an operational area.
• Develop and maintain critical thinking, troubleshooting, and time management skills aligned with the needs of operational areas.
• Independently recognize method and/or data issues and communicate them to management to minimize study impact.
• Independently prepare accurate summaries of method development data.
• Independently and accurately write both study and non-study deviations.
• Develop and maintain understanding of regulatory and GxP requirements, industry standards, and company SOPs within one operational area.
• Effectively assist in leading lab staff in the completion of method validation studies as required by the operational area.
• Provide support to staff members as required by the operational area.
• Actively participate in internal process improvements, presentations, and harmonization efforts.

Requirements

• Bachelor’s degree (BA/BS) with 5-7 years of relevant working experience, or Master’s degree (MS) with 1-2 years of relevant work experience, or Doctorate degree (PhD) with no experience.
• 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 validated systems.
• Ability to work extended hours beyond normal work schedule, including evenings, weekends, extended shifts, and/or extra shifts, sometimes on short notice.
• Ability to work under specific time constraints.
• Must be authorized to work in the United States without a sponsor visa, now or in the future.

Workplace Requirements

• Perform general office and/or laboratory procedures, including talking, hearing, standing, or sitting for long periods, typing/entering data, using instruments, reaching with hands and arms, and wearing safety equipment (PPE) per OSHA regulations and company standards.
• Specific vision abilities required include close vision, color vision, depth perception, and the ability to adjust focus.
• General office working conditions; noise level is usually quiet.
• May occasionally be required to wear protective clothing (goggles, face shield, surgical mask, cap, gloves, scrubs, boots).
• May work near toxic or caustic chemicals, biohazards, and/or live animals with risk of exposure to allergens and/or zoonotic diseases.
• May occasionally be exposed to fumes, airborne particles, unpleasant odors, and/or wet, humid, or extreme temperature conditions.

Pay

$80,000 per year.

About Safety Assessment

Charles River is committed to helping 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 designs and executes 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 clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio enables our clients to create a more flexible drug development model, reducing costs, enhancing productivity, and increasing speed to market.

With over 20,000 employees within 110 facilities in over 20 countries, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving client challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies, hospitals, and academic institutions worldwide. At Charles River, we are passionate about improving the quality of people’s lives. Our mission, excellent science, and strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps improve global health and well-being. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.