Research Analyst V, Cell & Molecular Biology

Charles River; Mattawan (MI); On-site; USD 38,000 - 54,000; Full time

Job summary

Charles River is seeking a Research Analyst IV in Michigan to execute complex routine sample analysis and method validations. The role includes leading projects, creating assay paperwork, operating laboratory instruments, and analyzing data to support validation studies.

Responsibilities also include equipment maintenance, investigations, and contributing to process improvements, with potential extended hours as needed in a regulated GLP-like setting.

Qualifications

• Bachelor’s degree (BA/BS) or equivalent experience; a minimum of 5 years of working experience in a technical laboratory role.
• Ability to work extended hours including evenings and weekends.
• Authorized to work in the United States without sponsorship now or in the future.

Responsibilities

• Execute complex routine sample analysis and method validations with oversight as a project lead.
• Create assay paperwork and operate laboratory instrumentation.
• Perform data analysis in appropriate software and maintain study inventories.
• Lead laboratory investigations and process improvement initiatives.
• Independently operate laboratory instruments and write deviations as needed.

Education

Bachelor’s degree (BA/BS) or equivalent experience

Job description

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 Overview

A Research Analyst IV within these disciplines is responsible with the execution of complex routine sample analysis and method validations primarily functioning as a project lead. They will create assay paperwork, operate laboratory instrumentation and perform data analysis within the appropriate software in support of sample analysis and method validation. They may assist with execution of method development with oversight. All procedures will be performed and documented in compliance of regulatory standards. In addition, they will perform laboratory maintenance and support functions such as equipment calibrations, monitoring expiration dates and solution preparation. They will assist with laboratory investigation and process improvement initiatives as needed.

Essential Duties And Responsibilities

• Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.).
• Effectively demonstrates the behaviors and performance characteristics as described in the CRL DNA.
• Demonstrates effective communication skills through both informal and formal discussions with peers, supervisor, team, across the organization and with Sponsors.
• Assist with and accurately perform laboratory maintenance functions as needed.
• Independently and accurately perform laboratory support functions such as labeling, monitoring expiration dates, and solution preparations as needed.
• Independently and accurately maintain study specific inventory of consumables, with increased workload Demonstrates a complete understanding of compliance and regulations by independently and accurately writing both study and non-study deviations.
• Independently identifies and leads process improvement initiatives.
• Maintain and demonstrate critical thinking, troubleshooting and time management skills aligned with needs of the operational area.
• Leads and independently /accurately executes routine sample analysis studies with increased throughput and workload.
• Leads and independently/accurately executes method validation projects with both increased throughput and workload as required by operational area.
• Independently operate all laboratory instruments.
• Independently and accurately perform data analysis in appropriate software for a majority of analytical platforms within an operational area, including completely understanding what constitutes a passing or failed run.
• Lead and independently/efficiently execute the completion of laboratory investigations, assay troubleshooting and quality observations.
• Independently and accurately prepare paperwork for routine production work.
• Independently and efficiently function as project lead for sample analysis and validation studies with increased workload and complexity as required by operational area.
• Effectively assist with training of new staff members for all functions as needed; function as a technical SME.
• Effectively perform method development as required by operational area, including creation of paperwork and data analysis, with minimal oversight of scientific staff.

Job Requirements

Minimum Qualifications

• Education: Bachelor’s degree (BA/BS) or equivalent experience. A minimum of 5 years of working experience in a technical laboratory role

Other

• 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
• Must be authorized to work in the United States without a sponsor visa, now or in the future.

Workplace Requirements

• While performing the duties of this job, the employee must be able to perform general office and/or laboratory procedures, which require, talking, hearing, standing, or sitting for long periods of time, typing/entering data into a computer, using appropriate instruments, reaching with hands and arms, and wearing safety equipment (PPE) according to OSHA regulations and company standards.
• Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.
• General office working conditions, the noise level in the work environment is usually quiet.
• While performing the duties of this job the employee may occasionally be required to wear protective clothing (goggles, face shield, surgical mask, cap, gloves, scrubs, boots), work near toxic or caustic chemicals, work with biohazards, and/or work with live animals with risk of exposure to allergens and/or zoonotic diseases.
• The employee may occasionally be exposed to fumes or airborne particles, unpleasant odors, and/or wet, humid and/or extreme temperature conditions.

Pay Rate

The pay rate for this role is $33.50/hour.

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.

For more information, please visit www.criver.com.