Biosafety Specialist

RXinsider LTD.; Michigan; Hybrid; USD 75,000 - 115,000; Full time

Benefits offered by this job

bonus/incentives based on performance

401K

paid time off

stock purchase program

Health and wellness coverage

work life balance flexibility

Job summary

Charles River is seeking a Biosafety Specialist to join the Environmental Health, Safety, & Sustainability (EHS&S) team at our Mattawan, Michigan site. You will administer biosafety and biosecurity programs, ensure regulatory compliance, and partner with operations, laboratories, and facilities to promote a strong safety culture.

Responsibilities include risk assessments, training, waste management, incident investigations, and emergency coordination.

Qualifications

• Bachelor’s degree or equivalent with 5+ years related experience, or Master’s with 1+ year related experience, in Microbiology, Biology, Biochemistry or related discipline.

Responsibilities

• Administer, maintain, and improve Biosafety, Biosecurity, and EHS&S programs to ensure regulatory compliance.
• Monitor regulatory developments and recommend program modifications.
• Maintain regulatory records, permits, registrations, reports, and documentation.
• Conduct risk assessments and provide guidance on hazards, PPE, decontamination, and exposure controls.
• Perform routine inspections, audits, and assessments of facilities and laboratories.
• Develop, coordinate, and deliver EHS&S training programs; maintain training materials and records.
• Manage hazardous, biohazardous and medical waste programs.

Skills

Biosafety

Biosecurity

Regulatory compliance

Risk assessment

Training delivery

Incident response

Education

Bachelor’s degree in Microbiology/Biology/Biochemistry

Tools

Microsoft Office

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

The Biosafety Specialist is a part of the Environmental Health, Safety, & Sustainability (EHS&S) team responsible for supporting and administering biosafety and biosecurity programs in compliance with applicable local, state, and federal regulations, as well as company policies and industry best practices. This role serves as a key partner to operational, laboratory, and support teams to promote a strong culture of safety and ensure the effective management of biological hazards across the site. In addition to biosafety and biosecurity responsibilities, the individual may support multiple programs as needed. The role is an on-site position at the Mattawan, Michigan location.

Job Description

Essential Duties and Responsibilities

• Administer, maintain, and continuously improve Biosafety, Biosecurity, and assigned EHS&S programs to ensure compliance with applicable OSHA, EPA, DOT, CDC, NIH, state, local, and other regulatory requirements.
• Monitor regulatory developments and emerging industry best practices; evaluate applicability and recommend program modifications to maintain compliance and operational excellence.
• Maintain required regulatory records, permits, registrations, reports, and documentation in accordance with company standards and regulatory requirements.
• Conduct risk assessments and provide technical guidance on biological and chemical hazards, containment practices, personal protective equipment (PPE), decontamination procedures, and exposure controls.
• Perform routine inspections, audits, and assessments of facilities, operations, and laboratories to verify compliance with applicable biosafety, biosecurity, environmental, and occupational safety requirements.
• Inspect facilities for compliance with regulations and guidelines, as applicable, and provide recommendations to management for corrective and preventive actions.
• Develop, coordinate, and deliver EHS&S training programs; maintain training materials, training matrices, and employee training records.
• Manage hazardous, biohazardous and medical waste programs, including characterization, handling, storage, transportation, manifesting, regulatory reporting, and disposal activities.
• Investigate incidents, injuries, exposures, near misses, property damage events, and safety violations; determine root causes and implement corrective and preventive actions.
• Serve as an EHS Emergency Coordinator and participate in emergency preparedness, incident response, spill response, and business continuity activities, including availability for 24-hour incident response as required.
• Serve as Co-Chair of Biosafety and Biosecurity Committee(s), providing regulatory guidance and technical expertise to employees, managers, and site leadership.
• Partner with operations, laboratory personnel, facilities, veterinary staff, and other stakeholders to ensure EHS requirements are integrated into daily operations and project planning.
• Prepare written procedures, reports, and compliance documentation for clients, auditors, and regulatory agencies; coordinate communications, inspections, and regulatory interactions.
• Promote a positive safety culture through employee engagement, coaching, and proactive hazard identification and risk reduction efforts.
• Perform other related duties and responsibilities as assigned.

Education/Experience

• Bachelor’s degree or equivalent with 5 or more years related experience, or Master’s degree with 1 or more years related experience, in Microbiology, Biology, Biochemistry or a related discipline.

Other

• Demonstrated ability to interpret/apply required federal or state regulations and manage multiple/changing priorities with many interruptions.
• Excellent commutation skills both verbal and written, project management skills, and strong time management and organizational skills are required.
• Basic familiarity with Microsoft Office Suite.
• Computer skills, commensurate with Essential Duties and Responsibilities, 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.

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
• 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.