Specialist/Sr. Specialist, Toxicology
Horsham, PA, US, 19044
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
The Specialist/Sr. Specialist supports departmental operations by contributing to effective communication across scientific and operational teams to support workflow and study execution. The role involves participating in efforts to enhance and/or implement procedures and support training initiatives as needed. Additionally, this individual plays a role in identifying scientific operational needs and supporting science-based projects that contribute to quality, efficiency, and overall team success.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Provides guidance/consultation on conduct and oversight of nonclinical studies and support functions that directly impact the quality, success, and growth of site-level toxicological operations.
• Interacts with research support and technical groups (i.e., technical operations, laboratories) and shares suggestions for improving or optimizing processes and procedures.
• Performs or assists departmental leadership in:
o Risk-based assessment by identifying potential problems that may impact successful conduct of nonclinical programs and propose and implement effective solutions to resolve;
o Ensuring consistent study oversight of critical study activities;
o Ensuring timely completion and documentation of departmental, site-level, or global training;
o Resolving internal and external customer requests, inquiries, and complaints that directly impact the business;
o Promoting and supporting integration and harmonization of initiatives/activities implemented within the site or organization; and
o Creating educational resources to support learning and process improvement, scheduling and co-leading training.
• Functions as departmental representative for interdepartmental communications and initiatives as required.
o Liaises with scientific staff and operational teams to identify best practices for communication, workflow, and quality improvement.
o Interacts with Operational Management and Scientific Directors across site to contribute to developments and help ensure cohesive interdepartmental and/or cross-site interactions. Fosters effective communication between the assigned departments.
o Serves as a representative to support SOP/BOP review and provides guidance as required for changes, refinements and updates to current procedures.
• May drives quality improvement initiatives through creating educational resources to support learning and process improvement, scheduling and leading/co-leading training, collecting feedback, and performing periodic effectiveness checks.
• Provides support for scientific and/or site level projects through in-depth process review and needs assessment. Focuses on business performance that eliminates waste, improve customer experience, and increase quality.
• Supports departmental leadership in ensuring departmental policies, practices and procedures adhere to regulatory, safety, and Animal Welfare guidelines and requirements applicable to the conduct of safety assessment studies.
• Performs all other related duties as assigned.
Job Qualifications
• Education: Bachelor’s (BA/BSc) plus relevant experience or Master’s (MA/MSc) or equivalent in Toxicology, Pharmacology, Biomedical Research, or a related discipline.
• Experience: Specialist: 9-12 years of contract lab or scientific monitoring experience; Sr. Specialist: minimum of 12+ years of contract laboratory (operational and/or scientific) or scientific monitoring experience.
• Certification/Licensure: DABT optional
• Other: Must demonstrate autonomy, strong collaborative skills for in-person and remote teams, excellent communication (both written and verbal) and organizational skills, adaptability, strong critical thinking, decision-making and change management skills, proven track record of accomplishments demonstrating process development or project ownership, and the ability to meet internal and external deadlines. Effective facilitation and negotiation skills. Ability to interact appropriately with all levels of employees and cross-site teams.
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.
Nearest Major Market: Philadelphia
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