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.

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.

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

• 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.