Senior Associate Scientist - Flow Cytometry

Job Overview

The Immunotox group supports drug development by investigating immune responses using flow cytometry. The group supports immunophenotyping endpoints, isolation of PBMCs and cell-based stimulation assays. Utilizing these platforms/assays, the team is responsible for the method development, validation and routine sample analysis in both the regulated and non-regulated space of non-clinical studies.

• Effectively manage a portfolio of sample analysis projects while ensuring timelines are met in a single operational area with oversight
• Execute review and approval of data with oversight for final scientific/technical decisions within a single operational area
• Develop understanding of compliance expectations to respond to quality assurance audit observations in appropriate software with oversight
• Assist with oversight the completion of laboratory investigations, assay troubleshooting and quality observations
• Assist in problem solving for technical and/or regulatory issues with oversight
• Responsible for writing and preparing study plans/protocols/amendments with minimal oversight
• Participate in Sponsor visits/tours with minimal oversight
• Develop expertise in developing and validating quantitative/qualitative methods/procedures with limited complexity/scope in one operational area with minimal oversight
• Perform data analysis using appropriate software with minimal oversight
• Develop critical thinking, troubleshooting and time management skills aligned with needs of operational areas
• Demonstrate effective communication skills through informal discussions with peers, supervisor, and team;
  Function as a liaison, maintaining timely and frequent communication between CRL and Sponsor/Client/SD with minimal oversight
• Ensure scientific integrity of studies with minimal oversight
• Function as a Principal Investigator, Individual Scientist and/or Study Director as assigned with minimal oversight
• Actively communicate and collaborate across operational areas in order to adhere to timelines and produce quality data
• Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)
• Write, review and approve deviations with oversight
• Develop knowledge of regulatory and GXP requirements, industry standards and company SOPs within one operational area
• Effectively manage a small portfolio of research projects including method development and validation while ensuring timelines are met in a single operational area with oversight
• Performs all other related duties as assigned

• Bachelor’s degree (BA/BS) with 5-7 years of relevant working experience. Master’s degree (MS) with 1-2 years of relevant work experience. 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 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.

The pay rate for this role is $80k/year.

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…