Large Molecule Bioanalysis- Project Scientist, Senior Associate Scientist

Charles River Laboratories • Mattawan, MI

394d • $75,000 - $75,000

About The Position

The Senior Associate Scientist in Large Molecule Bioanalysis at Charles River Laboratories is responsible for managing sample analysis projects related to large molecule drug development. This role involves executing data reviews, developing compliance understanding, and overseeing laboratory investigations. The position requires effective communication and collaboration across operational areas to ensure scientific integrity and adherence to timelines in both regulated and non-regulated studies.

Requirements

• 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, or Doctorate degree (PhD) with no experience; equivalent combinations of education and experience may be accepted.
• Ability to communicate verbally and in writing at all levels inside and outside the organization.
• Basic familiarity with Microsoft Office Suite and ability to learn a validated system.
• Ability to work extended hours beyond normal work schedule, including evenings, weekends, and extra shifts on short notice.
• Ability to work under specific time constraints.

Nice To Haves

• Experience with ligand binding assays such as ELISA, pharmacokinetic assays, and immunogenicity assays.
• Familiarity with platforms like Meso Scale Discovery, Luminex, and Gyrolab.

Responsibilities

• Manage a portfolio of sample analysis projects ensuring timelines are met.
• Review and approve data with oversight for final scientific/technical decisions.
• Develop understanding of compliance expectations to respond to quality assurance audit observations.
• Assist with oversight of laboratory investigations, assay troubleshooting, and quality observations.
• Assist in problem solving for technical and/or regulatory issues with oversight.
• Write and prepare study plans/protocols/amendments with minimal oversight.
• Participate in Sponsor visits/tours with minimal oversight.
• Develop expertise in developing and validating quantitative/qualitative methods with minimal oversight.
• Perform data analysis using appropriate software with minimal oversight.
• Develop critical thinking, troubleshooting, and time management skills aligned with operational needs.
• Demonstrate effective communication skills through informal discussions with peers and supervisors.
• Function as a liaison, maintaining timely 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.
• Communicate and collaborate across operational areas to adhere to timelines and produce quality data.
• Perform and document all procedures, materials, and results in compliance with regulatory standards.
• Write, review, and approve deviations with oversight.
• Develop knowledge of regulatory and GXP requirements within one operational area.
• Manage a small portfolio of research projects including method development and validation.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 10,001+ employees