Senior Associate Scientist - Molecule Bioanalysis Project Scientist

Pay Competitive

Location:

Mattawan/Michigan

Employment type:

Full-Time

• Req#: 217934

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.

The Immunology and Immunochemistry disciplines support large molecule drug development using ligand binding assays, such as enzyme-linked immunosorbent assay, to measure large molecules and their immune responses. The main types of assays include Pharmacokinetic assays to measure drug and Immunogenicity assay to measure anti-drug antibodies and neutralizing antibodies. Other assay types also performed are branched DNA and cell-based assays. An array of platforms are used to support these assays that include spectrophotometer, Meso Scale Discovery, Luminex and Gyrolab.

Utilizing these platforms/assays, the teams are responsible for the method development, validation and routine sample analysis in both the regulated and non-regulated space of non-clinical and clinical studies.

Essential Functions: (The fundamental Duties & Responsibilities of the role include, but are not limited to, those listed below):

• 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 (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.
• Perform all other related duties as assigned.

Qualifications: (Knowledge, Experience,

Skills and Abilities

required to accomplish the essential functions) include but are not limited to:

• 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.
• An equivalent combination of education and experience may be accepted as a…