Senior Associate Scientist

Job Overview

Biomarkers (and Investigative Pathology) personnel are responsible for: The development, performance, and support of biomarkers and flow cytometry-based assays. Assisting in sample analysis for both the support of internal studies as well as external client-based studies in a GLP compliant environment. Including, but not limited to cytokine, hormone, renal, cardiovascular, osteo, complement, metabolic, and inflammatory markers.

Essential Functions (The fundamental Duties & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:

• 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
• Perform all other related duties as assigned

Job Requirements

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
• Biomarker experienc required.
• CRO experience preferred.
• Experience with Luminex preferred.
• 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.

Physical Demands:

• While performing the duties of this job, the employee must be able to perform general office and /or laboratory procedures, which require, talking, hearing, standing, or sitting for long periods of time, typing/entering data into a computer, using appropriate instruments, reaching with hands and arms, and wearing safety equipment (PPE) according to OSHA regulations and company standards.
• Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.

Work Environment:

• General office working conditions, the noise level in the work environment is usually quiet.
• While performing the duties of this job the employee may occasionally be required to wear protective clothing (goggles, face shield, surgical mask, cap, scrubs, boots), work near toxic or caustic chemicals, work with biohazards, and/or work with live animals with risk of exposure to allergens and/or zoonotic diseases.
• The employee may occasionally be exposed to fumes or airborne particles, unpleasant odors, and/or wet, humid and/or extreme temperature conditions.

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