Scientist, Research Scientist, Clinical Research

Position: Scientist I
Primary

Purpose:

Analyze samples for various compounds and components in compliance with Standard Operating Procedures and regulatory agency guidelines.

Provides daily updates for individual analytical runs to PAI and or Management

Job Duties and Responsibilities:

Learns to conduct routine analyses in compliance with applicable methods, protocols, Standard Operating Procedures, and regulatory agency guidelines.o Prepares reagents, solutions, and QC samples as needed to complete routine assignments.

Learns how to document work and maintain study documentation and laboratory records.

Learns how to use laboratory equipment appropriate for assigned tasks.

Attends and participates in project meetings.

Learns to recognize deviations from normal results and informs Principal Analytical Investigator and/or management of any problems and/or deviations that may affect the integrity of the data.

Performs routine instrument functions for bioanalytical analysis, including accurate placement/verification of sample vials and creating accurate sequence file.

Learns to plan assigned workload on a daily basis

Learns to perform initial reviews of analytical data for acceptability of calibration, control values, chromatography, and quantitative limits. o Provides daily updates for individual analytical runs to PAI and or Management
• Contributes to a cohesive team environment. Plans individual workload in coordination with team members.

Supports process improvement initiatives.

Maintains a clean and safe laboratory work environment.

Performs other related duties as assigned.

Learns to interact with internal clients.

Working Conditions:

May work with potentially hazardous substances.

Mandatory immunizations and screening as required.

Overtime and weekend work as required.

Work requires some standing and sitting for long periods of time, including working within a laboratory hood and at standing bench top.

Work requires use of PPE (personal protective equipment).

Experience:

Bachelor's Degree in Chemistry or related Scientific field with 0-2 years experience is required (internships count)
-OR-Master's Degree or equivalent in Chemistry or related Scientific field with 0 years of experience required

Significant work experience will be considered as a substitution for education

Knowledge, Skills, and Abilities:

Familiar with the use of standard laboratory equipment.

Basic knowledge of computers and software programs.

Follow written protocols

Microsoft Office Attention to detail

Ability to prioritize and organize

Strong oral and written communication skills

Experience pipetting small volumes

Experience with analytical instrumentation

Preferred Qualifications:

Experience troubleshooting analytical methods

Knowledge of regulatory guidance for bioanalysis;
Former Bioanalytical CRO experience;

Customer service experience; LIMs experience
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