Research Scientist
About The Position
The Research Scientist is responsible for conducting bioanalytical laboratory work, including sample preparation, LC-MS/MS analysis, data review, reporting, method development, method qualification, sample analysis and other study related activities in support of bioanalytical studies, and study support activities while ensuring compliance with SOPs, applicable regulations, and safety requirements. This role requires the Research Scientist to execute analytical procedures, manage laboratory materials, documentation, troubleshoot issues, and communicate deviations or project risks in a timely manner. Success in this role depends on delivering accurate, high-quality results while demonstrating strong organization, problem-solving, collaboration, and a proactive commitment to continuous improvement and operational efficiency.
Requirements
- BS or equivalent degree in Chemistry, Biochemistry, or related field, and two years qualified experience in analysis and/or bioanalysis or MS in Chemistry, Biochemistry, or related field, and 0‑2 years qualified experience in analysis and/or bioanalysis.
- A detailed and specific understanding of all the processes related to Bioanalysis including sample preparation, standard calibration, quality control, instrument operation and troubleshooting, advanced troubleshooting, advanced method development, data processing and reporting
- Displays versatility and accuracy performing laboratory operations, some of which may be difficult and/or non-routine.
- Ability to use a computer to compile and maintain databases for records and inventory, utilizing the appropriate software.
- An attitude for quality, an eye for detail, the ability to follow written instructions and work with a minimum of supervision.
- Understanding of GMP/GLP/GCP regulations with the ability to apply these practices daily.
- A working knowledge and awareness of general laboratory procedures.
- Ability to use personal computer and various software programs.
- Ability to work independently.
- Good written and oral communication skills.
- Ability to adhere to all safety regulations and procedures.
Responsibilities
- Perform method development, method qualification, sample analysis and other study related activities in support of bioanalytical studies
- Perform quality control review of bioanalytical results
- When needed, performing instrument and process troubleshooting within her/his competencies
- Notifying the Lab Manager and / or Principal Investigator of any deviations from the study protocol/SOPs/Best Practices or unexpected processes preventing the proper completion of bioanalysis and documented as required
- Involved in training and mentoring bioanalytical personnel
- Consulting/verifying with Principal Investigators to determine the availability of resources prior to initiation of study activities and periodically during the project as needed
- Develop a basic understanding of the drug development process and pharmacokinetic parameters
- Demonstrate an understanding of Best Practices, SOPs and Good Laboratory Practice Regulations (21 CFR, Part 58) as these relate to study-specific services provided, this job description, and general facility operations.
- Assist in training and mentoring as appropriate for new team members
- Ability to interpret analytical testing sample analysis requirements from In-life study protocol and communicate with Principal Investigator and Operations the analytical design and resources needed
- Prepare analytical reports for client studies.
- Perform all other duties and responsibilities as defined in applicable SOPs
Benefits
- health and dental coverage
- short- and long-term disability
- paid time off
- paid parental leave
- 401K participation with company match
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
