Research Scientist

About the role

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.

Responsibilities

• Perform method development, method qualification, sample analysis and other study related activities in support of bioanalytical studies
• Quality control review of bioanalytical results
• Instrument and process troubleshooting within her/his competencies
• Notify 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
• 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
• Absorb and apply 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
• Display versatility and accuracy performing laboratory operations, some of which may be difficult and/or non-routine
• Use a computer to compile and maintain databases for records and inventory, utilizing the appropriate software
• Show an attitude for quality, an eye for detail, the ability to follow written instructions and work with a minimum of supervision
• Understand GMP/GLP/GCP regulations with the ability to apply these practices daily
• Have a working knowledge and awareness of general laboratory procedures
• Be able to use personal computer and various software programs
• Have good written and oral communication skills
• Adhere to all safety regulations and procedures

Requirements

• BS or equivalent degree in Chemistry, Biochemistry, or related field, and two years qualified experience in analysis and/or bioanalysis
• MS in Chemistry, Biochemistry, or related field, and 0‑2 years qualified experience in analysis and/or bioanalysis
• Display 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
• Show versatility and accuracy performing laboratory operations, some of which may be difficult and/or non-routine
• Use a computer to compile and maintain databases for records and inventory, utilizing the appropriate software
• Show an attitude for quality, an eye for detail, the ability to follow written instructions and work with a minimum of supervision
• Understand GMP/GLP/GCP regulations with the ability to apply these practices daily
• Have a working knowledge and awareness of general laboratory procedures
• Be able to use personal computer and various software programs
• Have good written and oral communication skills
• Adhere to all safety regulations and procedures

Qualifications

• 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

Skills

• Ability to use a computer to compile and maintain databases for records and inventory, utilizing the appropriate software
• Good written and oral communication skills
• Ability to adhere to all safety regulations and procedures

Benefits

• Health and dental coverage
• Short- and long-term disability
• Paid time off
• Paid parental leave
• 401K participation with company match

Pay

Salary will be commensurate with experience and responsibilities.

Schedule

Details on schedule will be provided upon interview.