Scientist II

Primary Purpose:

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

Job Duties and Responsibilities:

• Conducts 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.
• Documents work properly; maintains study documentation and laboratory records.
• Operates laboratory equipment appropriate for assigned tasks. o Learns to apply advanced technologies (mass spectrometry, robotics, and automation, etc.) as directed.
• Provides input and participates in project meetings.
• Recognizes 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.
• Plans assigned workload on a daily basis and effectively schedules multiple assignments.
• Performs initial reviews of analytical data for acceptability of calibration, control values, chromatography, and quantitative limits.
• Provides daily updates for individual analytical runs to PAI and or Management •

Learns to identify problems, determine appropriate actions, and implement solutions with support as appropriate.

• Learns to perform method validation of various analytes in a variety of matrices.
• Contributes to a cohesive team environment.
• Plans individual workload in coordination with team members.
• May train and instruct less experienced staff
• Participates in process improvement initiatives.
• Maintains a clean and safe laboratory work environment.
• Performs other related duties as assigned.
• Interacts with internal clients; may have contact with external 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 2-4+ years experience is required -OR-

Master's Degree or equivalent in Chemistry or related Scientific field with 1+ years experience is required -OR-

Ph.D. or equivalent in Chemistry or Scientific field with 0+ years experience is 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

Advanced knowledge of computers and software programs.

Can write experiment protocols

Preferred Qualifications:

Experience troubleshooting analytical methods

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

Customer service experience; LIMs experience