Staff Scientist

Position: Staff Scientist I
Primary

Purpose:

Develops and/or validates methodologies for various compounds and components incompliance with Standard Operating Procedures and regulatory agency guidelines.

Job Duties and Responsibilities:

• Organizes, conducts, and evaluates analytical results and testing in compliance with applicablemethods, protocols, Standard Operating Procedures, and regulatory agency guidelines.
• Maintains study documentation and laboratory records.
• Independently sets-up, maintains, operates, and performs routine and non-routine maintenance on general equipment as directed.
• Provides daily updates for individual analytical runs and project status to Principal Analytical Investigator (PAI) and/or management.
• Ensures all data meets acceptance criteria and troubleshoots failures.
• Ensures all data is analyzed, processed, and compiled in a timely manner.
• Performs peer review of data.
• Identifies and proactively addresses deviations from normal results and informs PAI and/or management of any problems and/or deviations that may affect the integrity of the data;participates in corrective action of problems.
• Promotes a cohesive team environment.
• Assists in setting up and performing method development and validation of various analytes in a variety of matrices with supervision.
• Makes suggestions for modifications in test methods or procedures.
• Provides input and participates in project meetings, plans, monitors, and guides project work.
• Ability to assist lead chemists on projects, with supervision.
• Maintains a clean and safe laboratory work environment.
• Trains and assists less experienced staff.
• Interacts with internal and external clients.
• Participates in client visits as needed.
• Assists in communicating technical information.
• Participates in process improvement initiatives.
• Effectively plans and utilizes personnel and resources for timely completion of assigned projects.
• Assists in writing reports, methods, protocols, and Standard Operating Procedures.
• Assists in evaluation of data for incorporation into written reports.
• Performs other related duties as assigned.

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 the use of PPE (personal protective equipment).

Experience:

Bachelor’s degree or equivalent in chemistry or related scientific field with 6-8+ years’ experience is required – OR – Master's degree or equivalent in chemistry or related scientific field with 5+ years’experience is required – OR – Ph.D. or equivalent in chemistry or scientific field with 2+ years’ experience is required.
*** Significant work experience will be considered as a substitution for education
*** Knowledge, Skills, and Abilities:
• Understands the method development and method validation process.
• Performs complex analytical methods on biological matrices, often involving problem solving situations.
• Applies and interprets scientific theories, concepts, techniques, and regulatory requirements inbioanalytical and mass spectrometry studies and accepts a leadership role in developingscientific approaches.
• Works in a teamwork setting for technical direction on complex bioanalytical and massspectrometry projects.
• Tracks hours on a consistent project-to-project basis.
• Strong written and verbal communication skills.

Preferred Qualifications:

• Experience troubleshooting analytical methods.
• Knowledge of regulatory guidance for bioanalysis.
• Former bioanalytical CRO experience.
• Customer service experience.
• LIMS experience.