Primary Purpose: Develops and/or validates methodologies for various compounds and components in
compliance with Standard Operating Procedures and regulatory agency guidelines.
Job Duties and Responsibilities:
- Organizes, conducts, and evaluates analytical results and testing in compliance with applicable
methods, 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).
Qualifications
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 in
bioanalytical and mass spectrometry studies and accepts a leadership role in developing
scientific approaches.
- Works in a teamwork setting for technical direction on complex bioanalytical and mass
spectrometry 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.