Primary Purpose : Develops and/or validates methodologies for various compounds and components in compliance with standard operating procedures (SOPs) and regulatory agency guidelines.

Job Duties and Responsibilities :

Organizes, conducts and evaluates analytical results and testing in compliance with applicable methods, protocols, SOPs, 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 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 Principal Analytical Investigator 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 chemist 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

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 SOPs.

Assists in evaluation of data for incorporation into written reports.

Performs other related duties as assigned.

Experience:

Bachelor's Degree 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 related Scientific field with 2+ years experience is required.

Knowledge, Skills, and Abilities:

Understands the method development and method validation process.

Performs complex analytical methods on biological matrices, often involving problem solving situations.

Experience with bottom-up protein analysis by LCMS.

Applies and interprets scientific theories, concepts, techniques, and regulatory requirements in bioanalytical and mass spectrometry studies and accepts leadership role in developing scientific approaches.

Works well in a teamwork setting, for technical direction on complex bioanalytical and mass spectrometry projects.

Tracks hours on a consistent project to project basis.

Preferred Qualifications:

Former Bioanalytical CRO experience; Customer service experience; LIMs experience: Strong written and verbal communication skills.

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).