Job Level & compensation offered may vary depending on candidates’ experiences and competencies
Job Summary:
Analyzes biological or chemical samples and/or develops/validates methodologies for various compounds and components in compliance with appropriate standard operating procedures (SOPs) and regulatory agency guidelines.
Duties and Responsibilities:
- Organizes, conducts and evaluates analytical results and testing.
- Maintains study documentation and laboratory records.
- Independently sets-up, maintains, operates and performs routine and non-routine maintenance on general equipment, including problem identification and resolution.
- Performs quality control review of data.
- Informs Study Director, Principal Investigator and/or management of any problems and/or deviations that may affect integrity of the data; participates in corrective action of problems.
- Promotes a cohesive team environment.
- With supervisory assistance, assures technical staff compliance to SOPs and other regulatory agency guidelines.
- Assists in setting up and performing method development and validation of various analytes in a variety of matrices.
- Performs complex analyses using unfamiliar or new methods, asking for scientific guidance as needed.
- Makes suggestions for modifications in test methods or procedures.
- Provides input and participates in project meetings, plans, monitors and guides project work.
- With supervisory assistance, serves as a lead chemist on projects, overseeing a small group of technical staff.
- Trains, mentors, and assists less experienced staff.
- Maintains a clean and safe laboratory work environment.
- Participates in new equipment and instrument assessment and qualification, as appropriate.
- Participates in client visits as needed, assists in communicating technical information.
- Participates in process improvement initiatives.
- Assists in evaluation of data for incorporation into written reports.
- Effectively plans and utilizes personnel and resources for timely completion of assigned projects.
- Assists in writing reports and protocols.
- Writes SOPs and methods.
- Performs other related duties as assigned.
Education/Qualifications:
- Minimum Bachelor of Science/Arts (BS/BA) degree in chemistry or related scientific field
- Experience may be substituted for education.
- Ability to perform advanced computer skills (e.g., Word, Excel).
- 4 years related or relevant laboratory experience required with a BS/BA degree or 1 to 2 years’ experience with an MS degree.
- Experience working in GxP or regulated environment
- Familiar with the use of standard laboratory equipment (e.g., balances, pipettes, centrifuges).
- Experience with use and troubleshooting of analytical equipment.
- Effective communication (verbal and written), presentation and interpersonal skills.
- Ability to design and independently conduct tests for chemistry projects and provide initial analysis of results.
- Acts as technical resource for the department (trouble shooting, method development, qualification, maintenance and training).
- Evaluates data for incorporation into written reports.
- Advanced time management skills to complete project assignments on time, with minimal or no supervision.
- Able to effectively schedule resources.
- Understands and helps staff with compliance to SOPs and other regulatory agency guidelines.
- Identifies process improvement opportunities, recommends solutions and implements action plans.
- Able to effectively communicate, both verbally and in writing.
- Effectively interacts with internal and/or external clients.
- Acts as a project leader.
- Ability to assist in the preparation of relevant sections of final reports.
- Knowledgeable on a variety of study types, analysis procedures and methodologies
