Role in a glance:
To supervise the activities of scientific and operational staff responsible for method development/validation projects and analysis of samples.
Serves as a Principal Investigator (PI) for research studies. Take on overall responsibility for the technical conduct of a study, analytical direction, review, documentation and reporting of results. All activities are conducted in compliance with appropriate SOPs and regulatory agency guidelines.
Duties and Responsibilities:
- Schedules staff and assigns resources.
- Develops appropriate training plans and ensure staff is trained.
- Assure staff compliance to SOPs and other regulatory agency guidelines.
- Act as front line contact for internal and external clients.
- As Principal Investigator (PI), take on overall responsibility for the technical conduct of a study, analytical direction, review, documentation and reporting of results.
- Organizes, conducts and evaluates analytical results and testing.
- Maintains a clean and safe laboratory work environment.
- Participates in process improvement initiatives.
- Writes, revises and reviews methods, SOPs and portions of reports and protocols.
- Effectively plans and utilizes personnel and resources for timely completion of assigned projects.
- Suggests solutions and actions to solve study problems, manages the impact on time and cost, reviews protocol changes and communicates the status of changes to the client.
- Participates in client visits.
- Assure on-time delivery of high quality data and reports.
- Assure that the final report, including any changes, is approved and in compliance with appropriate SOPs and regulatory agency guidelines.
- Acts as lead chemist with scientific experiment in support of studies.
- Acts as data approver for data generated by project team.
- Evaluates SOPs for compliance with regulator guidelines.
- Performs other related duties as assigned.
- Internal: Interacts with operational personnel, scientific personnel and department management.
- External: Contact with external clients regarding experiment design and outcome. Contacts vendors regarding troubleshooting and setup of equipment over the phone or on site.
- 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).
- BS/BA degree in science plus at least 7 years or MS degree in science plus at least 5 years of experience. Relevant experience may be substituted for education.
- Experience in PK/ADA/immonoassay/GLP
- Knowledge of appropriate regulatory agency guidelines.
- Experience with use and trouble shooting of analytical equipment is desired.
- Basic knowledge of computers and software programs.
- Familiar with the use of standard laboratory equipment.
- Demonstrates strong organizational and communication skills.
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