Toxikon is seeking a Study Director for its Analytical Chemistry department. The Study Director has overall responsibility for the technical conduct of studies according to compendia, ISO or other applicable guideline and GLP/GMP regulations. The individual represents the principal point of study control for activities related to compliance for studies.
Responsibilities include but are not limited to: protocol preparation and approval, supervision of the study, documentation of protocol deviations and amendments, reviewing data, collecting and/or approving data analysis from a variety of analytical instrumentation, ensuring accurate incorporation of results and conclusions into the study report, working with the Sponsor to address study changes, and ensuring archiving of study records. The Study Director is responsible for meeting study timelines and quality standards, and training/mentoring scientific laboratory research associates and/or other junior study directors to department or study specific SOPs and procedures. Assist in the preparation and review of SOPs and ensuring compliance with quality system requirements. Individual will support sales staff by assisting in study design and interacting with clients.
Job Duties and Responsibilities
· Reviewing protocols and data generated by the lab
· Interaction with clients, sales and other administrative functions
· Lab work
Education/Experience and Requirements
· BS, MS or Doctorate in Chemistry is required.
· Experience with USP and/or ISO testing guidelines is required.
· Extensive experience with a wide variety of analytical instrumentation, including, but not limited to, HPLC, ICP, GC/MS, & LC/MS.
· Have strong organizational skills and work ethic.
· Maintain accurate schedule and follow-up efficiently.
· The successful candidate will have at least 5 years of experience in a regulated chemistry laboratory.
· Possess excellent written and oral communication skills.
· Attain a strong knowledge of GLP regulation and work closely with regulatory affairs on interpretation issues.
· Ability to be a team player.
This position is located in Bedford, MA.
Toxikon offers a comprehensive benefits program including: paid vacation, sick and personal time, 401(k) plan with company match, medical, dental, vision care, life insurance, short and long-term disability insurances, flexible spending accounts, employee assistance program, employee referral bonus, discount programs and more.
Toxikon is an equal opportunity employer. As an equal opportunity employer we do not unlawfully discriminate against any applicant because of race, sex, gender, ethnicity, religion, creed, age, color, military/veteran status, genetic condition or information, Family and Medical Leave entitlement, sexual orientation, gender identity, national origin, ancestry, marital status, qualified physical or mental disability, transgender status, or any other legally protected class in accordance with federal, state and local laws.
Click here to apply