Kitchener, Ontario, Canada
1 day ago
Study Director
Job Title: Study Director
Job Description

As a Study Director, you will be responsible for managing multiple in vitro assays within the Toxicology department. You will serve as the subject matter expert with respect to assay performance and life cycle management. You will work closely with the operations team to standardize assay workflows, analyze assay trends, and continuously improve assays. Additionally, you will analyze and interpret assay data and prepare client protocols and reports.

ResponsibilitiesOversee assay performance and address assay deviations from set performance indicators.Manage the life cycle of assays.Evaluate, validate, and troubleshoot methods.Maintain and update relevant Standard Operating Procedures (SOPs).Ensure assay precision, accuracy, and reproducibility through appropriate Quality Control (QC) procedures.Lead Root Cause Analysis (RCA) for deviations and repeats.Effectively communicate and coach the operations team.Contribute to the implementation of new Toxicology assays as needed.Interact with clients on technical issues.Oversee the day-to-day assay performance and ensure timely correction of any deviations.Implement, validate, and troubleshoot new High-Throughput (HTP) methods.Ensure that the scientific quality of assays is maintained during production.Follow QC procedures including charting and related measures for Statistical Process Control (SPC).Work with the operations team to determine timelines for specific projects, analyses, and method development.Process analytical data and liaise with the internal statistical department.Communicate analytical results to relevant stakeholders.Discuss technical inquiries with clients in accordance with company policy.Lead RCA investigations and ensure timely resolution identification.Perform duties of the Study Director for Good Laboratory Practice (GLP) studies, coordinating inputs from management, scientific/technical staff, and the Quality Assurance program (QS).Oversee study plan design and approval, including amendments, as well as data collection, analysis, and reporting.Prepare Study Plans/Study Protocols in consultation with the sponsor and internal management.Essential SkillsMaster's degree in Toxicology, Cell Biology, Biochemistry, or Pharmacology.Three or more years of experience in a lab testing environment.Experience in nonclinical toxicology.Experience with in vitro assays.Experience with flow cytometry.Working knowledge of Good Laboratory Practices (GLP) regulations and study management.Additional Skills & QualificationsAbility to work cooperatively in a team environment.Effective communication skills.Strong problem-solving and troubleshooting abilities.Ability to effectively prioritize and multitask.Experience conducting effective meetings.Ability to communicate effectively with staff and interface with both technical and non-technical personnel.Understanding of Quality System Procedures and Test Methods.Work Environment

This position is based in both the lab and office, requiring onsite presence with no remote work option.

Pay and Benefits

The pay range for this position is $80000.00 - $90000.00/yr.

Workplace Type

This is a fully onsite position in Kitchener,ON.

À propos d'Actalent:

Actalent est un chef de file mondial des services d’ingénierie et de sciences et des solutions de talents. Nous aidons les entreprises visionnaires à faire progresser leurs initiatives en matière d’ingénierie et de science en leur donnant accès à des experts spécialisés qui favorisent la mise à l’échelle, l’innovation et la mise en marché rapide. Avec un réseau de près de 30 000 consultants et plus de 4 500 clients aux États-Unis, au Canada, en Asie et en Europe, Actalent est au service d’un grand nombre d’entreprises du classement Fortune 500.

La diversité, l’équité et l’inclusion

Chez Actalent, la diversité et l’inclusion constituent le pont vers l’équité et la réussite de notre personnel. La diversité, l’équité et l’inclusion (DE&I) sont ancrées dans notre culture par :

L’embauche des talents diversifiés ; Le maintien d’un environnement inclusif par une autoréflexion permanente ; La mise en place d’une culture de soin, d’engagement, et de reconnaissance par des résultats concrets ; L’assurance des opportunités de croissance pour nos gens.

Actalent est un employeur souscrivant au principe de l’égalité des chances et accepte toutes les candidatures sans tenir compte de la race, du sexe, de l’âge, de la couleur, de la religion, des origines nationales, du statut d’ancien combattant, d’un handicap, de l’orientation sexuelle, de l’identité sexuelle, des renseignements génétiques ou de toute autre caractéristique protégée par la loi.

Si vous souhaitez faire une demande d’accommodement raisonnable, tel que la modification ou l’ajustement du processus de demande d’emploi ou d’entrevue à cause d’un handicap, veuillez envoyer un courriel à actalentaccommodation@actalentservices.com pour connaître d’autres options d’accommodement.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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