Study Director - Bioanalytical

Study Director - Bioanalytical Req ID #:  149798 Location: 

Laval, Quebec, CA, H7V 4B3 At Charles River, we are passionate about improving the quality of people’s lives. When you join our global family, you will help create healthier lives for millions of patients and their families. 

Charles River employees are innovative thinkers, who are dedicated to continuous learning and improvement. We will empower you with the resources you need to grow and develop in your career. 

As a Charles River employee, you will be part of an industry-leading, customer-focused company at the forefront of drug development. Your skills will play a key role in bringing life-saving therapies to market faster through simpler, quicker, and more digitalized processes. Whether you are in lab operations, finance, IT, sales, or another area, when you work at Charles River, you will be the difference every day for patients across the globe.

IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly.    Job Summary Act as a Study Director/ Principal Investigator responsible for the conduct of all bioanalytical studies using LC-MS/MS, HPLC-UV or any other analytical detection method, in compliance with the Good Laboratory Practice (GLP) Regulations of the Organisation for Economic Co-operation and Development Principles and the US Food and Drug Administration (21 CFR Part 58 and subsequent amendments).

We are seeking a Study Director (Research Scientist) for the group of Bioanalytical located in Laval (greater Montreal area) in Canada.

The following are responsibilities related to the Study Director position: Act as a Study Director/Principal Investigator or Individual Scientist for all Bioanalytical studies; Prepare and review study-related documentation (e.g. draft study plans, amendments, technical procedures, etc.), in collaboration with the Study Director (as necessary); Review toxicology study plans and amendments (sections pertaining to Bioanalytical), in collaboration with the Study Director/Principal Investigator and/or Individual Scientist; Maintain compliance with general scientific/regulatory standards in the Bioanalytical laboratory; Write and review technical and scientific reports and procedures; Lead interactions with sponsors, suppliers, quality assurance auditors, regulatory auditors and Study Directors, as required; Assist with the development of techniques/assays to perform LC-MS/MS or HPLC-UV measurements of analytes in various matrices; Review analytical data generated by the services and ensure adequacy of record-keeping; Plan and coordinate the activities for validations and analysis of biological samples in a multi-disciplinary laboratory using a variety of extraction techniques, manual testing, automated equipment and analytical instruments; Ensure that study personnel are fully aware of their required duties within the studies, including experiment conduct, data collection and integrity;

The following are minimum qualifications related to the Study Director position: Bachelor's degree in Chemistry, Biochemistry or related field; Minimum 5 years of relevant bioanalytical laboratory experience, including a minimum of 3 years in a scientific position relevant to Bioanalytical or Analytical Chemistry; Minimum 3 years of relevant GLP experience; Significant experience using LC-MS/MS and HPLC-UV with chromatographic data system; Experience with instrument and software validation (21CFR Part 11); Very good knowledge and application of GLP with the ability to train technical personnel; Efficient time management; Reading and writing of English.  Bilingualism is required; Good organizational, interpersonal and communication skills; Strong troubleshooting and analytical skills.  The benefits of working for Charles River : Minimum of 3 weeks’ vacation  Paid sick / personal days   Career advancement opportunities and training  A recognition program  Positive Company Values & Culture  Tuition reimbursement program  Employee Activities  Volunteering Program (paid day)  Employee referral bonuses  Relocation assistance  Competitive benefits starting from day one (health and dental coverage)  Access to a savings and retirement program including an employer contribution  Free, unlimited, and confidential access to health care professionals for you and your family, through telemedicine app  Employee Assistance Programs 

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 

About Safety Assessment

Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market.  Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities. 

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 17,000 employees within 90 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62 billion.

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2019.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.

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