Associate Director, Bioanalysis LCMS
- Full-time
- Permanent
For 75 years Charles River employees have worked together to assist in the discovery development and safe manufacture of new drug therapies. When you join our family you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences finance IT sales or another area your skills will play an important role in the work we return well help you build a career that you can feel passionate about.
Job Summary
TheAssociate Director of Large Molecule Bioanalysis will lead the scientific oversight of our LCMS/MSbased largemolecule bioanalytical service offering. This role requires deep expertise in mass spectrometry for proteins peptides antibody-drug conjugates and other biologics including hybrid and immunocaptureLCMS/MS approaches.
The successful candidate will be responsible for designing and validating robust bioanalytical assays to support regulated nonclinical and clinical studies (GLP/GCP). Acting as both a scientific and operational leader. The selected candidate will build laboratory capabilities oversee study execution ensure regulatory compliance and serve as the primary subject matter expert (SME) for internal stakeholders and external partners.
In this role primary responsibilities include:
- Lead the development optimization and validation of LCMS/MS methods for large molecule bioanalysis (proteins peptides antibodydrug conjugates and other biotherapeutics) in biological matrices;
- Drive the use of advanced workflows including immunocapture techniques signature peptide workflows and hybrid MS strategies;
- Prepare review and approve study schedules and draft study plans and amendments for Bioanalytical studies;
- Prepare and review toxicology study plans and amendments (sections related to the Bioanalytical analysis) in collaboration with the study director;
- Ensure that the studies are planned efficiently with regard to the experiment required staff requirements and their qualifications health and safety legislation such that the study will satisfy its objectives;
- Ensure that study personnel are fully aware of their required duties within the studies including experiment conduct data collection and integrity;
- Monitor the laboratory activities during the study by conducting regular visits to the lab by supervising critical activities and reviewing the records as appropriate;
- Supervise Bioanalytical laboratory staff in the execution of method development and transfer validation and sample analysis;
- Perform appropriate analysis and interpretation of study data generated and advise accordingly;
- Communicate appropriate information concerning studies to the sponsor study team study director Quality Assurance Program and management so that appropriate decisions and actions are carried out.
Key Elements
We are looking for the followingminimum qualifications for this role:
- Bachelors degree in Chemistry Biochemistry or related scientific field. Masters or Doctorates degree is a definite asset;
- Minimum of 10 years of relevant experience including a minimum of 7 years in a scientific position relevant to large molecule bioanalysis by LC-MS/MS;
- In-depth working experience in the development and optimization of LC-MS/MS methods for the quantification of biomolecules (proteins peptides antibodydrug conjugates) in biological matrices including hybrid workflows and immunocapture strategies;
- Excellent organizational and communication skills;
- Strong problem-solving and analytical skills;
- Ability to coach personnel;
- Experience in a Contract Research environment is an asset.
Role Specific Information:
- Location: 445 Boul. Armand-Frappier Laval QC H7V 4B3;
- Transportation: Free parking. Near the Montmorency Subway. Electric vehicle charging station;
- Annual bonus based on performance;
- Schedule: Daytime Monday to Friday;
- Permanent position as of the hiring full-time 37.5hrs per week.
Why Charles River
- We offer competitive benefits and advantages from day one to support your well-being;
- Paid development training;
- Employee and family assistance program;
- Excellent welcome program for new employees as well as in-house advancement and career development opportunities;
- Access to a doctor and various health professionals (telemedicine);
- 4 weeks Vacation & 10 Personal day policy;
- Many social activities!
If you are interested in contributing to the well-being of our communities not only across the country but around the world please join us.This is Your Moment.
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 300 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 20000 employees within 110 facilities in over 20 countries around the globe we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our clients unique challenges. Our client base includes global pharmaceutical companies biotechnology companies government agencies and hospitals and academic institutions around the world.
At Charles River we are passionate about our role in improving the quality of peoples 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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
Were committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance 401K paid time off stock purchase program Health and wellness coverage employee and family wellbeing support programs and work life balance flexibility.
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.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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 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 .
Required Experience:
Director
Key Skills
Program assessment,FDA Regulations,Manufacturing & Controls,Program Evaluation,budget forecast,Research Experience,Operations Management,Research & Development,Strategic Planning,Contract Management,Leadership Experience,negotiation
Employment Type : Full Time
Experience: years
Vacancy: 1
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