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Job #02677

About our client Our client is a rapidly growing pharmaceutical company headquartered in Montreal that is focused on the manufacturing and distribution of various generic brand therapeutics. The company has some of the strongest financial indicators in the industry, an experienced management team and a robust pipeline. They also offer an empowering corporate culture that is focused on the professional development and advancement of clinical team members. Position Location Associate Director, Bioanalytical Lab Montreal, Quebec Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage the bio-analytical laboratory resource, budget, and activities 2) Ensure that projects' quality and timelines are adhered to and met 3) Oversee regulatory queries relating to laboratory activities 4) Ensure compliance with regulations and SOPs 5) Provide scientific and technical leadership to the group 6) Lead a group of scientists and a group of analysts in developing/validating LC/MS/MS assays for small molecule drugs and metabolites in biological matrices along with sample analysis for clinical BE/PK studies 7) Handle overall bio-analytical laboratory staff management and performance appraisal 8) Manage all laboratory expenses and ensure that they are within the budget 9) Review and approve data and reports 10) Manage laboratory resources and schedule laboratory projects to ensure that activities meet the company priorities and timeline 11) Provide recommendations and participate in the company pipeline project selection process 12) Collaborate with other groups/suppliers to achieve continuous process improvement 13) Respond to regulatory queries related to laboratory activities/studies 14) Provide expert scientific and technical leadership to the group along with mentoring and guiding the staff 15) Operate actively in the scientific field and publish in scientific journals on a regular basis 16) Recommend and implement new technologies in the bio-analytical laboratory Requirements 1) Ph. D. with 7+ years of experience or Master's degree in Science (Analytical Chemistry or a related field) with 10+ years of experience 2) Experience in the field of bio-analytical and method development for small molecules 3) Minimum 3+ years of laboratory management and supervisory experience 4) Superb knowledge and demonstrated experience in HPLC, and LC/MS/MS 5) Excellent understanding of chemistry, chromatography, mass spectrometric principles, and related products 6) Demonstrated analytical problem identification and solving skills 7) In-depth understanding of TPD/FDA/EMEA guidelines and requirements as well as knowledge and experience of GLP regulated LC/MS/MS small molecule bioanalysis 8) Experience and excellent knowledge of dealing with regulatory agencies’ queries 9) Good team player and leader with exceptional communication, laboratory management, supervisory, and interpersonal skills 10) Superb publication/presentation record and a recognized expert in the field of bioanalysis for small molecules