Our client, a pharmaceutical company with a strong focus on R&D and product development, is looking for an Associate Manager / Manager Analytical Development (AD) to join its R&D team in Concord, Canada.This is a key managerial role within the organization, responsible for overseeing GMP analytical activities for assigned projects and ensuring their timely execution in line with scientific and regulatory requirements. The successful candidate will independently manage the functioning of the Analytical GMP laboratory, lead analytical initiatives, and ensure compliance with timelines, quality standards, and regulatory expectations. This role reports to the Senior Manager, R&D.Key ResponsibilitiesEnsure analytical methods are developed and validated according to project and regulatory requirementsMentor laboratory personnel in analytical testing, reporting, and documentation to support regulatory submissions and technology transfer to Contract Manufacturing Organizations (CMOs)Ensure methods meet international regulatory standards and align with internal analytical and quality systemsDrive quality and timeline objectives in collaboration with Analytical, Formulation Development, and Project Management teamsCoordinate effectively with external laboratories, vendors, and partners to support project deliveryBuild analytical capabilities and implement best practices across projects, processes, and techniquesLiaise with cross-functional teams to support harmonized product development timelinesCollaborate with regulatory and R&D teams on dossier preparationLead analytical activities and ensure efficient lab operations through mentorship of junior staffMaintain up-to-date knowledge of analytical and GMP best practices to provide technical guidanceParticipate in GMP audits of manufacturing and testing sites as an Analytical SMEPresent project updates to senior management through review meetingsPrepare and manage project-related analytical budgetsSupport hiring and training of laboratory personnelReview and approve analytical documentation to ensure compliance and methodological alignmentContribute proactively to achieving team and organizational goalsParticipate in inspections and audits as an SMEOversee equipment calibration schedules and review associated recordsTrain and update team members on analytical and regulatory proceduresQualifications & RequirementsMasters degree (or equivalent) in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, Medical Laboratory Science, or a related field10+ years of experience in a pharmaceutical R&D laboratory and/or CMO environmentStrong experience in analytical development for solutions, semi-solids, and suspension dosage formsExposure to nasal and/or inhalation products is a strong assetAbility to work independently and manage multiple projects with minimal supervisionStrong communication skills (written and verbal)Additional InformationThis role may require occasional work on an afternoon shift (12:00 PM 8:00 PM)Travel within Canada and internationally may be required for technology transfer activitiesWhats offered:Health and dental benefits packagePaid vacation and sick daysSupportive and collaborative work environmentOpportunity to grow within a developing R&D organization
Job Title
Manager Analytical Development