Associate Manager / Manager – Analytical Development (AD)

About

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 Responsibilities

• Ensure analytical methods are developed and validated according to project and regulatory requirements
• Mentor 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 systems
• Drive quality and timeline objectives in collaboration with Analytical, Formulation Development, and Project Management teams
• Coordinate effectively with external laboratories, vendors, and partners to support project delivery
• Build analytical capabilities and implement best practices across projects, processes, and techniques
• Liaise with cross-functional teams to support harmonized product development timelines
• Collaborate with regulatory and R&D teams on dossier preparation
• Lead analytical activities and ensure efficient lab operations through mentorship of junior staff
• Maintain up-to-date knowledge of analytical and GMP best practices to provide technical guidance
• Participate in GMP audits of manufacturing and testing sites as an Analytical SME
• Present project updates to senior management through review meetings
• Prepare and manage project-related analytical budgets
• Support hiring and training of laboratory personnel
• Review and approve analytical documentation to ensure compliance and methodological alignment
• Contribute proactively to achieving team and organizational goals
• Participate in inspections and audits as an SME
• Oversee equipment calibration schedules and review associated records
• Train and update team members on analytical and regulatory procedures

Qualifications & Requirements

• Master’s degree (or equivalent) in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, Medical Laboratory Science, or a related field
• 10+ years of experience in a pharmaceutical R&D laboratory and/or CMO environment
• Strong experience in analytical development for solutions, semi-solids, and suspension dosage forms
• Exposure to nasal and/or inhalation products is a strong asset
• Ability to work independently and manage multiple projects with minimal supervision
• Strong communication skills (written and verbal)

Additional Information

• This 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 activities

What’s offered:

• Health and dental benefits package
• Paid vacation and sick days
• Supportive and collaborative work environment
• Opportunity to grow within a developing R&D organization