Laboratory Director – Analytical Testing Laboratory

Pathogenia Lab; Montreal (administrative region); On-site; CAD 180,000 - 240,000; Full time

Job summary

Pathogenia Lab seeks a Laboratory Director to oversee daily GMP operations, strategic direction, and regulatory compliance in a high-performing analytical lab in Montreal. You will lead a multidisciplinary team, manage resources, and ensure high-quality data generation for pharmaceutical products, from development through post-market surveillance.

You will drive FDA/HC alignment, oversee audits and CAPAs, and mentor staff while implementing continuous improvements and adopting new analytical

Qualifications

• Ph.D. or Master’s degree in relevant field with advanced knowledge.
• Strong leadership and team management experience in a regulated lab.
• Proven regulatory knowledge and ability to manage FDA/HC inspections.

Responsibilities

• Oversee laboratory operations, testing, method development, and documentation.
• Maintain compliance with FDA, HC, and other standards including audits.
• Lead quality assurance programs and drive continuous improvement.
• Coordinate projects, budgets, and resource allocation for efficiency.
• Interact with clients and regulatory agencies, presenting results clearly.
• Mentor staff and foster a collaborative, high-performing team environment.

Skills

Leadership

Communication

Problem solving

Budgeting & resource management

Team development

Education

Ph.D. in Chemistry or Pharmaceutical Sciences

Master’s in Chemistry or Pharmaceutical Sciences

Tools

LIMS

Job description

The Laboratory Director will oversee the daily operations, strategic direction, and regulatory compliance of a high-performing GMP Certified analytical laboratory. This role requires extensive knowledge of Health Canada and FDA guidelines to ensure the laboratory's full compliance with all relevant regulatory standards. The Director will lead a multidisciplinary team of scientists and technicians, manage resources efficiently, and ensure high-quality data generation for pharmaceutical products in development, manufacturing, and post-market surveillance.

Key Responsibilities:

Laboratory Operations Management:

• Oversee all laboratory functions, including sample testing, method development, validation, stability testing, and documentation. Ensure that the laboratory meets timelines and quality expectations while adhering to established protocols.

Regulatory Compliance:

• Maintain full compliance with FDA, HC, and other relevant regulatory standards. Ensure accurate and timely preparation of regulatory submissions, audits, and documentation, including laboratory investigations, CAPAs (Corrective and Preventive Actions), and SOPs (Standard Operating Procedures).

Quality Assurance:

• Implement and monitor laboratory quality assurance programs, ensuring that all testing meets FDA and other regulatory requirements. Drive continuous improvement initiatives to enhance testing efficiency and quality.
• Lead and mentor laboratory personnel, fostering a collaborative, results-driven work environment. Provide training and development opportunities for staff in areas such as HC compliance, FDA regulations, and new analytical techniques.

Project Management:

• Coordinate and prioritize laboratory projects, ensuring the timely and successful completion of all testing requirements. Manage resources, including equipment, supplies, and personnel, to optimize workflow efficiency.

Budgeting & Resource Allocation:

• Develop and manage the laboratory budget, ensuring efficient use of resources and cost-effective operations. Identify and implement cost-saving measures without compromising quality or regulatory compliance.

Client & Stakeholder Interaction:

• Serve as the primary point of contact for clients and regulatory agencies regarding laboratory operations, data interpretation, and compliance matters. Communicate results and findings effectively to internal and external stakeholders.
• Stay up-to-date with advancements in analytical methodologies, FDA guidelines, and industry best practices. Drive the adoption of new technologies and processes to maintain the laboratory's competitive edge.

Qualifications:

Education:

• Ph.D. or Master’s degree in Chemistry, Pharmaceutical Sciences, or related field.
• Strong understanding of FDA regulations, cGMP, and ICH guidelines.

Experience:

• Minimum 10 years of experience in a pharmaceutical analytical laboratory, including at least 5 years in a leadership/management role.
• Proven track record of managing FDA inspections and maintaining FDA compliance.
• Experience with analytical methods such as PCR, HPLC, GC, ICP-MS, FTIR, UV-Vis, and dissolution testing.

Skills:

• Strong knowledge of method development and validation.
• Excellent leadership, communication, and problem-solving skills.
• Experience managing budgets, resources, and teams in a high-pressure environment.
• Familiarity with LIMS (Laboratory Information Management Systems) and other laboratory software.

Certifications:

• ASQ certification in Quality Management or equivalent is a plus.
• Strong regulatory knowledge and ability to lead laboratory operations in compliance with FDA standards.
• Demonstrated ability to manage complex projects and deliver results on time and within budget.
• Effective leadership in fostering a collaborative team environment and developing high-performing teams.
• Commitment to continuous improvement and staying current with technological and regulatory advancements.