Our client, a major actor in the fight against COVID-19, is looking for a Director of Manufacturing to lead their Montreal team. The Director will be responsible for the start-up of a new biomanufacturing biologics site based in Montreal. The person will recruit, manage, and develop the manufacturing team to support daily manufacturing operations of biologics and vaccines in accordance with GMP standards.
- Set up, plan, direct and leads manufacturing operations.
- Ensure that all production activities comply with GMP standards.
- Plan, prepare, and oversee end-to-end manufacturing operations ensuring the safety, quality, and compliance in the GMP operations.
- Lead the manufacturing group input for process performance qualification (PPQ) preparedness and ensure that all PPQ runs are executed to protocol requirements.
- Schedule plant activities including manufacturing, maintenance, and changeover.
- Track, trend and communicate manufacturing run data
- Alert senior managers of significant quality, compliance, supply, and safety risks.
- Ensure that risks are identified, assessed, and corrected to ensure the safety, purity, quality, and effectiveness of the product(s) manufactured.
- Identify any procedural issue including process deviations, troubleshoot issues immediately, and assist with investigation and potential corrective actions to quality incidents.
- Contribute to the development of human resources strategies and plans.
- Implement human resources plans to ensure appropriate and optimum allocation of resources to priorities.
- Bachelor of Science in Life Sciences (i.e. Microbiology, Biochemistry, Biotechnologies or equivalent).
- Significant experience in GMP pharmaceutical/biologics manufacturing.
- Experience in start-up and operation of GMP manufacturing facility and equipment
- Experience leading manufacturing teams.
- Strong understanding of GMP manufacturing.
- Capable of effective and clear communication that enables teams to execute on key deliverable.
- Bilingualism in French and English, both oral and written.
- Excellent adaptability and flexibility.
- Excellent capacity for analysis, good judgment, and critical skills
- Capacity to prioritize and execute several projects at the same time and with a minimal supervision.
- Strong leadership and team spirit
- Ability to work in a fast-paced environment.
- Effective communication skills, both verbal and written.
Please submit your resume directly to Céline Chabée at firstname.lastname@example.org, indicating “Director of Manufacturing” in the title of the email.
Only selected candidates will be contacted.