Director, Manufacturing

4 weeks ago

Montréal QC, Canada Centre de production de produits biologiques Inc Full time

The Biologics Manufacturing Center ( BMC ) Inc. is a new biomanufacturing facility created in response to the pandemic. A not-for-profit organization, the BMC aims to better meet the biopharmaceutical needs of Canadians. The BMC helps support projects of public interest, actively contributes to the overall growth and resilience of the Canadian life sciences industry and fosters industry development and innovation through Canadian production. Backed by a committed and innovative team of employees, the BMC fosters a culture of agility and transparency, with a collaborative, results-oriented approach.

Under the responsibility of the Vice-President, Operations, the **Director, Production** manages and develops the manufacturing and packaging team to ensure the excellence and success of all manufacturing activities at the BMC in accordance with Good Manufacturing Practices (GMP).

The person will work cross-functionally and act as a central pivot between quality control, quality assurance, technology transfer, facilities and engineering, as well as supply chain and warehouse, to ensure that the appropriate systems are in place to support the general GMP operation conditions.

The **Director, Production** will have the following responsibilities:
Leadership:

- Hire, develop and coach a team composed of individual contributors and supervisors by providing regular feedback, setting performance and development goals and fostering engagement.
- Communicate the vision and alignment of the organization, monitor key indicators and results, engage his/her team in achieving them and propose action plans to maximize results or mitigate obstacles.
- Provide support, technical expertise and strong leadership for his/her team which includes production supervisors, technologists and documentation specialists.
- Support with his/her leadership and expertise the people who lead projects such as facility adaptation, risk assessment, control strategy development or validation strategy.

Operational excellence:

- Manage the execution of the production plan and the direction of daily manufacturing operations to successfully complete the end-to-end manufacturing process, including media/buffer preparation, upstream, downstream and fill-finish operations.
- Optimize the capacity plan by ensuring the qualification and availability of the people required for manufacturing operations.
- Collaborate with the technology transfer teams to determine the feasibility of manufacturing and packaging processes, including process transfer and validation.

Compliance:

- Identify the gaps, deviations and issues related to manufacturing. Conduct manufacturing investigations, supporting timely closure of product impact assessment, root cause identification and CAPA.
- Review and approve technical documentation, including protocols, master batch records and reports for engineering runs, GMP campaigns and process performance qualification (PPQ).
- Ensure a presence of the production function in various committees, such as quality board, change control committee, health and safety committee, biosafety committee and other committees as needed.

Business strategy:

- Participate in the management committee and contribute to the definition of strategic objectives, key indicators and results of the organization in relation to manufacturing
- Participate in the preparation, monitoring and approval of operating and investment budgets for its function.
- Collaborate within manufacturing, cross-functionally and with senior management and external suppliers, to achieve production goals and foster continuous improvement in the areas of safety, quality and cost.

**This position matches your career aspirations. We look forward to receiving your resume if**:

- You have a BSc in life sciences (microbiology, biochemistry, etc.) and can demonstrate that you have successfully completed microbiology courses.
- You have at least 10 years of experience in the pharmaceutical industry, mainly in end-to-end production/manufacturing
- You have at least 5 years of experience in managing, mobilizing and developing teams
- You have experience in the manufacturing of biological products
- A combination of relevant education and experience may be considered.
- You are recognized for your fair and engaging leadership, your comprehensive understanding of manufacturing operations and your ability to achieve corporate goals in cohesion with other functions of the organization.
- You want to contribute to the development of a start-up organization and enjoy using your great analytical skills to navigate change and ambiguity.
- You are able to express yourself in both French and English, especially with our international customers.

**The BMC, an employer offering what's important to you**
- A flexible schedule and work hybrid work mode.
- A culture of transparency, notably with our monthly corporate meetings
- A respectful and friendly work environment
- A new building with state-o

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