Director, Manufacturing Sciences and Technology Transfer

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, result-oriented approach.

We are seeking a **Director, Manufacturing Sciences and Technology Transfer (MSAT)** who will be responsible for developing and implementing biologics manufacturing and technology transfer strategies to achieve organizational objectives. The individual will lead departmental activities, manufacturing projects and continuous improvement initiatives, ensuring regulatory compliance. This key role in the success of the CPPB's mandates will oversee the success of product lifecycle management and process validation through scientific, technical and operational expertise.

The **Director, Manufacturing Sciences and Technology Transfer** will have the following responsibilities:

- Manage the Manufacturing Sciences and Technology Transfer function (define objectives, manage budget and expenses, ensure resource development, etc.).
- Lead, supervise and mobilize a team of 3 to 5 specialists.
- Ensure robust technology transfers by leading all operational aspects involved in technology transfer from a product sponsor to the BMC; and from the BMC to commercial contract manufacturing organizations (CMOs) where applicable.
- Review customer-supplied technical data sets and develop the technology transfer plan, as well as supporting associated protocols/reports, defining process-specific manufacturing equipment/materials, and ensuring that appropriate process controls are accurately reflected in all manufacturing documentation.
- Collaborate with cross-functional project teams, sponsor strategic initiatives, coordinate technical studies, manage technology transfer related meetings, escalate and drive decision making on technology transfer strategies.
- Proactively develop risk mitigation plans throughout the technology transfer project lifecycle.
- Supervise the validation of manufacturing and cleaning products and processes.
- Provide technical leadership during manufacturing investigations.
- Evaluate and draft, when required, change requests related to products, components and processes, while analyzing impacts and ensuring that appropriate process controls are properly reflected in manufacturing documentation.
- Support the corporate development team on product and process technical issues.
- Manage the writing of Batch Records, responsible for internal approval and management of customer approval.
- Provide technical assistance and leadership for clinical and/or commercial technology transfer and qualification studies associated with the implementation of processes, systems and facilities related to biological products, vaccine drug substances and key intermediates, e.g. process intermediates, buffers and media.
- Maintain up-to-date regulatory knowledge in biopharmaceutical, sterile and related sectors.
- Improve manufacturing and cleaning processes to meet customer needs, improve performance and quality, while minimizing costs.

**This role matches your career aspirations? We want to receive your resume if**:

- You have a minimum of a Bachelor's degree in bioengineering, chemical engineering or biochemical engineering.
- You have a minimum of seven (7) years of experience in GMP manufacturing of sterile, vaccines or biological products.
- You have minimum of five (5) years of people management experience.
- You have a minimum of five (5) years of practical tech transfer experience.
- You have a minimum of two (2) years' experience working for a CMO or a CDMO.
- A combination of relevant education and experience may be considered.
- You are fluent in French.

**The BMC, an employer offering what's important to you**
- A flexible schedule and telework
- A culture of transparency, notably with our monthly corporate meetings
- A respectful and friendly work environment
- A new building with state-of-the-art equipment
- A competitive salary commensurate with your skills
- An attractive vacation and leave program
- A group RRSP with a generous contribution from the BMC
- A comprehensive insurance plan including telemedicine
- An opportunity to participate in our various life committees (social club, employee committee, OHS committee, etc.)
- A host of activities throughout the year to socialize with your colleagues, recognize team successes and improve your knowledge.

**The BMC, an organization like no other**
- Our team is made up of talented, committed individuals with diverse backgrounds.
- We aim to develop, share and tran