Specialist, Manufacturing Sciences and Technology Transfer
About The Position
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 looking for a Specialist, Manufacturing Sciences and Technology Transfer who will be responsible for coordinating the implementation of new biomanufacturing projects, as well as continuous process improvement initiatives. To ensure GMP-compliant manufacturing, the Specialist will ensure the success of technology transfer and product lifecycle management, transferring product and process knowledge from customer teams to our internal teams.
Requirements
- You have a Bachelor's degree in biochemical engineering, biotechnology, bioengineering or a similar discipline.
- You have at least 3 years of experience leading technology transfers in GMP environments.
- A combination of relevant training and experience may be considered.
- You are able to communicate effectively in French and English.
- You must also have a high level of oral and written English, as you will be required to discuss complex topics with our international customers.
Responsibilities
- Lead the technical aspects of major projects and initiatives, including opportunity analysis, project definition and scope, strategy development, process mapping and optimization, as well as restructuring and change control activities.
- Provide in-depth expertise in the manufacturing of biological products derived from animal cell cultures, including upstream (USP) and downstream (DSP) processes.
- Lead the transfer of projects and the introduction of new products including finished products or components and oversee all operational aspects to ensure robust transfers in line with customer agreements.
- Evaluate and draft change requests related to products, components and processes.
- Analyze impacts, initiate changes and ensure that appropriate process controls are correctly reflected in manufacturing documentation.
- Investigate critical parameter deviations, non-compliant results and complex material issues, providing technical and scientific leadership.
- Prepare and review protocols, reports, risk assessments, technical notes and master batch records.
- Develop project plans for large-scale initiatives by applying project management tools and actively participate in achieving objectives and deliverables.
- Identify optimizations and promote continuous improvement initiatives in the execution of manufactured products.
- Collaborate with cross-functional teams to lead technical studies, facilitate technology transfer meetings, manage escalations and make strategic decisions for biologics and vaccine manufacturing processes.
- Support qualification studies, process development and implementation of systems and facilities.
- Review customer-supplied technical data sets, develop technology transfer plans and associated protocols/reports, define process-specific manufacturing equipment/materials, and ensure that appropriate process controls are correctly reflected in all manufacturing documentation.
- Provide commercial subject matter support and expertise for ongoing manufacturing activities and projects.
Benefits
- A flexible schedule and hybrid work mode.
- 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.
- Free on-site parking.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
