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Head, Manufacturing Jobs
Company | Aspect Biosystems |
Address | Vancouver, British Columbia, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Transportation, Logistics, Supply Chain and Storage |
Expires | 2023-09-20 |
Posted at | 8 months ago |
We are seeking a Head of Manufacturing to lead multi-product production of investigational bioprinted tissue therapeutics (BTTs). This role oversees compliant BTT production, team training, and cross-functional solutions. Reporting to the Senior VP for Manufacturing and Process Development, you will lead internal teams and collaborates on strategic initiatives. This role ensures seamless supply of pre-clinical and BTT products and is ultimately accountable for the successful manufacturing of multiple BTT drug substances and drug products.
- Develop and maintain departmental budget.
- Forecast, schedule, and track all manufacturing activities to ensure timely disposition and accountability for Key Performance Indicators.
- Become process subject-matter expert and work with process development and manufacturing teams to ensure technical compliance and adherence is maintained
- Successfully attract, develop, and retain key talent
- Ensure efficient and compliant functioning of BTT manufacturing, including direct responsibility for drug substance and drug product manufacturing functions.
- Analyze operating costs and drive towards efficiency improvement
- Enable and communicate a site mission and the strategic direction, business goals, objectives, and priorities.
- Complete other duties and projects as assigned to meet departmental requirements
- Facilitate alignment with Aspect leadership and appropriate prioritization within manufacturing priorities.
- Present to senior leadership and cross-functional teams across Aspect
- Ensure processes are transferred, and products are manufactured and delivered in a safe, timely, and financially responsible manner in compliance with FDA, EMEA, and Rest of World (ROW) regulatory requirements
- Lead a team of cross-functional stakeholders to drive strategic decisions into manufacturing execution
- Foster a culture of flexibility, nimbleness, efficiency, and a strong compliance mindset while promoting positive collaboration among all team members, partners, and key stakeholders.
- Manufacturing Expert: Solid performance in managing quality events, such as deviations, CAPA, change controls. Proficient in budgeting, FTE projection and production forecasting.
- Education: BSc with 10+ years directly related experience in cGMP cell manufacturing environment, or combination of experience and education
- Beneficial Experience: You have experience with scaling manufacturing processes, operations, and activities. Preferably, you also have experience working with pluripotent cells and biomaterials/bioinks
- Problem Solver: You love immersing yourself in difficult technical problems and coming up with solutions that work. You think outside the box and use your experience and intuition to identify when such solutions are realistic
- GMP & Regulatory Knowledge: You are knowledgeable about GMP requirements for biologic or cell manufacturing and have experience writing or contributing to regulatory filings
- Effective Communicator: You are an active listener who can communicate to different audiences in diverse situations
- Meticulously Organized Planner: You have excellent planning and organizational skills, with the ability to balance production, development, and continuous improvement needs. You can multitask, prioritize competing deadlines, and have a track record for delivering work on time.
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