Vice President of Process Development and Manufacturing
2 weeks ago
We are seeking a highly experienced and skilled Vice President, Process Development and Manufacturing to lead our team in the development and execution of process development and manufacturing strategies for our pipeline of Bioprinted Tissue Therapeutics. This role requires a deep understanding of biopharmaceutical process development, cGMP manufacturing, and regulatory requirements associated with cell-based therapies and combination products.
Key Responsibilities- Provide strategic leadership and technical expertise in process development and manufacturing, ensuring alignment with our company's vision and regulatory requirements.
- Directly manage the Process Development and Manufacturing teams and be accountable for ongoing high-quality delivery and effectiveness of the teams.
- Forecast, schedule, and track all manufacturing activities to ensure timely disposition and accountability for Key Performance Indicators, ensuring alignment with Company objectives directly and through the management of others.
- Provide input to the overall Technical Operations strategies and operational planning.
- Lead a team of cross-functional stakeholders to drive strategic decisions into manufacturing execution.
- Spearhead the design and execution of process development and manufacturing strategies for stem cell culture, differentiation, and integration with biomaterials using our bioprinting manufacturing technology.
- Facilitate alignment with senior leadership and appropriate prioritization within manufacturing priorities.
- Liaise with various internal and external stakeholders to generate and execute preclinical and clinical project plans, including tech transfer, analytical development, process development, and manufacturing.
- Ensure efficient and compliant functioning of BTT manufacturing, including direct responsibility for biomaterial and cellular drug substances as well as BTT (i.e., drug product) manufacturing functions.
- Author, review and/or approve process development/transfer/validation study protocols and reports to ensure high-quality documentation to support regulatory filings.
- Enable and communicate a site mission and the strategic direction, business goals, objectives, and priorities.
- Foster a culture of flexibility, nimbleness, efficiency, and a strong compliance mindset while promoting positive collaboration among all team members, partners, and key stakeholders.
- Ensure processes are transferred, and products are manufactured and delivered in a safe, timely, and financially responsible manner in compliance with FDA, Health Canada, and EMA regulatory requirements.
- Analyze operating costs and drive towards efficiency improvement.
- Successfully attract, develop, and retain key talent.
- Develop and maintain departmental budget.
- Present to senior leadership and cross-functional teams across Aspect.
- Complete other duties and projects as assigned to meet company goals.
- PhD with 15+ years or MSc/BSc with 20+ years directly related experience in process development and manufacturing, with experience in cell therapy.
- Manufacturing Expert: Solid performance in managing quality events, such as deviations, CAPA, change controls. Proficient in budgeting, FTE projection, and production forecasting.
- GMP & Regulatory Knowledge: Knowledgeable about GMP requirements for biologic or cell manufacturing and have experience writing or contributing to regulatory filings.
- Beneficial Experience: Experience with scaling manufacturing processes, operations, and activities. Preferably, you also have experience working with pluripotent cells and biomaterials/bioinks.
- Knowledge: Advanced knowledge of the drug development process and the interdependencies of individual development activities and projects.
- Detail-Oriented: You have outstanding attention to detail as well as experimental and process rigor. You take pride in your work and strive for excellence.
- 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.
- Effective Communicator: You are an active listener who can communicate to different audiences in diverse situations.
- 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.
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Vancouver, British Columbia, Canada Aspect Biosystems Full time $176,000 - $271,000Job SummaryWe are seeking a highly experienced and skilled Vice President, Medicine and Quality to lead the strategy and execution of process development and manufacturing activities for our pipeline of Bioprinted Tissue Therapeutics.Key ResponsibilitiesDevelop and execute process development and manufacturing strategies for stem cell culture,...
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Vancouver, British Columbia, Canada Aspect Biosystems Full time $176,000 - $271,000Job SummaryWe are seeking a highly experienced and skilled Vice President, Medicine and Quality to lead the strategy and execution of process development and manufacturing activities for our pipeline of Bioprinted Tissue Therapeutics.Key ResponsibilitiesDevelop and execute process development and manufacturing strategies for stem cell culture,...
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Vancouver, British Columbia, Canada Aspect Biosystems Full time $176,000 - $271,000Job SummaryWe are seeking a highly experienced and skilled Vice President, Medicine and Quality to lead the strategy and execution of process development and manufacturing activities for our pipeline of Bioprinted Tissue Therapeutics.Key ResponsibilitiesDevelop and execute process development and manufacturing strategies for stem cell culture,...
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Vancouver, British Columbia, Canada Aspect Biosystems Full time $176,000 - $271,000Job SummaryWe are seeking a highly experienced and skilled Vice President, Medicine and Quality to lead the strategy and execution of process development and manufacturing activities for our pipeline of Bioprinted Tissue Therapeutics.Key ResponsibilitiesDevelop and execute process development and manufacturing strategies for stem cell culture,...
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Vancouver, British Columbia, Canada Aspect Biosystems Full time $176,000 - $271,000Job SummaryWe are seeking a highly experienced and skilled professional to lead our process development and manufacturing efforts for Bioprinted Tissue Therapeutics. As Vice President, Medicine and Quality, you will be responsible for developing and executing strategies to ensure the successful manufacturing of our pipeline products.Key...
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Vancouver, British Columbia, Canada Aspect Biosystems Full time $176,000 - $271,000Job SummaryWe are seeking a highly experienced and skilled professional to lead our process development and manufacturing efforts for Bioprinted Tissue Therapeutics. As Vice President, Medicine and Quality, you will be responsible for developing and executing strategies to ensure the successful manufacturing of our pipeline products.Key...
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Vancouver, British Columbia, Canada Aspect Biosystems Full time $176,000 - $271,000Job SummaryWe are seeking a highly experienced and skilled professional to lead our process development and manufacturing efforts for Bioprinted Tissue Therapeutics. As Vice President, Medicine and Quality, you will be responsible for developing and executing strategies to ensure the successful manufacturing of our pipeline products.Key...
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Vancouver, British Columbia, Canada Aspect Biosystems Full time $176,000 - $271,000Job SummaryWe are seeking a highly experienced and skilled professional to lead our process development and manufacturing efforts for Bioprinted Tissue Therapeutics. As Vice President, Medicine and Quality, you will be responsible for developing and executing strategies to ensure the successful manufacturing of our pipeline products.Key...
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Vancouver, British Columbia, Canada Aspect Biosystems Full time $176,000 - $271,000Job SummaryWe are seeking a highly experienced and skilled Vice President, Medicine and Quality to lead our process development and manufacturing activities for our pipeline of Bioprinted Tissue Therapeutics. This role requires a deep understanding of biopharmaceutical process development, cGMP manufacturing, and regulatory requirements associated with...
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Vancouver, British Columbia, Canada Aspect Biosystems Full time $176,000 - $271,000Job SummaryWe are seeking a highly experienced and skilled Vice President, Medicine and Quality to lead our process development and manufacturing activities for our pipeline of Bioprinted Tissue Therapeutics. This role requires a deep understanding of biopharmaceutical process development, cGMP manufacturing, and regulatory requirements associated with...
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Vancouver, British Columbia, Canada Aspect Biosystems Full time $176,000 - $271,000Job SummaryWe are seeking a highly experienced and skilled Vice President, Medicine and Quality to lead our process development and manufacturing activities for our pipeline of Bioprinted Tissue Therapeutics. This role requires a deep understanding of biopharmaceutical process development, cGMP manufacturing, and regulatory requirements associated with...
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Vancouver, British Columbia, Canada Aspect Biosystems Full time $176,000 - $271,000Job SummaryWe are seeking a highly experienced and skilled Vice President, Medicine and Quality to lead our process development and manufacturing activities for our pipeline of Bioprinted Tissue Therapeutics. This role requires a deep understanding of biopharmaceutical process development, cGMP manufacturing, and regulatory requirements associated with...
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Vancouver, British Columbia, Canada Aspect Biosystems Full time $176,000 - $271,000Job SummaryWe are seeking a highly experienced and skilled Vice President, Medicine and Quality to lead the strategy and execution of process development and manufacturing activities for our pipeline of Bioprinted Tissue Therapeutics.Key ResponsibilitiesDevelop and execute process development and manufacturing strategies for stem cell culture,...
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Vancouver, British Columbia, Canada Aspect Biosystems Full time $176,000 - $271,000Job SummaryWe are seeking a highly experienced and skilled Vice President, Medicine and Quality to lead the strategy and execution of process development and manufacturing activities for our pipeline of Bioprinted Tissue Therapeutics.Key ResponsibilitiesDevelop and execute process development and manufacturing strategies for stem cell culture,...
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Vancouver, British Columbia, Canada Aspect Biosystems Full time $176,000 - $271,000About the RoleWe are seeking a seasoned executive to lead our Process Development and Manufacturing team at Aspect Biosystems. As Vice President, Process Development and Manufacturing, you will be responsible for driving the strategy and execution of process development and manufacturing activities for our pipeline of Bioprinted Tissue Therapeutics.Key...
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Vancouver, British Columbia, Canada Aspect Biosystems Full time $176,000 - $271,000About the RoleWe are seeking a seasoned executive to lead our Process Development and Manufacturing team at Aspect Biosystems. As Vice President, Process Development and Manufacturing, you will be responsible for driving the strategy and execution of process development and manufacturing activities for our pipeline of Bioprinted Tissue Therapeutics.Key...
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