Senior Director, Product Development and Manufacturing
2 weeks ago
We are seeking a highly experienced and skilled Senior Director to lead our Combination Device Development and Manufacturing team at BlueRock Therapeutics. As a key member of our product development organization, you will be responsible for ensuring the successful development and manufacturing of our leading cell product candidates.
Key Responsibilities- Provide leadership for device development and manufacturing activities in support of our product portfolio and programs.
- Liaise with QA, RA, and program teams to ensure device development decisions consider cross-functional inputs.
- Work in close collaboration with cross-functional peers and team members to influence and define product and clinical strategy.
- Identify and assess new product and manufacturing technologies for possible integration and development.
- Act as product development subject matter expert providing advice and diligence support for company leadership.
- Take a leadership role in medical and combination device product development efforts, including customer interactions and design controls.
- Collaborate with engineers and cross-functional product development teams to develop leading-edge integrated cell therapy products.
- Ensure all development complies with relevant regulatory standards and guidance, and company product development, manufacturing, and product quality requirements.
- Bachelor's or Master's degree or equivalent, or PhD with 12+ years of experience with a minimum of ten years of medical product development and manufacturing experience.
- Experience with biologic product delivery and design controls is a strong plus.
- Thorough understanding of Design Controls and cGMP requirements compliant with ISO 13485 and the QSR (21 CFR Part 820).
- Significant experience in development and validation of medical device manufacturing processes and technologies is required.
- Demonstrated cross-functional leader with successful track record of delivering projects on time and within budget.
- Working knowledge of quality statistics is desired.
- Paid Time Off: PTO / Vacation Policy, Paid Holidays, Maternity / Paternity Leave
- Financial Benefits: 401K / Retirement Plan, Performance Bonus
- Office Perks: Free Food, Unique Office Space, Company Social Outings, Work From Home Policy
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Old Toronto, Ontario, Canada BlueRock Therapeutics Full timeJob Title: Senior Director, Device Development and ManufacturingBlueRock Therapeutics is seeking a highly experienced Senior Director to lead our Device Development and Manufacturing team. As a key member of our organization, you will be responsible for ensuring the development and manufacturing of our medical devices and combination products meet the...
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Old Toronto, Ontario, Canada BlueRock Therapeutics Full timeJob Title: Senior Director, Device Development and ManufacturingBlueRock Therapeutics is seeking a highly experienced Senior Director to lead our Device Development and Manufacturing team. As a key member of our organization, you will be responsible for ensuring the development and manufacturing of our medical devices and combination products meet the...
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Toronto, Ontario, Canada BlueRock Therapeutics Full timeJob Title: Senior Director, Device Development and ManufacturingBlueRock Therapeutics is seeking a highly experienced Senior Director to lead our Device Development and Manufacturing team. As a key member of our organization, you will be responsible for ensuring the development and manufacturing of our medical devices and combination products meet the...
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Toronto, Ontario, Canada BlueRock Therapeutics Full timeJob Title: Senior Director, Device Development and ManufacturingBlueRock Therapeutics is seeking a highly experienced Senior Director to lead our Device Development and Manufacturing team. As a key member of our organization, you will be responsible for ensuring the development and manufacturing of our medical devices and combination products meet the...
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Old Toronto, Ontario, Canada BlueRock Therapeutics Full timeAbout the RoleWe are seeking a highly experienced and skilled Senior Director to lead our Device Development and Manufacturing team at BlueRock Therapeutics. As a key member of our organization, you will be responsible for ensuring the development and manufacturing of our medical devices and combination products meet the highest standards of quality and...
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Old Toronto, Ontario, Canada BlueRock Therapeutics Full timeAbout the RoleWe are seeking a highly experienced and skilled Senior Director to lead our Device Development and Manufacturing team at BlueRock Therapeutics. As a key member of our organization, you will be responsible for ensuring the development and manufacturing of our medical devices and combination products meet the highest standards of quality and...
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Toronto, Ontario, Canada BlueRock Therapeutics Full timeAbout BlueRock TherapeuticsBlueRock Therapeutics is a leading engineered cell therapy company that utilizes its unique cell+gene platform to develop innovative cellular medicines for the treatment of neurological, cardiovascular, and immunology diseases.Job SummaryWe are seeking a highly experienced Senior Director, Device Development and Manufacturing to...
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Toronto, Ontario, Canada BlueRock Therapeutics Full timeAbout BlueRock TherapeuticsBlueRock Therapeutics is a leading engineered cell therapy company that utilizes its unique cell+gene platform to develop innovative cellular medicines for the treatment of neurological, cardiovascular, and immunology diseases.Job SummaryWe are seeking a highly experienced Senior Director, Device Development and Manufacturing to...
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Toronto, Ontario, Canada BlueRock Therapeutics Full timeAbout the RoleWe are seeking a highly experienced and skilled Senior Director to lead our Device Development and Manufacturing team at BlueRock Therapeutics. As a key member of our organization, you will be responsible for ensuring the development and manufacturing of our medical devices and combination products meet the highest standards of quality and...
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Toronto, Ontario, Canada BlueRock Therapeutics Full timeAbout the RoleWe are seeking a highly experienced and skilled Senior Director to lead our Device Development and Manufacturing team at BlueRock Therapeutics. As a key member of our organization, you will be responsible for ensuring the development and manufacturing of our medical devices and combination products meet the highest standards of quality and...
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Toronto, Ontario, Canada BlueRock Therapeutics Full timeAbout BlueRock TherapeuticsBlueRock Therapeutics is a leading engineered cell therapy company that utilizes its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology...
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Toronto, Ontario, Canada BlueRock Therapeutics Full timeAbout BlueRock TherapeuticsBlueRock Therapeutics is a leading engineered cell therapy company that utilizes its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology...
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