Production Manager
2 months ago
**About**:
In this leadership role, the Production Manager will be responsible for establishing and leading the manufacturing operations at Vital’s Mississauga site. Working collaboratively with our Engineering, Consumable and Assay teams, as well as the rest of the Manufacturing Operations team, you will drive the build-out and scale-up of manufacturing activities for consumable assemblies and reagents including lyosphere fabrication as well as establishing manufacturing procedures and controls including batch records and inventory management. Duties include managing technical manufacturing staff, creating, reviewing and approving cGMP procedures as well as manufacturing work instructions, supporting the development and execution of validation protocols and reports, developing and maintaining annual budgets and production schedules as well as managing the maintenance and calibration of equipment used in manufacturing.
**What you'll do**:
- Provide leadership for the Manufacturing Production functions, including hiring, mentoring, and developing staff members;
- Ensure that projects are appropriately defined and staffed with personnel and resources;
- Develop and oversee the successful execution of weekly and monthly production activities for prototypes and through to production scale-up;
- Interface with Research, Process Development, Assay Development, Consumable and Engineering teams to oversee the transfer of manufacturing processes and technologies into a cGMP environment
- Work with the rest of the manufacturing operations team in the identification of technical and schedule risks, identify and implement effective countermeasures to reduce the probability and impact;
- Establish appropriate manufacturing processes and controls to create and maintain consistency and quality of production from prototype through production scale-up;
- Drive continuous improvement in the manufacturing production activities by identifying tools, fixtures and process improvements and working with Manufacturing Engineers to implement
- Manage and oversee the successful development, approval, and management of cGMP manufacturing documentation and respective computerized information systems;
- Identify space and equipment requirements and capital requirements for production and work with executive leadership and other functional leaders to develop appropriate plans and timelines for implementation;
- Responsible for documentation review to ensure compliance with ISO13485, 21CFR820, or MDSAP requirements;
- Provide oversight into investigations of CAPA actions related to manufactured products and manufacturing processes;
- Provide day-to-day leadership, clear direction, guidance, and performance feedback to direct reports; with a focus on developing and coaching the team.
**What you need**:
- Bachelor’s Degree in STEM;
- 10+ years of industry experience with specialized knowledge and experience in cGMP manufacturing in the IVD space with emphasis on consumable assembly and reagent manufacturing;
- Familiar with global IVD regulations related to the manufacture of instruments, reagents, and consumables for IVDs, validation/qualification requirements, and record-keeping is preferred;
- Excellent communication skills and attention to detail;
- Strong organizational skills and ability to multitask across projects and activities;
- Proven ability to build effective teams and participate in multi-disciplinary teams.
**Bonus points for**:
- Prior experience with high volume consumable assembly and automation would be welcomed;
- An appreciation of puns
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