About the position
Mirus Bio has an immediate opening for a Technical Product Engineer that will use their expertise and technical background to boost the connectivity between our Quality, Operations, Product Management, and Commercial Teams. This role will serve as the technical Subject Matter Expert (SME) for our current and future products and drive technical and operational enhancements for our product portfolio. This role interfaces directly with our manufacturing partners and test labs to drive efficiencies and oversee external production activities. This role works closely with the Director of Strategy, Product, and Business Development, Senior Quality Manager, and their teams to influence product line decisions by understanding the customer need, knowing the product manufacturing controls and limits, and driving quality assurance expectations of our products. We are currently on the lookout for a hands-on individual to join our passionate team. If you are someone who thrives in a collaborative, innovative, and fast-paced environment, join us in shaping the future of our industry and be a part of a team that continues to redefine possibilities. This role works cross-functionally with all departments within Mirus Bio and is a full-time on-site position.
Responsibilities
- Technical SME for formulation, fill, finish for our current and future products driving product and portfolio improvements for both internal operations and customer objectives and supporting both GMP and RUO portfolios.
- Drive efficiencies and oversee routine production activities at our manufacturing partners and test labs, including technical review of production batch records and associated documentation.
- Drive final product multisourcing production activities with our manufacturing partners.
- Owner of critical internal and customer facing documentation including Product Specifications, Product Regulatory Support Packets, Customer Operational/Supply Chain/QA FAQ's, Mirus Quality Supplier Survey, etc. Includes creation, maintenance, and improvements to this documentation.
- Lead operational product line management activities during the NPI processes including creation of product specifications, product item cards, product labels, and driving product portfolio consistency.
- Create connectivity between Quality, Operations, Product Management, Support and Commercial Teams by facilitating internal conversations and decisions regarding our products.
- Compile information and author comprehensive operational technical reports and presentation materials for use with internal and external stakeholders.
- Project manage and drive product process improvements using Mirus Bio's Quality Management System (QMS) including authoring change controls.
- Demonstrate behavior outlined within the Mirus Bio Employee Handbook.
- Perform other duties as assigned by Director of Operations.
Requirements
- Bachelor of Science (B.S.) degree in Biology, Engineering or related field with commensurate work experience.
- Minimum of 5 years' experience in highly technical roles focused on products and product applications such as technical support, field application specialist, technology transfer, technical writing, etc.
- 2 years' experience in the cell and gene therapy industry and/or biosciences tools industry.
Nice-to-haves
- Excellent cross-functional communicator comfortable working with all levels in an organization.
- Strong background working in a cGMP environment, navigating an ISO certified QMS, and supporting quality assurance.
- Able to effectively translate technical concepts into user-friendly content suitable for diverse audiences, including laboratory scientists, researchers, sales teams, procurement teams, and quality assurance teams.
- Prefer regulatory and/or quality assurance experience.
- PM certification or training through an accredited program is preferred.
Benefits
- We are committed to creating access and opportunities for all to develop and grow at your own pace.
- Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress.
