Life Cycle Manager, Reagents & Reagent Kits

At Nautilus, we have a big and important mission: improve the health of millions by unleashing the potential of the proteome to accelerate drug development and enable a new world of precision and personalized medicine. We are developing a single-molecule protein analysis platform of unprecedented sensitivity, scale, and ease of use that we believe will democratize access to the proteome – one of the most dynamic and valuable sources of biological insight. To accomplish this, we are pursuing hard scientific problems with an entrepreneurial mindset and creating a world-class team of builders, innovators, and dreamers across a wide range of disciplines. 
This role enables the successful and timely transition of reagent and reagent kit production into internal and external manufacturing environments.  This position works across the R&D and Operations organizations to create and implement transition plans, schedules and deliverables to bring reagents and reagent kits into commercial production. The successful candidate must be willing to be a “hands on” implementor, while having the ability to develop longer term plans and act in a cross-functional leadership role.
This position reports to the Sr. VP of Operations and is located in San Carlos, CA and requires a presence on-site.

Responsibilities

• Transition reagents and reagent kits from the R&D teams into internal and external volume production environments and processes.
• Perform and validate R&D created SOP’s and modify appropriately to meet manufacturing standards so that reagents can be successfully produced in the manufacturing environment by production technicians.
• Create BOM templates that support the commercial configurations of reagents and reagent kits. Work with the R&D teams to successfully incorporate BOM content.
• Manage and implement the documentation of all processes and formulations into the Arena PLM system. Create and implement a change control process to manage the design evolution of reagents and reagent kits.
• Work with the Development team to create qualification plans for new reagents, kits, suppliers, processes and processing equipment. Create and implement corrective actions to resolve issues that arise during the qualification process and ensure that qualification plans are completed to meet required schedules.
• Work with external CMO’s to transition new reagents and reagent kit designs into production. Ensure that CMO’s have adequate information, documentation, specifications, and inspection procedures to be successful in producing reagents and reagent kits.
• For all new reagents and processes, perform end-to-end process evaluations to determine changes/ updates that must occur throughout the production and quality inspection processes to successfully support the new reagents. Develop and implement required transition and EOL plans that meet corporate needs on commercial launch while minimizing excess, obsolete and scrap inventory.
• Participate on cross functional teams to provide Operations perspectives and support the development and launch of new reagents and reagent kits.
• Select containers and packaging that meet chemical compatibility and storage environment conditions.
• Support the design of container labeling to ensure regulatory compliance and the availability of pertinent information (part numbers, lot/batch identification, manufacturing date, expiration dates etc.).
• Interface with suppliers throughout the production supply chain to provide technical support for successfully managing supplier relationships.

Requirements

• Minimum of 10 years of experience in reagent formulation and production processes.
• Advanced degree in Chemical Engineering, Biochemistry, Biotechnology, or equivalent degree.
• Experience in reagent life cycle management and in transitioning reagent products from their prototype stage into a commercial production environment.
• Must be able to provide multiple examples of successfully transitioning a reagent product through development to commercial launch and volume manufacturing.
• Experience and the ability to provide a history of success in bringing up CMO’s to be successful at producing reagents and reagent kits.
• Knowledge of and hands-on experience in performing reagent production processes.
• Prior experience in working with DNA based materials, Antibody production, conjugation, and purification processes.
• Must be well organized and process oriented and possess excellent documentation and training skills.
• Prior experience in working with PLM systems and change control management.
• Prior experience with ISO 9001 and 13485 implementation and ongoing compliance management.
• An understanding of chemical compatibility between reagents and common packaging materials.
• Able to