We are seeking a highly motivated director or manager to lead the development of new reagents and reagent kits. The main responsibility of this position is to oversee the commercialization of new chemical and biological reagents, as well as consumable products. You will be responsible for managing, the development and production of chemical biology products for our next-generation spatial proteomics platform. You will lead internal R&D and external CDMO/CMO teams to ensure that new and existing products meet market demand.
Responsibilities:
• Lead the development of reagent products to commercialize reagent kits and consumables
• Manage teams to bring reagent and consumable products from research concepts to production and commercialization.
• Interface and coordinate with R&D and CMO/CDMO to ensure project activities can be completed on time and meet performance goals
• Drive New Product Introduction process for reagents and consumables
• Provide scientific and technical expertise to establish product specification.
• Lead the design, development, and execution of test procedures for verification and validation studies. Standardize and establish quality control assays for the consumables
• Optimize the workflow of reagents to ensure robust performance and reagent stability, while ensuring that the workflow is user-friendly for customers.
• Lead continuous improvement and sustaining efforts for products and processes in support of cost and performance objectives
• Conduct on-market product sustaining activities including troubleshooting quality issues, conducting root-cause analyses, and implementing corrective actions
• Contribute to the company's intellectual property portfolio by documenting results and filing for IP protection
• Direct the creation of comprehensive documentation, SOPs and reports for product commercialization in collaboration with internal and external resources, including engaging decision-makers and partners
Qualifications:
• MS or PhD degree in biochemistry, chemical biology, chemistry, chemical engineering, bioengineering, molecular biology or a related discipline
• Requires at least 6 years of industrial experience with demonstrated experience taking projects from early research through commercialization, preferably in the life science tool or medical device industry
• A minimum of 2 years of managerial experience is required
• Rigorous product development experience is required, particularly related to reagent development, formulation, manufacturing and packaging
• Experience with organic synthesis and/or small molecule product development is required
• Experience with antibodies and/or other affinity-based reagents is required
• Experience with functional/analytical assays to qualify and evaluate reagent performance is required
• Experience working within regulated environments (GMP, GLP, ISO, FDA, IVD, LDT, etc.) is strongly preferred.
• A high level of commitment and a track record of quality work, with attention to detail. Capable of communicating the work clearly among the team
• Hands-on experience with in situ molecular biology protocols (immunohistochemistry or FISH) and fluorescent microscopy imaging is a plus
• Keen understanding of molecular biology techniques
• Strong communication and collaborative skills, working with internal and external colleagues and regulatory disciplines.
• Strong analysis, including process statistics, and problem-solving skills to meet market needs
• Excellent organizational and time management skills
• Ability to manage progress of an unfamiliar knowledge domain
