Job Description

Job Summary:

Historically based in Rochester, NY, the Global Quality Technical group is a function of the process R&D organization. The group primarily supports the global commercialization and qualification of products, processes, sites, and methods from early stage R&D through plant manufacturing and customer utilization. As a whole, the Global Quality Technical group collaborates with R&D, Manufacturing, Regulatory, and Global QA for the Health & Biosciences Businesses to lead, guide, and transfer quality best practices. The group consists of 4 key areas of scientific expertise and provides comprehensive services in Microbiology and Molecular, Culture Collection, and Bioanalytical. In 2025, the Global Quality Technical groups and laboratories will be re-locating to Wilmington, DE to be integrally connected within the H&B organization.

Travel is required most frequently to the Rochester, NY facility for training and transition purposes within the first year of relocating the Global Quality Technical Group to Wilmington, DE. This role will be central to the relocation efforts.

Functional Overview:

The Microbiology Team is responsible for services and transfer activities, qualification, and scientific solutions utilizing traditional microbiological and molecular methods and tools to support suitable, reliable, compliant, and repeatable FPFQ. Areas include pathogen and enumeration, confirmation and identification, rapid method, traditional PCR, qPCR, dPCR, MALDI biotyper, and the development and application of new technology.

Role Specific Overview:

This position serves as the technical and operational leader of the functional discipline. Distribution of responsibilities roughly 10% creation, 20% innovation and new technology, 20% customer intimacy and technical partnership, and 50% leadership.

Job Specific Requirements

• Oversight for knowledge, understanding, creation, execution and maintenance of standard operating procedures. Ensures appropriate training on methods and that results are validated against standards as appropriate.
• Supports Team analyses, identification and qualification of target analytes as well as reporting results to respective customers and stakeholders.
• Works directly with Team, suppliers, and other departments to determine the root cause of any deviation in analysis protocols or results. Ensures corrective actions are put in place to prevent future/repeat occurrences.
• Oversight for research, validation, and implementation of methods, including purchasing of any required equipment through CAPEX and installation, commissioning and onboarding of the equipment.
• Innovates creative solutions to address commercialization and business needs in a timely and effective manner.
• Leadership for H&B functional support across the process of commercialization with defined cross-functional teams and partners.
• Key collaborator and consultant to ensure project, product, process, and compliance requirements are achieved.
• Key interface with Plant QAQC, R&D, Plant Technology and Ops, Product Stewardship and Regulatory, H&B Quality Assurance, and external labs, customers and vendors.
• Strengthens collaboration with relevant business counterparts, leverages first-hand knowledge of the marketplace and applies application expertise to deliver solutions.
• Able to motivate and develop a high-performing Team with strong communication, mentorship, coaching and conflict management.
• Assures lab is operating to maintain a conscientious budget and drives opportunities for continuous improvement in an operational, procedural, and functional capacity.
• Effective computer, data interpretation, and database management skills (LIMS, SAP, SharePoint, Office 365 (Excel expertise a plus), Microsoft Teams, Microsoft Access).
• Strong ability to work under pressure and adapt easily to rapidly changing needs and priorities.
• Strong ethics and integrity.
• Able to work on-site every day for the full day. This is not a remote position
• Bachelor's Degree in relevant discipline
• 10+ years of relevant experience, including education

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