General Fluidics is a clinical diagnostics company with a novel point-of-care instrument for simultaneous measurement of clinical chemistry, hematology and immunoassays for the veterinary medicine and human IVD markets (https://www.generalfluidics.com). We are seeking a broadly skilled Strategic Sourcing Specialist to join our fast-growing team. You will play a key role in the development and commercial launch of our next generation clinical diagnostic system.

The Strategic Sourcing Specialist will develop and manage strategic relationships with external suppliers of critical reagents and key consumable devices for our novel clinical diagnostic system (IVD). The position will work closely with internal R&D and executive management to identify external suppliers as we build manufacturing capabilities. The Strategic Sourcing Specialist will be responsible for strategic sourcing, contracting and tactical management of the entire supply chain for critical reagents and key disposable devices while optimizing internal sourcing processes, key interfaces and industry best practices expediting R&D, clinical development and manufacturing.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Lead sourcing of critical reagents/calibrators/controls and key consumable devices for development and manufacturing of our novel clinical diagnostic system (IVD).
• Drive development and implement sourcing strategies. Identify strategic suppliers and manage relationships as the primary point of contact.
• Manage the entire supply chain by describing requirements, specifications, defining analytical performance criteria, drafting requests-for-proposals, contracts, facilitating team/supplier meetings, negotiating complex terms/pricing as part of a team, and executing supplier agreements.
• Manage technology transfer, supporting documentation, change controls, timelines, risk mitigation, issue resolution, process validations (i.e., IQ/OQ/PQ’s), audits and all quality systems guidelines.
• Review and approve supplier Certificates of Analysis and internal and external testing results, assuring specification compliance.
• As part of team resolve complex manufacturing or quality assurance issues, working closely with internal/external cross-functional teams.
• Coordinate and provide subject matter expertise to deviations and investigations. Drive closure of corrective and preventive actions.
• Contribute to the establishment/management of manufacturing capabilities and clinical regulatory filings.
• Proactively support R&D, clinical development and establishment of manufacturing capabilities.
• Establish and optimize strategic supply relationships including updates, budgeting and dashboards for executive review.
• Develop a supple and flexible team which focuses on suppliers and supplier controls.

QUALIFICATIONS

• Experience managing contracts and external manufacturing partners for clinical diagnostics or life sciences.
• Experience establishing and managing vendor supply relationships against strategic plans and shifting priorities.
• Experience negotiating supply agreements and complex terms/pricing.
• Experience qualifying supply vendors and evaluating external quality assurance/stability testing.
• Solid understanding of science and technologies in clinical diagnostics or life sciences.
• Knowledge of FDA QSR regulations and guidance, quality assurance, quality control processes and good manufacturing practices across supply chains.
• Ability to influence stakeholders from many disciplines at many levels.
• Agile organizational skills against emerging priorities.
• Ability to manage ambiguity, work independently and prioritize workloads with minimal direction.
• Passion for building relationships inside and outside the company.
• Manufacturing, quality assurance and/or clinical science experience a plus.
• Knowledge of ERP systems, e-Sourcing tools, business intelligence and reporting platforms a plus.
• Knowledge of Lean Six Sigma continuous improvement a plus.

TRAVEL REQUIREMENTS:

• Some domestic/international travel for business meetings, scientific conferences and auditing.

BASIC REQUIREMENTS

• Bachelor’s degree or higher in life sciences, clinical science, supply chain/logistics, engineering or related discipline.
• 5+ years’ experience within clinical diagnostic, life sciences, biotechnology or pharmaceutical industries including supply chain management, manufacturing, contract manufacturing/research organizations, outsourcing, technology transfer, operations, quality assurance, R&D, clinical development or related disciplines.
• Desire to learn and develop novel technologies in a biotech R&D start-up.

BENEFITS

• 401(k)
• Health Insurance
• Dental/Vision Insurance
• Life Insurance
• Disability Insurance
• Paid Time Off
• Potential Annual Bonus Program
• Equity Incentives/Options