ESSENTIAL PRODUCT TRANSFER FUNCTIONS:

• Responsible for supporting the transfer and validation of molecular diagnostic assays, assay formulations, QC methods, and testing processes into manufacturing
• Drafts finalized transfer documents containing key manufacturing and QC processes for successful transfer of Molecular Diagnostic Assays to Operations Manufacturing and Operations QC
• Responsible for development of QC test methods and Gold Stocks for final release of raw materials, sub-assemblies, and final molecular diagnostic products
• Responsible for analyses of complex QC development data to establish QC acceptance criteria for final release of product
• Supports stability studies and quality testing plan for raw materials and/or formulations required for newly developed products, ensuring robust performance
• Supports investigations and studies of current molecular diagnostic products for continuous improvement initiatives

ESSENTIAL SENIOR SCIENTIST FUNCTIONS:

• Acts as a liaison between the company and technical partners that may be established to enhance the results of the research/development projects underway
• Conducts complex experimentation including data collection, summary, and thorough analysis, in support of department research projects and guidelines. Compose robust experimentation strategies that maximize effective use of resources and time to deliver optimal information
• Analyzes complex data sets, with understanding of relevant statistical analyses and can present findings to various audiences
• Participates as an integral member of the scientific staff in formulating research strategy and methodology
• Provides recommendations and observations to scientific staff and management on results of projects/tasks. Plays a key role in the formulation of research strategies and tactics.
• Is innovative with respect to research methods and product formulation to resolve problems and accomplish company objectives. Pro-actively recommends strategy to overcome hurdles.
• Maintains records of laboratory activities and notebooks in a professional, accurate manner. May provide support to regulatory and intellectual property activities.
• Operates complex laboratory equipment, routine maintenance, and coordinates calibration and repairs. Interfaces with contracted repair technicians as required
• Understands theoretical basis for analytical instrumentation
• Operates equipment and conducts tasks in a safe manner, adhering to established guidelines and applicable regulations
• Plans, coordinates, trains, and directs the tasks of junior staff assigned to their development projects
• Possesses strong technical writing skills to generate verbal and written reports as necessary and to summarize laboratory activities and projects. Initiates communication with related staff and functions as necessary to coordinate activities effectively.
• Contributes scientific leadership and innovation increasingly independent of external direction
• Assists in the professional and scientific development of junior staff members
• May represent department and/or company to outside organizations and companies, in conjunction with management
• Carries out duties in compliance with established business policies

Education and Experience

• BA/BS in life sciences, similar field or equivalent and 9-11 years of related experience, or MA/MS in life sciences, similar field or equivalent and at least 8 years of related experience, or PhD in life sciences, similar field, or equivalent and 5-8 years of related experience
• Product Transfer Skills/Knowledge. Biochemical – knowledge and hands-on experience with mathematical calculations pertaining to chemical formulations, enzyme activity assays, and a thorough understanding of current molecular biology techniques, especially qPCR.
• Experience with evaluating and transferring injection molded components and other plastics/consumables into a manufacturing environment desirable.
• Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.
• Experience with process and product validations, specification setting, and test method validations, and FDA design control documentation is preferred/a plus.