Job Purpose

The Scientist II, New Product Development – LCMS position will work with and report to the Director Product Development, Biochemistry. This role will support LGC Clinical Diagnostics purpose of advancing the understanding of LCMS within the clinical diagnostics space. As a scientist II, this leader will work with cross functional teams to bring innovative, multiplexed LCMS quality control materials to market to serve the diagnostics community. This Scientist II will provide clearly articulated timelines and priorities and be a contributor to team’s workflow as needed to meet internal and external customer needs.

Key Responsibilities

• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals
• Technical expertise as a key scientific resource for LC-MS applications related to new product development
• Technical project leader/subject matter expert for multiple projects related to LC-MS new product development.

• Organize projects and data using Excel, Word, PowerPoint. Use specialized software as appropriate.

• Interact with clients when applicable to provide technical project updates, review and evaluate data, write reports and protocols
• Aids in coordinating all aspects of LC-MS LDT method development and validation when applicable
• Draft new product design control documentation to meet ISO13485 and applicable CE/IVD requirements.
• Ensure LC-MS equipment is monitored for appropriate operation within set parameters where applicable. Aid in new LC-MS equipment validation where applicable and aid in writing standard operating procedures (SOPs) for use and maintenance.
• Develop processes for manufacture and testing of new LC-MS products. Draft SOPs for new processes and perform method validations as appropriate.
• Evaluate alternative raw materials, develop purchasing specifications and plan for project raw material requirements by maintaining appropriate inventory of reagents.

Knowledge, Experience, and Technical Skills

• Critical thinker who can analyze data and respond quickly to manage product development projects.
• Technical capabilities with analytical expertise in LDT method development for LC-MS a plus
• Experience with LCMS-MS
• Strong knowledge of extraction techniques with biological matrices
• This position requires an individual who possesses a strong work ethic and has excellent communication, organization, and time-management skills.
• He/she must have strong computational skills, good record keeping abilities, and experience using PC based programs (MS Word, Excel, etc) as part of daily routines.
• This work demands attention to technical detail and documentation according to procedures, and the maintenance of an accurate and comprehensive laboratory notebook is required. The laboratory work requires the use of personal protective equipment and strict adherence to safety protocols, as well as regular proficiency testing and performance of shared laboratory and other duties as assigned.

Education and/or Experience

• Master’s degree in natural science with a preference for Chemistry or Biochemistry.
• A minimum of five years’ experience in technical operations or equivalent lab experience
• Experience with product/process development and manufacture in a cGMP environment.
• Familiarity with diagnostic and medical device requirements including ISO 13485.
• Strong experience in DOE (design of experiments) and Statistics are preferred.
• Experience with LC-MS required.
• Experience with LC-MS LDTs strongly preferred.
• Familiarity with LC-MS Clinical diagnostic test methods, platforms, and data analysis required.

Physical Demands

The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• May require prolonged sitting and working at a computer monitor. Repetitive motion using a keyboard or certain laboratory equipment for long periods of time. May occasionally be required to lift and move material weighing up to 30 lbs.

Work Environment

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Agreeable work environment typical of an open office setting with some exposure to noise from office machines.
• Most work is performed with biological or chemical hazardous materials in a laboratory environment.
• This position will require on site daily attendance, the hours are flexible possible 5x8hrs or 4x10hrs shifts.