Sr. Research & Development Scientist
About The Position
The Senior R&D Scientist - Toxicology will create, develop, optimize and validate methods for clinical and forensic toxicology drug detection in various biological matrices using chromatography and non-chromatography-based technologies. Under the direction of the R&D Director and working closely with the Clinical and Regulated Laboratory Leadership, the incumbent will accomplish assigned duties with ultimate interest in providing high quality services and customer satisfaction. This position will work closely with internal colleagues to ensure the overall technical processes meets regulatory requirements, alignment with market needs and the company goals.
Requirements
- Bachelor or Master Degree in Chemistry, Biology, Toxicology or related field required.
- Bachelor’s Degree AND 6 years of experience in clinical, bioanalytical LC-MS/MS method development required, OR, Master’s Degree AND 5 years of experience in clinical, bioanalytical LC-MS/MS method development required.
Responsibilities
- Responsible for toxicology method development and method update projects and to ensure the delivery of our services meets quality standards and customer satisfaction.
- Lead collaborative toxicology method development project plans to meet expectations regarding consistent quality and workflow efficiency, including automation where applicable.
- Provide updates to the R&D Director and/or Laboratory Leadership on a regular basis with respect to project status.
- Create, develop, optimize and validate methods for analysis of drugs and metabolites in biological samples according to the company SOPs and applicable regulatory guidelines and client’s expectations.
- Proactively evaluate innovative technologies, efficiencies and solutions such as alternative sample preparation, presumptive screening, definitive testing methodologies, and automation to improve laboratory operations.
- Assist with the development and evaluation of Lean workflow processes.
- Ensure methods and processes are efficient and provide cost-effective production and scalability, and ultimately timely results to clients.
- Perform tasks assigned by the R&D Director, including bench work when necessary.
- Provide strong collaboration with Laboratory Managers, Supervisors, and Scientists providing excellent communication, flexibility, training, mentoring and oversight as they assist in the execution of specific projects. This includes providing support to Laboratory Operations for advanced LC-MS/MS troubleshooting and properly communicating actions.
- Properly and timely, develop, implement, maintain and review regularly the toxicology method SOPs.
- Ensure the toxicology methods meet the service and certification requirements of our customers and the laboratory is compliant with the Quality Control and Quality Assurance Program.
- Using the SOPs as the training guide, coordinate technical training and monitor competencies to ensure colleagues are properly trained to execute methods.
- Ensure compliance with accreditations with agencies (e.g. CAP, NYS, SAMHSA, PA), assuring ongoing compliance and successful inspection outcomes.
- Assist in implementing relevant corrective actions in response to issues identified during inspections and with unacceptable proficiency testing challenges.
- Oversee and guide safety compliance and regulations to include determining proper handling procedures of samples, cleanliness, and neatness at the workstation and within the testing facility and observance of appropriate personal protective equipment procedures.
- Perform all other duties as assigned by leadership.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
