The Technical Director - 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. Working closely with the Clinical and Regulated Laboratory Leadership to 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.
Lead toxicology method development and method update projects and to ensure the delivery of our services meets quality standards and customer satisfaction.
Direct, manage and lead collaborative toxicology method development project plans to meet expectations regarding consistent quality, workflow efficiency including automation where applicable. Develop project budgets identifying appropriate resources, timelines and cost. Update the Toxicology Development Leadership Team 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.
Working closely with clinical and regulated laboratory operations to ensure proper LCMS preventive maintenance program is executed correctly which may include training of Scientists and be accountable for review/approval of all service maintenance.
Maintain and develop when necessary Metrics to accurately determine laboratory operations including but not limited to instrument up-time, diagnosis of instrument issues, instrument capacity and cost per test.
Work closely with Quality and IT Departments to ensure IT processes provide functionality to Laboratory Operations to enhance services. Inclusive in this duty is assistance to upgrade new software versions, and leading implementation of LIMS functionality.
Oversee the tasks assigned to the Toxicology Method Development team and be ready, willing and able to be on the bench when necessary. Provide strong collaboration with Laboratory Managers, Supervisors, and Scientists providing excellent communication, flexibility, training, respect, 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.
Responsible for 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.
Drugscan offers a comprehensive employee benefit program including health insurance (medical, dental, vision and prescription drug), medical and dependent care, flexible spending accounts, life insurance, disability, paid time off and 401(k). DSI Medical is an Equal Opportunity/Affirmative Action Employer.
Ph.D. in Chemistry, Biology, Toxicology or related field required.
2 years of experience in clinical, bioanalytical LC-MS/MS method development required.
Employer will assist with relocation costs.
Internal Number: N/A
About Drugscan / ACM Global Laboratories
Drugscan is a national toxicology and infectious disease testing laboratory that partners with organizations and providers for healthier lives and safer workplaces. With over 35 years of experience in toxicology testing via their CAP and SAMSHA certified laboratory, Drugscan provides prescription drug and addiction monitoring, specialized drug testing, and workplace drug testing, screening and program management services to clients in 48 states. DrugScan also provides infectious disease testing services, including real-time PCR testing for COVID-19, through their ViraScan laboratory.