Skills & Responsibilities

• Curate and manage high performing team by executing and overseeing the training of technical staff on existing and new development methods/workflows 

• Coordinate purchasing and manage efficient use of supplies, consumables, equipment, and subcontracting of supportive analytical services 

• Implement controls and processes to proactive ensure competency of all personnel and methods are compliant with scientifically fit and appropriate to report results accurately

•  Work closely with the analytical development team to validate, tech transfer, and continuously optimize analytical methods incorporated into the analytical department

• Hands-on support of all analytical instruments, methods, and workflows during periods of high volume and serve as a companywide resource for related analytical matters

• Analyze, interpret, and release data generated in the laboratory within the organization and externally, including paying customers

• Maintain all analytical instruments to ensure continuous operation and sample throughput 

• Implement and manage compliant electronic data capturing systems such as LIMS system (e.g., Thermo Fisher Sample Manager) for high volume sample operations, data review, and release

• Ensure compliance with existing accreditations and regulatory standards, including ISO 17025, DEA, OSHA, Texas TDA, Texas DSHS, Texas DPS, and FDA

• Establish and oversee the execution of additional accreditations including ISO 17034, GLP, and CLIA by collaborating with quality assurance and subject matter experts
  Collaborate with Quality Control and R&D to support rapid product development and manufacturing through analytical testing

• Continuously optimize sample extraction techniques to support analysis

• Define and oversee a comprehensive framework to continuous evaluate workflow and scientist performance and safety in the laboratory 

• Establish laboratory operation reports ideally as a dashboard to support financial and customer management 

• Oversee and manage ongoing qualifications of existing instruments and installation qualifications of new instruments

• Prepare budgets for personnel, operations, and CAPEX for a fully functioning and ready-to-scale laboratory

• Support the commercial and operational organization through Quality of decisions and analytical integrity

• Collaborate with Quality to draft and implement technical documentation in compliance with regulatory and corporate requirements to ensure accurate time compliance, data accuracy, rapid turnaround time. Documentation includes but is not limited to SOPs, training, non-conformance/deviations, CAPAs, and risk assessments

• Work with Finance and Supply Chain to prepare and manage department budget and workforce models

Requirements

• Preferred, an advanced degree (Ph.D.) in analytical chemistry with 10+ years of industry experience in regulated analytical environments

• Doctorate Degree – 5 years of Analytical Testing and Operations Experience

• Master’s degree – 8 years of Analytical Testing and Operations Experience

• Bachelor’s degree – 10 years of Analytical Testing and Operations Experience

• Significant Experience and technical proficiency using LC-MS, LC-MS/MS GC, GC-FID, GC-MS, GC-MS/MS, and ICP-MS

• Direct experiencing validating and overseeing validation of LC and GC analytical methods following AOAC, ICH, USP, and applicable guidance 

• Managerial experience and track record of compliance in regulated testing environments; minimum of 3 years of managerial Experience directly managing people and leadership experience leading teams, allocating resources, and projects

Benefits

• Comprehensive package