Description Purpose and Scope
Provide direct supervision of a team of analysts responsible for the testing and release of TOLMAR products in support of manufacturing timelines.
Essential Duties & Responsibilities
• Supervise the testing and release of TOLMAR products, cleaning samples, raw materials, and stability samples.
• Provide assistance, training and leadership for direct reports in addition to ensuring the timely delivery of administrative tasks such as time entry and approval, resource allocation and workload balancing.
• Prioritize projects to meet timelines and prepare/oversee work schedules to ensure on-time delivery of results and establish sample priorities for reports.
• Aid in setting procedure and ensure that all operations and functions (including the laboratory) are in full FDA, cGMP compliance and staff is properly trained.
• Utilize senior analysts to assistance in laboratory investigations, projects, or advanced technical issues.
• Conduct or coordinate laboratory investigations.
• Review and approve technical reports, test methods and procedural documents and generate Certificate of Analysis, provide overall validity of the analytical results and review stability reports.
• Participate on project teams, company and department, meetings, third party audits, and regulatory audits.
• Monitor departmental spending to stay within the established budget.
• Demonstrate leadership aptitude in technical functions and people management.
• Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions.
• Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers.
• Accountable for meeting departmental and compliance timelines.
• Participates in required annual hazardous waste training. Hazardous waste involvement may include but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes, and transfer of hazardous waste between lab procedure area, satellite accumulation, and storage. Responsible for daily activities and supervising staff that are hazardous waste generators and/or handlers. Respond to spills per CP 030-0202 Chemical Spill Response.
• Perform other duties as required by business demands.
Requirements Knowledge, Skills & Abilities
• Expert knowledge in analytical testing of drug substances and formulations.
• Proficient with computer systems for sample tracking, laboratory equipment, raw data handling and storage.
• Knowledge in analytical method validation and instrument qualification.
• Thorough knowledge of government regulations of drugs and medical devices as they apply to laboratory work.
Knowledge, Skills & Abilities
• Technical leadership when working on complex problems within a technical scope in which analysis of situations or data requires an in-depth evaluation of various factors.
• Exceptional interpersonal and organizational skills that lead directly to the advancement of others and of the department as a whole.
• Ability to supervise a team of analytical professionals that is fully compliant with current Good Manufacturing Practices.
• Knowledge of analytical troubleshooting and product investigation.
• Effective oral and written communication.
• Proficient in the use of analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers.
• Ability to prepare, review, conduct and assess analytical method validations.
• Ability to coordinate activities to assure customer needs are met in terms of sample analysis cycle time.
Education & Experience
• Bachelor’s degree in Science, preferably in chemistry or biochemistry.
• Six or more year’s experience in an analytical laboratory environment with at least two years in a pharmaceutical GMP setting. Supervisory or team lead experience is preferred.
• Laboratory setting. Will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals. Standing for long periods up to 4 or more hours in a work day.
• Must be adaptable to shifting priorities and operate with a sense of urgency while maintaining high quality in order to meet important timelines in a high throughput lab.
• Business demands may present a need to work extended hours.