Bioanalytical Lab Manager

The Position

Initially, the Lab Manager will assist in the set up and implementation of a GLP lab. Once the GLP lab is established, the Lab Manager will lead a team of scientists in regulated method validation and sample analysis in support of GLP toxicokinetic and GCP pharmacokinetic studies. The lab manager will have expertise with LC-MS and HPLC-FL analytical platforms and is well versed in regulated bioanalysis. The lab manager will establish and lead bioanalytical training and provide expertise to less experienced scientists. The lab manager will be joining a team of highly motivated and experienced scientists and will contribute to the success of Arrowhead development programs.

Responsibilities

• Assist with the set up and implementation of a GLP lab to support regulated method validations and sample analysis, including LIMS setup, IQ/OQ/PQs and calibrations
• Help set up/review SOPs and templates related to GLP bioanalysis
• Build and lead a team to support internal regulated bioanalysis
• Lead and mentor a team of bioanalytical scientists, providing technical and career development guidance, including managerial duties such as performance goals, reviews and talent development
• Develop a training program and lead training of junior scientists
• Ensure work is compliant per GLP/GCP regulatory requirements and stay up-to-date on relevant regulations
• Lead method validations of bioanalytical assays via HPLC-FL and LC-MS/MS, evaluate assay and instrument performance, ability to troubleshoot issues
• Lead lab organization and maintain instrumentation
• Conduct peer review of data, protocols and reports
• Effectively manage workload and monitor and evaluate team completion of tasks and projects
• Works collaboratively with cross-functional teams (PM, Clinical, DMPK, QA, QC, Regulatory and others as needed) to develop and meet project goals, deliverables, and timelines
• Track progress against project timelines, generate regular status updates, and communicate progress and issues to management and cross-functional teams
• Multi-task across several projects and manage time effectively to achieve results
• Adhere to safe laboratory practices

Requirements:

• Minimum BS degree with 10+ years or MS with 7+ years or PhD with 5+ years of relevant experience in the pharmaceutical/CRO industry
• Demonstrated method development experience with various analytical platforms and deep expertise with LC-MS and LC-FL
• Demonstrated project and time management
• Experience leading and training other scientists and leading lab organization and processes
• Good documentation practices with excellent organization and attention to detail
• Demonstrated innovation, creativity and resilience in problem solving
• Excellent oral and written communication skills
• Self-motivated team player with the ability to thrive in a fast paced, dynamic, multi-disciplinary, matrixed environment