Manager, Lab Operations

Manager, Lab Operations is accountable for the daily operational, facility readiness, and compliance of Quality control laboratories. The manager will also coordinate cross functional efforts between the lab operations group and other supporting departments to ensure laboratory safety, vendor management, material availability, facility and equipment maintenance, on time closure of quality events, and end-user training. This individual also acts as the validation system owner for scientific equipment and will work with group leads for necessary development/qualification activities. The position requires superior leadership, scientific experience, and the ability to clearly communicate with the internal department and external department. Primary Responsibilities: Provide scientific and technical guidance and serve as the subject matter expert (SME) including but not limited to flow cytometry, molecular, microbioloy, and analytical capabilities. Lead lab operations with respect to coordination with internal and external partners for tasks such as work orders, equipment or facility projects, material/waste workstreams, and revisions to operational procedural documentation. Support GMP Testing Operations. Perform and manage analytical system validation and release. Conduct technical and laboratory investigations for multiple cell and gene therapy programs. Advance scientific understanding of gene therapy products and analytical techniques. Maintain current awareness of GMP/GTP and other regulations, guidance documents, advisory committees, industry standards, and trends that are applicable to current and future cell and gene therapy development operations and product. Open, investigate, and close deviations, change controls, CAPAs and other quality events. Oversees the daily workflow of the department. Perform additional duties as assigned. Education, Experience, & Qualification: Bachelor’s degree in a scientific or engineering discipline required; Master’s degree preferred. 7 years of related pharmaceutical experience required, including relevant experience in manufacturing in a GMP environment. Advanced formal training, degree or certification(s) preferred. Proven ability to work well under pressure and adapts quickly to change. Skilled at planning, organizing, prioritizing, and executing simultaneous projects and activities. Knowledge on Part 11 and Annex 11 Compliance. Understanding of Veeva and Valgenesis is preferred. Good Manufacturing Practice experience is strongly preferred Key Competencies: Excellent verbal and written communication skills. Excellent interpersonal and customer service skills. Excellent organizational skills and attention to detail. Excellent time management skills with a proven ability to meet deadlines. Strong analytical and problem-solving skills. Strong supervisory and leadership skills. Ability to prioritize tasks and to delegate them when appropriate. Ability to function well in a high-paced and at times stressful environment. Proficient with Microsoft Office Suite or related software. Physical Requirements: Prolonged periods of sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times. #J-18808-Ljbffr