Laboratory Manager, Product Development QA

Purpose Primarily responsible for leading Product Development QA from an analytical perspective in support of clinical supply release. Responsibilities Support CMC teams in resolving complex technical Analytical challenges through various phases of development Provide leadership and daily support to the Lab QA team Drive continuous process improvement within Product Development QA by updating/authoring policies, processes, procedures, and related documents Lead QA Analytical audit/inspection preparation activities and support audits/inspections as the QA SME Develop, maintain, and report key quality metrics to Management Lead for analytical testing batch release; coordinate and resolve issues Review and approve excipient, drug substance, and product specifications, including justification and revisions Write/review/approve exception reports, including high impact and complex ERs impacting multifunctional areas Approve Laboratory investigations Assess compliance to regulations and industry practice and implement applicable process changes Qualifications Bachelor’s degree or equivalent experience required (typically life sciences or engineering); Master’s preferred 6–8 years of experience in a related field, preferably with quality assurance and/or analytical sciences Strong understanding of Active Pharmaceutical Ingredients (API) and drug product GMP manufacturing as applied to laboratory operations Strong understanding of Quality Assurance principles and systems Strong understanding of US and international regulations for quality systems and compliance for investigational products Experience in project management, coordination, and planning of complex activities Collaborative, risk-based approach to problem solving Effective oral and written communication to clearly communicate quality position and actions needed to resolve issues Ability to present and justify quality requirements across all levels of management Benefits (as stated) Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees Eligible to participate in long-term incentive programs #J-18808-Ljbffr Scorpion Therapeutics