QC Lab Ops & Operational Readiness Senior Specialist

Job description

Job Description At our Wilmington Biotech Campus, we are committed to keeping the patient at the very heart of all that we do and striving to find solutions and treatments for some of the world’s most challenging healthcare needs. The Wilmington Biotech Campus will play a pivotal role in the manufacture of our company’s biologics-based medicines, including the areas of immuno-oncology. This site will establish our company’s internal capability to manufacture high potent compounds when full manufacturing operations begin in 2029. This facility will be a significant supplier of Antibody Drug Conjugates (ADCs) and High Potent Compounds and will also be critical in the future supply of new biotechnology products to it’s global network. Wilmington Biotech Campus – Quality Control Laboratory The QC Laboratory at Wilmington Biotech Campus will be a transformational facility for the analytical commercialization of our company’s pipeline of high potent Biologics. This laboratory will bring together late-stage analytical method development and validation with commercial release testing to deliver significantly improved speed through the analytical lifecycle. The laboratory will be supported by locally based advanced analytical subject matter experts and digital tools to enable an enterprise-wide connected laboratory in support of a new approach to analytical commercialization for high potent Biologics. The laboratory will be operated under our Manufacturing Division with close collaboration with our Research & Development Division. Reporting to the QC Laboratory Operations Manager, the Laboratory Operations Senior Specialist – Operational Readiness is accountable for end-to-end QC laboratory operational readiness planning and execution in support of a new facility introduction. This role integrates laboratory operations workstreams, including equipment, system, and laboratory start-up readiness activities—into a single executable readiness plan aligned to the site Integrated Master Schedule. The role operates in parallel with construction, commissioning, and qualification activities to ensure the QC laboratory is ready to accept handover and achieve successful facility approval readiness through robust SOPs, training, supply readiness, and risk controls. Upon transition to steady-state operations, this role will own and drive ongoing laboratory operations activities. Key Accountabilities: Integrated Laboratory Operational Readiness Planning & Schedule Build, maintain, and govern the QC laboratory operations readiness schedule across workstreams aligned to the site Integrated Master Schedule and critical path. Drive schedule convergence and acceleration: identify dependencies, sequencing conflicts, resourcing gaps, and pull-forward actions; support weekly lookahead planning and escalation for overdue/at-risk deliverables. Establish laboratory operations readiness stage-gates and define entry/exit criteria with stakeholders to confirm readiness at critical milestones. Partner with cross-functional stakeholders (Quality, Manufacturing, Supply Chain, Facilities/Engineering, our research division, and IT) to align laboratory operations readiness with site start-up timelines. Additional Laboratory Operational Readiness Activities include; SOPs & Document Readiness Coordinate drafting, review, and approval of SOPs, Work Instructions, and Job Aids for laboratory operations activities Maintain a document tracker integrated into the master readiness schedule. Sample Management Develop the end-to-end sample management process (receipt, login, storage, tracking, distribution, retention/disposal). Provide input on system master data and Implement sample workflows within LIMS; ensure chain of custody, traceability, and data integrity compliance. Laboratory Inventory Management Develop inventory control processes for consumables, chemicals, reagents, reference standards, and supplies. Coordinate supplier readiness, material master data, reorder points, and procurement workflows aligned to start-up sequencing. Stability Program Operations Support stability operations including providing input on the design and oversee the start-up of the stability facility and develop the process for sample pull scheduling, storage condition management, and sample distribution. Quality & Compliance Ensure all laboratory operations activities comply with cGMP, corporate quality policies, and regulatory requirements (FDA, EMA, ICH); maintain inspection readiness at all times. Embed data integrity principles (ALCOA+) across all laboratory operations processes, records, and electronic systems. Lead or support deviation investigations, OOS/OOT assessments, root cause analyses, and CAPAs related to laboratory operations as required Manage change controls for laboratory operations processes, systems, and materials; assess impact and ensure proper implementation. POST GO-LIVE: Steady-State Operations Support the long-term daily requirements for laboratory operations across sample management, solution/reagent preparation, inventory management, planning/scheduling, and stability activiies to ensure uninterrupted support of QC testing. Monitor operational KPIs (e.g., sample turnaround time, solution availability, inventory stockout rate, schedule adherence); drive corrective actions for adverse trends. Drive continuous improvement through standard work, lean practices, and automation opportunities; benchmark against network best practices. Lead or support deviation investigations, OOS/OOT assessments, root cause analyses, and CAPAs related to laboratory operations. Manage change controls for laboratory operations processes, systems, and materials; assess impact and ensure proper implementation. Qualifications / experience Education Bachelor's degree in Chemistry, Biochemistry, Engineering, or a related scientific discipline (advanced degree preferred) Experience Minimum 6 years of industry experience working directly in QC testing in a biotech / pharmaceutical or related discipline. Proven experience with laboratory start-up projects, formal project management experience or PMP preferred. Strong quality background with direct experience supporting health authority inspections. Experience in cGMP environments, QC lab operations, and quality management systems is required. Strong working knowledge of LIMS, inventory systems, and digital laboratory tools (e.g., Veeva, Kneat, Biovia). Experience with deviation/OOS investigations, change control, and CAPA processes. Knowledge of data integrity principles and their application to laboratory operations. Demonstrated Lean/Six Sigma or continuous improvement experience. Core competencies and skills Strong organizational skills; able to manage multiple priorities in a dynamic start-up environment. Cross-functional collaboration and stakeholder integration. Attention to detail with commitment to data integrity, compliance, and right-first-time execution. Problem-solving, risk assessment, and clear escalation framing Quality mindset — proactively identifies compliance gaps and drives resolution. Drives change and continuous improvement in a positive way. Additional Info: Location: Wilmington Delaware (On-Site) Travel: Ability to travel ~10% of the time Required Skills: Analytical Instrumentation, Analytical Method Development, Antibody Drug Conjugates (ADC), Data Integrity, Decision Making, Detail-Oriented, Good Manufacturing Practices (GMP), Laboratory Information Management System (LIMS), Laboratory Operations, Laboratory Safety, Lean Six Sigma (LSS), Project Management, Quality Standards, Regulatory Requirements, Risk Analysis, Risk Assessments, Root Cause Analysis (RCA), Sample Management, Scheduling, Stability Testing, Statistical Analysis, Strategic Collaborations, Team Problem Solving, Technical Transfer, Technical Writing Prefer