Laboratory Operations Lead

Be the First to Apply Division Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. For more details, please visit : Job Title QC Chemistry Supervisor, 2nd Shift Job Description The QC Laboratory Operations Lead is responsible for coordinating and driving the day-to-day operational execution of the Quality Control laboratory across Chemistry, Microbiology, and Stability functions. This role serves as the primary operational partner and right-hand support to the QC Chemistry Supervisor, QC Microbiology Supervisor, and Stability Program Coordinator, ensuring laboratory priorities are integrated into a single executable QC operations plan. The QC Laboratory Operations Lead will own the development, maintenance, and execution of the QC Laboratory Operations Schedule, ensuring testing activities, stability commitments, investigations, training requirements, and customer/manufacturing priorities are appropriately planned, resourced, tracked, and escalated. This position will also play a key role in laboratory investigations, operational performance, continuous improvement, training coordination, and elimination of laboratory bottlenecks. The role requires strong technical knowledge, project management capabilities, cross-functional leadership, and the ability to operate effectively in a fast-paced CDMO environment with competing customer and manufacturing priorities. The position does not replace the technical or personnel leadership responsibilities of the Chemistry and Microbiology Supervisors. Rather, it provides cross-laboratory operational leadership, enabling the supervisors and Stability Program Coordinator to focus on technical oversight, personnel development, compliance, and scientific decision-making while ensuring laboratory commitments are executed effectively. Key Responsibilities QC Operations Planning & Scheduling Own the QC Laboratory Operations Schedule across Chemistry, Microbiology, and Stability activities. Develop and maintain an integrated laboratory schedule incorporating: Raw material testing In-process testing Finished product/release testing Microbiological testing Environmental monitoring testing, as applicable Stability pulls and testing Validation and qualification testing Investigation-related testing Customer-specific testing commitments Method transfer and method verification/validation activities Translate manufacturing schedules, customer commitments, stability requirements, and Quality priorities into executable laboratory plans. Conduct routine schedule reviews with QC leadership and laboratory personnel to identify upcoming workload, constraints, and risks. Evaluate laboratory capacity, analyst availability, instrument availability, testing lead times, and competing priorities when developing schedules. Establish clear testing priorities and coordinate adjustments when manufacturing schedules or customer requirements change. Identify potential delays before they impact batch release, stability commitments, manufacturing schedules, or customer deliverables. Escalate capacity constraints, resource gaps, instrument limitations, material availability issues, or other barriers requiring management intervention. Partner with Planning, Manufacturing, Quality Assurance, Project Management, and other functions to align QC activities with site priorities. Track planned versus actual laboratory execution and identify recurring causes of schedule misses. Laboratory Investigations Lead and/or author laboratory investigations, including: Out-of-Specification (OOS) results Out-of-Trend (OOT) results Laboratory deviations Invalid or atypical test results Instrument and analytical events Laboratory errors and procedural deviations Ensure investigations are scientifically sound, timely, comprehensive, and compliant with applicable procedures and regulatory expectations. Coordinate investigation activities across analysts, supervisors, QA, Manufacturing, Technical Services, and other SMEs as required. Facilitate root cause analysis using appropriate investigation methodologies. Ensure investigation conclusions are supported by objective evidence and scientific rationale. Develop and support effective corrective and preventive actions (CAPAs) resulting from laboratory investigations. Monitor investigation aging and drive timely closure of open laboratory records. Identify recurring laboratory investigation themes and recommend systemic corrective actions. Laboratory Operational Excellence & Continuous Improvement Identify and implement improvements to increase laboratory throughput, efficiency, predictability, and right-first-time execution. Evaluate laboratory workflows to identify bottlenecks, unnecessary handoffs, scheduling inefficiencies, and opportunities for standardization. Lead or support improvement initiatives related to: Sample lifecycle management Testing turnaround time Laboratory scheduling Analyst utilization Instrument utilization Documentation workflows Investigation cycle time Stability testing execution Data review and approval Develop standard work and operational processes that improve laboratory execution while maintaining GMP and data integrity requirements. Support implementation of Lean, visual management, tiered accountability, or other operational excellence tools within QC. Partner with laboratory leadership to reduce testing backlog and improve schedule adherence. Use laboratory metrics and trends to identify performance gaps and improvement opportunities. Training & Analyst Readiness Support laboratory training personnel in planning, coordinating, and tracking QC training activities. Ensure analyst qualification and training priorities align with current and future laboratory workload. Work with QC Supervisors to identify cross-training opportunities that improve laboratory flexibility and reduce single points of failure. Coordinate training schedules to balance qualification requirements with routine testing demands. Support development and implementation of laboratory training materials, qualification programs, and competency assessments. Monitor training and qualification status and elevate gaps that could impact laboratory capacity or execution. Support onboarding and qualification planning for new QC personnel. Stability Program Support Partner closely with the Stability Program Lead to ensure stability pulls, testing, data review, investigations, and reporting activities are appropriately incorporated into the QC Operations Schedule. Ensure stability testing commitments are prioritized and completed within established procedural and regulatory timelines. Identify potential stability testing delays and coordinate recovery plans with Chemistry, Microbiology, and Quality leadership. Support investigation and resolution of stability-related laboratory events and testing issues. Provide operational support for stability backlog management and execution of customer commitments. QC Performance Management Develop, maintain, and communicate laboratory operational metrics, including: Testing schedule adherence Testing turnaround time Samples received versus completed Testing backlog and aging OOS/OOT/deviation aging Investigatio n cycle time Stability testing schedule adherence Analyst qualification status Instrument availability/utilization Right-first-time performance On-time batch testing/release support Provide routine QC operational updates to laboratory and Quality leadership, highlighting performance, upcoming risks, resource constraints, and required actions. Support daily and weekly QC operational meetings and ensure actions, priorities, owners, and due dates are clearly established and followed through to completion. Compliance & Quality Systems Ensure QC operational activities are performed in accordance with GMP requirements, approved procedures, specifications, analytical methods, and data integrity expectations. Support inspection readiness and participate in regulatory and customer audits as required. Support responses to laboratory-related audit observations and regulatory commitments. Participate in change controls, deviations, CAPAs, method transfers, method validation activities, and other Quality System processes affecting laboratory operations. Promote strong documentation practices and a culture of compliance, ownership, accountability, and continuous improvement. Cross-Functional Responsibilities The QC Laboratory Operations Lead will work closely with: QC Chemistry Supervisor - testing priorities, analyst capacity, instrument availability, investigations, training, and execution risks. QC Microbiology Supervisor - microbiological testing priorities, environmental monitoring activities, investigations, analyst readiness, and capacity planning. Stability Program Lead - stability pull schedules, testing commitments, overdue risks, investigations, and customer timelines. Quality Assurance - investigations, deviations, CAPAs, batch disposition priorities, change controls, and compliance activities. Manufacturing & Planning - production schedules, in-process testing, release testing priorities, and manufacturing support. Project Management / Customer Teams - customer commitments, testing timelines, project priorities, and risk communication. Technical Services / Analytical Development - method transfers, technical troubleshooting, validation activities, and analytical improvements. Decision-Making & Authority The QC Laboratory Operations Lead is expected to: Establish and communicate daily and weekly laboratory execution priorities in alignment with QC leadership. Adjust laboratory schedules based on changing business and operational priorities. Coordinate resources across QC workstreams in partnership with functional supervisors. Escalate resource, capacity, compliance, and schedule risks to QC and Quality leadership. Drive investigation execution and cross-functional follow-up. Initiate laboratory improvement activities based on performance trends. Hold stakeholders accountable for agreed operational actions and timelines. Technical decisions related to analytical methods, microbiological science, personnel performance, and final Quality disposition remain with the appropriate functional leadership and Quality Unit authority. Bachelor of Arts (BA) #J-18808-Ljbffr JobRx, Inc.