Job Title

The Manufacturing Operations Lead is accountable for safe, compliant, and efficient delivery of production volumes across assigned dosage forms, while building a high-integrity, high-rigor manufacturing organization . The role carries end-to-end responsibility for batch execution discipline, cycle time adherence, OEE improvement, people capability development, and sustained quality compliance in a USFDA-regulated environment. 1. Production Delivery & Operational Excellence Own achievement of approved production plans (volume, mix, and timelines) with clear accountability for Right-First Time (RFT) execution. Ensure strict adherence to batch cycle times, changeover times, cleaning times, and line utilization norms as per approved standards. Drive continuous improvement in Overall Equipment Effectiveness (OEE) across availability, performance, and quality metrics. Ensure disciplined execution of manufacturing instructions, line clearances, in-process controls, and documentation practices. Proactively identify and eliminate bottlenecks impacting throughput, yield, or schedule adherence. 2. Quality, Compliance & Inspection Readiness Maintain a state of continuous GMP compliance in line with USFDA, EU GMP, and internal quality standards. Be fully accountable for deviation trends, CAPA effectiveness, repeat observations, and human-error reduction within manufacturing. Partner closely with Quality Assurance to ensure robust batch release readiness and zero compromise on data integrity. Lead manufacturing readiness for regulatory inspections, customer audits, and internal audits , including sustained closure of commitments. Reinforce a culture of “Quality over output when in conflict” without dilution of delivery commitments. 3. People Leadership & Capability Building Build and sustain a strong manufacturing leadership bench (production managers, shift leaders, supervisors). Ensure structured skill development, qualification, and certification of operators and officers on equipment, processes, and GMP behaviours. Drive performance management, succession planning, and talent retention within manufacturing teams. Set clear expectations on discipline, ownership, accountability, and ethical conduct at all levels. 4. Behavioural Integrity & Cultural Rigor Act as a role model for Rubicon’s values of Integrity, Passion, Agility, and Solidarity . Enforce zero tolerance for data integrity lapses, undocumented practices, or shortcut behaviours. Create a culture where issues are surfaced early, investigated scientifically, and resolved sustainably . Ensure respectful, transparent, and fact-based engagement across cross-functional teams. 5. Digitization & Special Projects Lead and support digitization initiatives within manufacturing, including electronic batch records, MES interfaces, equipment data capture, and performance dashboards. Drive qualification, commissioning, and validation of new equipment, lines, and manufacturing technologies in collaboration with Engineering and QA. Support scale-up, tech transfer, and capacity expansion projects with strong operational ownership. Champion data-driven decision-making using real-time production, quality, and OEE analytics. 6. Be accountable for manufacturing-led Exhibit Batch Completion , including: Accuracy and completeness of batch records Resolution of execution-stage discrepancies Timely initiation and closure of deviations arising during execution Partner with QA to ensure right-first time exhibit batches , minimizing QA queries, rework, and review loops. Ensure exhibit batches are inspection-defensible , with clear traceability, contemporaneous documentation, and ALCOA+ compliance. Must-Have Skills: List at least 3 points that are necessary to be successful in the role. Points for reference: Degree in Pharmacy / Chemical Engineering / Mechanical Engineering or equivalent. 15+ years of progressive manufacturing leadership experience in USFDA-regulated pharmaceutical environments . Proven track record of high-volume manufacturing with strong compliance outcomes . Hands-on experience with digitization, equipment qualification, and operational excellence frameworks. Problem solving and decision-making ability Excellent communication skills and stakeholder management skills Key Interfaces Quality Assurance & Quality Control Engineering & Projects Planning & Supply Chain EHS Corporate Operations Excellence / Digital Transformation Teams Success Measures (KPIs) Production plan adherence (% on-time, in-full) Batch cycle time and cleaning time adherence OEE improvement trends RFT and deviation reduction metrics Inspection outcomes and audit closure effectiveness Attrition, capability depth, and leadership readiness in manufacturing teams