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 abilityExcellent communication skills and stakeholder management skillsKey Interfaces- Quality Assurance & Quality Control - Engineering & Projects - Planning & Supply Chain - EHS - Corporate Operations Excellence / Digital Transformation TeamsSuccess 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 effectivenessAttrition, capability depth, and leadership readiness in manufacturing teams