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
