Kiran Sharma
Piscataway,USA
Summary
Results-driven Operations and Process Excellence Leader with 20+ years of experience leading large-scale manufacturing, sterilization, and regulated operations across healthcare, biotech, pharmaceutical, food, and chemical industries. Proven expertise in Lean Six Sigma, operational strategy, workforce leadership, and regulatory compliance (FDA, AATB, cGMP, ISO, OSHA). Recognized for building high-performing teams, optimizing throughput, improving quality, and delivering measurable cost savings. Adept at leading multi-shift operations, developing leaders, and aligning operations with enterprise goals.
Overview
17
17
years of professional experience
Work History
Manager, Sterilization, Lyophilization & Processing Operations
MTF BIOLOGICS
Edison, NJ
01.2018 - Current
- Lead enterprise-level sterilization, lyophilization (LYO), and processing operations supporting tissue processing in a highly regulated environment.
- Provide strategic and operational oversight across multiple shifts, ensuring safety, compliance, efficiency, and continuous improvement across all processing functions.
- Lead 70 non-union employees, including 4 Supervisors, 1 Associate Manager and 9 Team Leaders, across Sterilization, Lyophilization, and Processing Operations.
- Oversee end-to-end processing workflows, including decontamination, assembly, cleaning, sterilization, lyophilization, staging, and material flow supporting multiple processing departments.
- Provide 24/7 operational support, ensuring uninterrupted production, rapid issue resolution, and alignment with business priorities.
- Manage and optimize sterilization and lyophilization processes in accordance with SOPs, validated protocols, and regulatory requirements.
- Ensure compliance with FDA, AATB, OSHA, EHS, USP, and internal quality systems, supporting audit readiness and regulatory inspections.
- Drive cross-functional collaboration with Processing, Quality, Engineering, Validation, and Supply Chain teams to improve throughput, efficiency, and product flow.
- Develop and monitor KPIs, staffing models, and capacity plans to meet production demand and long-term growth needs.
- Lead continuous improvement initiatives using Lean, Six Sigma, and process mapping tools to reduce waste, improve cycle time, and standardize work.
- Oversee personnel, financial, and operational planning, including labor optimization, overtime management, and departmental budgeting.
- Mentor and develop supervisors and team leaders through coaching, performance management, and succession planning.
- Partner with senior leadership to establish strategic goals, operational standards, and scalable systems aligned with organizational growth.
Production Supervisor
SIKA CORPORATION
Lyndhurst, NJ
01.2017 - 01.2018
- Managed 30 union employees and ensured shift meets profitable production goals and quality goals, while meeting company goals for safety, quality, delivery, and cost.
- Directed and coordinated activities ‐ planned, organized, and controlled production to ensure that goods are produced efficiently, on time, and to the standard.
- Acted as interface between plant management and production staff.
- Coached, mentored, and developed the team.
- Lead continuous improvement programs and manufacturing process improvements by applying appropriate processes and problem-solving tools such as Lean Manufacturing, Six Sigma, etc.
- Helped in the identification and development of standardized procedures and training materials.
Production Supervisor
The Hershey Company
Hazelton, PA
01.2015 - 01.2017
- Supervised 30 hourly union production personnel and temporary labor across two production lines on both a daily and per-shift basis.
- Drove and supported all plant goals, coordinated labor/staffing, and managed information sharing and communications to all direct reports and peers.
- Ensured compliance with established standards and procedures for safe food quality (SFQ), employee safety, sanitation, current Good Manufacturing Practices (cGMP), housekeeping, and other plant programs.
- An integral and contributing member of the Hershey Lean Process Improvement team.
- Drove continuous improvement (CI) and fostered a continuous improvement mindset that elevated new ideas and executed CI plans that positively impacted plant operations and goals.
- Transformed a poorly performing production line from operating at a $300K loss to an efficient operation that was $400K in the black.
- Implemented process improvements that increased production uptime to 80%, cut changeover time 30% and slashed 60% waste.
- Worked with Lean Manager and coached employees on reducing changeover times, optimizing machine speed, reducing waste, rework and start-up times, machine stops, and cleaning times.
- Trained and mentored staff on lean concepts and lean project implementation practices.
- Coached teams on fishbone diagrams, root cause analysis, and Statistical Process Control charts.
- Eliminated non-value added steps with process mapping, 5S implementation, SMED training, and by facilitating Kaizen events.
Production Supervisor
Avantor Performance Materials
Phillipsburg, NJ
01.2010 - 01.2015
- Supervised a team of 32 hourly union employees of all 3 shifts in adherence to plant safety, EHS&S regulations, ISO, cGMP, housekeeping and environmental policies.
- A key member of the Lean Six Sigma implementation team.
- Supported regulatory activities such as training, validation studies, scale-up of new products, corrective and prevention action (CAPA), complaint response, and internal and external audits.
- Worked with McKinsey & Company on a project that focused on maximizing production, reducing waste and overtime, and increasing OEE.
- Efforts resulted in an 85% increase in productivity.
- Improved uptime to 85% from 60%, directly contributing to achieving and maintaining weekly schedule attainment goals above 95% and a 15% reduction in customer complaints.
- Maintained outstanding safety record with zero incidents for 3 years.
- Eliminated Saturday operation by consistently meeting production goals, being persistent and staying focused on speed, quality, and safety.
Production Supervisor
Corepharma LLC
Middlesex, NJ
01.2009 - 01.2010
- Provided direction to a total of 25 non-union production personnel.
- Enforced SOPs that ensured performance met and exceeded established safety, Quality/current Good Manufacturing Practices (cGMP), and cost standards.
- Mentored and counseled hourly employees.
- Organized production schedule for dispensing, granulation, and compression of solid dosage form.
- Developed and streamlined 3rd shift that received recognition for increasing production output by 45% through coordinating the workforce and by minimizing downtime.
- Planned, wrote, and initiated Standard Operating Procedures intended for equipment operation and manufacturing processes.
Production Manager
Fresenius Medical Care
, Canada
- Increased production output by 25%, reduced overtime, and improved safety metrics by 20%.
Quality Control Technician
Fresenius Medical Care
- Performed analytical testing and supported R&D scale-up initiatives.
Operational Excellence Manager
Les Teinturiers Concorde Dyers
- Improved production output by 40% through quality system improvements.
Education
Lean Six Sigma Black Belt Certification of Achievement -
Villanova University
Pennsylvania, USAMaster of Business Administration -
University of Massachusetts
Massachusetts, USACertificate in Bio-Industrial Process Technology -
John Abbott College
Montreal, QCMaster of Science -
Punjab Agricultural University
Punjab, IndiaBachelor of Science -
Punjab Agricultural University
Punjab, IndiaSkills
- Operations & Manufacturing Leadership
- Sterilization & Lyophilization Operations
- Lean Six Sigma
- Continuous Improvement
- Process Mapping
- PCA (Process Compression Analysis)
- Regulatory Compliance
- KPI Development
- Capacity Planning
- Workforce Planning
- Leadership Development
- Audit Readiness
- Quality Systems
- SOP Development
- Technical Documentation
- Budgeting
- Labor Optimization
- Cost Control
Education Credentials
- Lean Six Sigma Black Belt Certification of Achievement, Villanova University, Pennsylvania, USA
- Master of Business Administration, University of Massachusetts, Massachusetts, USA
- Certificate in Bio-Industrial Process Technology, John Abbott College, Montreal, QC
- Master of Science, Punjab Agricultural University, Punjab, India
- Bachelor of Science, Punjab Agricultural University, Punjab, India
Early Career Experience
- Production Manager, Fresenius Medical Care (Canada), Increased production output by 25%, reduced overtime, and improved safety metrics by 20%.
- Quality Control Technician, Fresenius Medical Care, Performed analytical testing and supported R&D scale-up initiatives.
- Operational Excellence Manager, Les Teinturiers Concorde Dyers, Improved production output by 40% through quality system improvements.
Strengths Values Offered
- Operations & Manufacturing Leadership
- Sterilization & Lyophilization Operations
- Lean Six Sigma / Continuous Improvement
- Process Mapping & PCA (Process Compression Analysis)
- Regulatory Compliance (FDA, AATB, USP, ISO, OSHA, EHS)
- KPI Development & Capacity Planning
- Workforce Planning & Leadership Development
- Audit Readiness & Quality Systems
- SOP Development & Technical Documentation
- Budgeting, Labor Optimization & Cost Control
Timeline
Manager, Sterilization, Lyophilization & Processing Operations
MTF BIOLOGICS
01.2018 - Current
Production Supervisor
SIKA CORPORATION
01.2017 - 01.2018
Production Supervisor
The Hershey Company
01.2015 - 01.2017
Production Supervisor
Avantor Performance Materials
01.2010 - 01.2015
Production Supervisor
Corepharma LLC
01.2009 - 01.2010
Production Manager
Fresenius Medical Care
Quality Control Technician
Fresenius Medical Care
Operational Excellence Manager
Les Teinturiers Concorde Dyers
Lean Six Sigma Black Belt Certification of Achievement -
Villanova University
Master of Business Administration -
University of Massachusetts
Certificate in Bio-Industrial Process Technology -
John Abbott College
Master of Science -
Punjab Agricultural University
Bachelor of Science -
Punjab Agricultural University