Summary
Overview
Work History
Education
Skills
Certification
SUMMARY OF QUALIFICATIONS
Timeline
Generic

MANUEL SARDINAS

Cliffside Park

Summary

Operations leader with a strong track record in driving operational excellence and implementing strategic initiatives. Achieved $2 million in annual savings through effective procurement strategies while improving compliance and service levels. Proven leadership and process optimization skills position for success in a chief operating officer role.

Overview

1
1
Certification
23
23
years of professional experience

Work History

Vice President of Quality and Operations

Parker Laboratories
11.2016 - Current
  • Managed $75M P/L, overseeing product development, engineering, manufacturing, packaging, press, purchasing, logistics, regulatory, quality assurance, and quality control for medical device ultrasound and electromedical contact media, ensuring operational efficiency and compliance.
  • Drove procurement and raw material strategy changes yielding $2M in annual savings, directly improving profit margins
  • Implemented domestic RM which yielded $500k annual savings and reduced failed batches to 0.001%
  • Implemented 3 Delta Mods with $8M investment, targeting 60% ROI through enhanced operational processes.
  • Led ERP Sage X3 implementation of V12 from obsolete version. Reduced $120k in annual savings in unnecessary and duplicate testing
  • Integrated Quality department with Sales and Operations, enhancing visibility of supply chain issues, facilitating clearer decision-making, and improving documentation of quality issues.
  • Implemented Mastercontrol and executed document control, engineering change control, training modules, Calibration and PMs yielding a massive success in document traceability, deployment and training (Previous system was paper based)
  • Achieved superior results as Audit Chair for EU regulatory body BSI, FDA, and KFDA.
  • Managed the purchase and installation of an Olsa 1500L sanitary skid, designed to improve an emulsion process from 36 hrs to 1.5 hrs and improve the long-term process capability

Director of Operations

Parker Laboratories
11.2016 - 12.2022
  • Oversaw product development, engineering, manufacturing, packaging, press, purchasing, master planning, and logistics for pharmaceutical, medical device ultrasound, and electromedical contact media (18 direct, 65 indirect)
  • Led $5.1M construction project while maintaining operational continuity of manufacturing facility
  • Orchestrated technical implementation and commissioning of seven ISO class 8 clean rooms, reducing product contamination risk to zero – Developed statistical model to address prior FDA findings
  • Organized the purchase, validation, commissioning, and Kaizen improvement of a Coesia Volpak SP70, which increased per shift capacity by 67% and reduced labor needed by 3FTEs. (Cost $0.4M, ROI 365%)
  • Led plan to invest in induction vessels, which resulted in the validation and commission 2 EKATO SRA4000 units, yielding savings of $1.5M/Y in material cost savings and PKG labor reduction of 15 FTEs (ROI 120%), batch quality improved from 3
  • To 6?, batch time reduction from 36 hr to 1.5 hr (Created a clear competitive moat for Parker Labs)
  • Organized 15 RFPs YTD and coordinated efforts that yielded $2.5M/year in cost reduction.
  • Restructured Press Operations and developed area KPIs for 40% improvement in on-time performance
  • Implemented robotic inspection systems to eliminate defects in the packaging process and eliminated 4 FTE
  • Coached and launched 15 individual-driven Green Belt projects (VSMs, Mistake-proofing, Cycle time, Line balancing) yielding savings of an additional $1.9 M/Y
  • Reduced company-wide backorders to zero even during COVID by use of good communication, shift planning, and a backup vendor matrix
  • Established pull systems in packaging and press to streamline workflow

Senior Manager Operations CSO – Americas

Bristol-Myers Squibb
01.2012 - 01.2016
  • Manage 9 operations in the Americas: Argentina, Brazil, Canada, Chile, Colombia, Mexico, Peru, US-NB, US-MTV (9 direct, 20 indirect reports)
  • Key accountable for logistics operations in the Americas: replenishment of Americas, EU, ASIA PAC depots, local depot operations in the Americas, audit and develop country depots
  • Directed transportation contract management and execution, vendor metrics analytics, quarterly business review (QBR) process, and vendor procurement strategy.
  • Responsible for SAP inventory valued over USD1B, management of use-date process and relabeling operations, distribution of temperature sensitive products, SAP Logistics approver
  • Led S.O.M.E. restructuring for order execution process and developed cross-functional responsibility matrix.
  • Implemented Credo and Credo Xtreme in a global scale raising performance in cold-chain distribution and producingd savings of $9M/year including the purchase of 40 units
  • Managed RFP and implementation of local distribution partners in Chile, Mexico and Brazil
  • Created and implemented standard operating procedures for the CSO supply chain.
  • Mapped CSO supply chain and implemented Quality Risk Management program, achieving ISO 31000 compliance for CSO team.
  • Developed share point collaboration sites for each Americas operations distribution centers and automated processes through Infopath solution
  • Implemented and contract management of CSO drug returns vendor (Genco)
  • Assembled a team to manage the clinical orders lifecycle of the BMS portfolio – Order deployment, site-facing interaction, Proforma (5000 orders/m, 150 Proformas/m – global clinical supply chain coverage
  • Manage Invoicing, vendor expenses and financial planning, expertise in financial modeling
  • Lead Local-purchase of clinical product pilot, Conducted drug supply remediation plan
  • Lead CSO Operation Excellence Forum, Member of Logistics Security Council Team

Production/Operations Manager

STERIS Isomedix
01.2010 - 01.2011
  • Oversaw three supervisors to ensure effective team management., 3 Technical and Logistics planners, and 10 indirect reports
  • Implemented attendance policy, expanded operations to 24/7, and formalized supervision structure to enhance team accountability.
  • Piloted Kaizen event yielding $100K YE2011, Managed CAPA approval and implementation
  • Led control system decommissioning and implementation
  • Introduced and drove discipline guideline for managing performance, 75% OT reduction
  • Developed Quality Steering committee yielding standard practices and monthly metrics
  • Facilitated FDA preparedness meetings to achieve compliance and readiness for regulatory inspections.
  • Facilitate customer relations, resolve conflict and negotiate agreements
  • Executed DuPont’s STOP program, implemented safety audits, safety gates, walkways, security cameras, and radio system; drove installation of 2 fire-tube boilers to improve safety infrastructure.

First Line Manager

GlaxoSmithKline (GSK)
01.2010 - 01.2010
  • Managed 2 team leaders and 14 indirect reports in Sensodyne, Aquafresh manufacturing, enhancing team alignment and operational effectiveness
  • Developed and implemented risk and safety hazards action plan for packaging and manufacturing, improving workplace safety standards
  • Managed CAPA completion of Manufacturing department (Dating to 2005)
  • Implemented discipline guidelines for performance management of hourly employees, ensuring accountability and consistent performance evaluations

Production Supervisor

L'OREAL USA
01.2004 - 01.2009
  • Supervised 24 direct reports in bulk manufacturing operation (mechanics, manufacturing, material preweigh/compounding)
  • Optimized manufacturing practices $520K/YE2009 and RFT increase from 88% to 97% YE2009
  • Enhanced CD3 System operations, achieving 30% cycle time reduction, saving $110K YE 2009
  • Achieved $1.2M YE 2008 by optimizing batch sizes such as Developer, ACC, and shampoos Developed PPE procedure based in operation area
  • Reached 99% adherence in bulk plan YE 2009 by using effective and timely communication
  • Implemented an automated system to streamline the reordering process for bulk raw materials.
  • Key player implementing SAP in facility, troubleshooting opportunities and training employees

Process Expert – Process engineer

L'OREAL USA
01.2005 - 01.2008
  • Drove process improvement in cream dye production for Natural Match, Excellence, Nutrisse, Color Expert and 100% Color reducing cycle times by 55% creating gains of $120K/Y
  • Implementation of After-Color conditioner optimizations for increase of the conditioner RFT from 60% to 90% and cycle reductions of 30%, Developed the Hot-Cold Project producing gains of $500K/Y
  • Led batch scale-up, BOM configuration, PLC recipe creation, and batch improvement initiatives.
  • Executed bulk production launches for E2GO Dye, Natural Match Dye, Feria Dye Restage, Excellence Dye Restage, Preference Dye Restage, Dark and Lovely, Dark and Natural Dyes, Nutrisse Dye Restage, Reviving Colors Dyes, and Fructis products.
  • Created and maintained bulk stability system to evaluate bulk characteristics producing trends to evaluate batches over time and achieved 99% process validation
  • Secured plant FDA permits for launch and programmed batch recipes into multiple systems.
  • Managed launches in Subcontracted facilities: Medicia, Bright International, Hair Systems

Analytical Chemist

L'OREAL USA
01.2005 - 01.2005
  • Conducted analytical testing of manufactured bulk using wet chemistry methods to ensure product quality and compliance.
  • Developed database to track shift performance, improving transparency and accountability within operations.
  • Implemented database system to facilitate effective shift-to-shift communication, streamlining information exchange.

Industrial Quality Technologist

L'OREAL USA
01.2004 - 01.2005
  • Inspected finished goods and conducted internal and supplier audits to ensure compliance with quality standards.
  • Developed and maintained secured access database for tracking non-conformances, improving data accessibility and accuracy.
  • Performed start-up line validations on two newly implemented high speed lines
  • Researched and implemented infrared sensors on cream dye lines, enhancing automation of antioxidant solution application.

Education

M.E. - Chemical Engineering

Stevens Institute of Technology
Hoboken, NJ
05-2003

B.E. - Chemical Engineering

Stevens Institute of Technology
Hoboken, NJ
05-2003

Skills

  • Product development
  • Quality assurance
  • Regulatory compliance
  • Supply chain management
  • Lean manufacturing
  • Cost reduction
  • Process improvement
  • Process optimization
  • Project management
  • Data analysis
  • MRP systems expertise
  • Statistical process control
  • Performance management
  • Operational efficiency
  • Risk management
  • Budget oversight
  • Cost reduction strategies
  • Change management
  • Team leadership
  • Strategic planning
  • Metrics tracking
  • Conflict resolution
  • Effective communication
  • LSS black belt
  • Complex Problem-solving
  • Cost reduction strategies

Certification

  • Certified Lean Six Sigma Black Belt, 2018, Rutgers State University School of Business (Lockheed Martin LSS program)
  • Certified Lean Six Sigma Green Belt, 2018, Rutgers State University School of Business (Lockheed Martin LSS program)
  • Certified Lean Six Sigma Kaizen Leader, 2015, Bristol-Myers Squibb LSS program
  • Certified Supply Chain Professional (CSCP), 2012

SUMMARY OF QUALIFICATIONS

Fluent in English and Spanish (verbal and written)

Timeline

Vice President of Quality and Operations

Parker Laboratories
11.2016 - Current

Director of Operations

Parker Laboratories
11.2016 - 12.2022

Senior Manager Operations CSO – Americas

Bristol-Myers Squibb
01.2012 - 01.2016

Production/Operations Manager

STERIS Isomedix
01.2010 - 01.2011

First Line Manager

GlaxoSmithKline (GSK)
01.2010 - 01.2010

Process Expert – Process engineer

L'OREAL USA
01.2005 - 01.2008

Analytical Chemist

L'OREAL USA
01.2005 - 01.2005

Production Supervisor

L'OREAL USA
01.2004 - 01.2009

Industrial Quality Technologist

L'OREAL USA
01.2004 - 01.2005

M.E. - Chemical Engineering

Stevens Institute of Technology

B.E. - Chemical Engineering

Stevens Institute of Technology
MANUEL SARDINAS