Self-motivated, results-driven, decision maker, hands-on problem solver with an ambition to succeed in any given environment. Extensive experience in pharmaceutical (non-sterile, sterile, and biologics) quality control testing, supervision and laboratory investigations. R&D knowledge and practical experience in method development, validation and transfer in the OTC consumer business. Experienced in project management, process improvement, regulatory inspections/audits, GMPs, and technical writing. Thrive in learning new things and always up for a challenge whatever the situation. Searching for a challenging and dynamic opportunity with an organization that can benefit from my diverse experience, strong analytical background, strategic thinking, and leadership skills, while offering the opportunity to acquire new experiences and skills. Major strengths include leadership, strategy, planning and scheduling, collaborating, building partnerships, process improvement and process waste elimination, problem resolution, Lean Six Sigma methodology. Dynamic restaurant entrepreneur, negotiator and influencer.
INDEPENDENT AND COMPANY SPONSORED COURSES
Facilitative Leadership I
Problem Solving/Decision Making
Analytical Problem Solving
Win-Win Conflict Resolution
Writing Effective and Concise Investigations
Management and Leadership Organizational Design
First Line Leader
Flawless Project Execution (FPX) Methodology
Negotiation and Conflict Resolution
Lean Six Sigma Yellow Belt Certified
Leadership and Coaching Essentials
08/2012 to Current
R&D ManagerJOHNSON AND JOHNSON CONSUMER HEALTHCARE － Fort Washington, Pennsylvania
Manage a team comprised of both McNeil full time employees and contractors.
R&D Analytical Lead and Subject Matter Expert in various cross-functional projects, supporting analytical method development, validation, and transfer, USP method equivalency studies, and analytical method remediation projects.
Participate in various technical review committees and forums, which are intended to provide subject matter expertise and ensure consistency and compliance throughout the product project portfolio.
Provide analytical support for Product Development and Validation, Site Transfers, Product Launches.
Provide R&D Subject Matter Expertise in Notification to Management Meetings in the case of an Adverse Quality Event.
Provide support to quality initiatives that are part of the Consent Decree work plan.
Support internal and external analytical method development, validation and transfer to testing sites.
Lead laboratory investigations at J&J Consumer OTC and External Manufacturing (EM) sites and drive timely resolution through collaborative partnerships.
Develop and analyze project scenarios and timelines, risk assessments and mitigation plans.
Work directly with internal and EM sites for unknown impurities identifications.
Partner with EM Quality Assurance and EM Operations to influence improvements at the external sites which increase efficiencies and reduce compliance risks for J&J Consumer OTC.
Provide analytical subject matter expertise to both commercial sites and internal J&J organizations.
Provide analytical support to Marketed Products.
Review/approve laboratory investigations and CAPAs.
01/2005 to 01/2007
Co-Owner and General ManagerZANA D RISTORANTE - Italian Fine Dinning － Warwick, New York
Responsible for vendor/supplier contract negotiations and renewals.
Led multiple continuous business improvement projects, both in kitchen and dining floor.
Identified and eliminated business process waste by 40% in efforts to reduce cost and increase efficiencies.
Directly responsible for marketing strategies and increasing sales/revenue by 35% within 2 years.
07/2001 to 07/2012
Senior Laboratory Supervisor/ Laboratory Supervisor/ Senior Analytical ChemistMERCK & CO., INC － West Point, Pennsylvania
Responsible for all aspects of laboratory testing under my supervision, including coordination and scheduling of work, employee motivation and development, training, and problem resolution.
Developed and implemented productivity improvements, maintained adequate inventory supplies, training records, identified and implemented corrective action/preventive action, analyzed equipment utilization and resource constrains.
Valuable experience with 21 CFR Part 210 and 211 GMP's for Pharmaceuticals.
Served as a laboratory representative at manufacturing Tier 3 daily meetings, providing testing updates to upper management and proactively escalating potential issues to Tier 4 (Senior Leadership).
Collaborated and partnered with other departments (Manufacturing, Technical Operations, Planning, and Product Release) in order to improve sample flow and customer service.
Critical team member of a cross-functional initiative using Lean Six Sigma Principles to reduce Make-to-Ship product cycle flow from 75 days to 42 days.
Partnered with Laboratory Technical Support to identify and incorporate test method improvements to reduce the method invalid rate for a commercial vaccine product from 30% to 2%.
Analytical lead on a two-phase Lab Green Belt Project to improve testing efficiencies for a dual-active diabetes product by increasing testing capabilities from 30 batches/month to 64 batches/month, then 90 batches/month by using the same number of FTEs and automating part of the testing operation.
Identified inefficiency eliminating and performance improvement opportunities, implemented and executed changes, monitored progress/results.
Improved process cycle based on feedback.
Investigated and determined root cause for over 200+ atypical laboratory events.
Responsible for technical aspects of fact finding.
Implemented the necessary corrective actions to prevent reoccurrence.
Established clear expectations, SMART goals, and monitoring of performance and efficiency.
Performed qualitative/quantitative analytical testing on raw materials, development and process validation samples, and finished sterile and non-sterile pharmaceutical.
Subject Matter Expertise in HPLC, UV, Dissolution.