Summary
Overview
Work History
Education
Skills
Timeline
Generic

Michael Scibilia

Lewiston,NY

Summary

Meticulous and well-trained laboratory team member bringing top-notch expertise in analyzing materials and contributing to successful product development. Solid background boosting quality of production with systematic review and on-going support. Demonstrated knowledge of experimental and practical application strategies. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

Overview

9
9
years of professional experience

Work History

Chemistry Lead

Safetec of America
03.2023 - Current
  • Supervise Chemistry team: Chemist, Chemistry Technicians, Lab Technicians
  • Manage and direct Stability programs/protocols to meet needs of organization
  • Assist in audit inspections as needed
  • Maintain lab equipment including calibration, and preventive maintenance
  • Calculate ingredient amounts for Batch Production Records which require potency adjustments
  • Coordinate release of liquid batches including designation of re-assay/expiration date
  • Assist in sampling, testing and release of raw materials when needed
  • Handles special projects and assignments as delegated (method transfer, method validation)
  • Train lower-level Chemists in use of instruments, methodology, SOPs, TMs, GLP, GMPs, etc.
  • Test raw materials, batches, and finished products in a timely manner
  • Ensure release of raw materials, batches, and finished products are done efficiently
  • Perform review of laboratory notebooks for accuracy and completeness
  • Adequate understanding of requirements of USP and GMP requirements as applied to testing of pharmaceuticals
  • Set up and operate complex laboratory equipment such as HPLC and GC inclusive of any computerized software required for operation of equipment or analysis of results
  • Makes recommendations with respect to cause and resolution of equipment issues or malfunctions
  • Perform chemical testing as needed using TMs, SOPs, and as per methodology USP/NF and other test requirements on raw materials, bulk liquids, and finished products
  • Testing includes but is not limited to: HPLC/GC, IR, UV, wet chemistry Auto-titrator, etc.) for raw materials, bulk liquids, and finished products.

Quality Control Analyst II

Athenex
03.2018 - 03.2023
  • Analytical work in accordance with all applicable Standard Operating Procedures and approved analytical methods
  • Conducts routine laboratory analysis of pharmaceutical raw materials, bulk formulated products, and finished goods
  • Proficient in use of analytical techniques and works independently to perform complex chemical and physical analyses on all products and materials, this includes HPLC instrumentation
  • Provide technical troubleshooting support, knowledge transfer and training/coaching to other junior analysts and laboratory under guidance of Quality Control Management
  • Reduced spending on outside testing facilities by bringing in raw material testing in house
  • Interprets and documents all test results, calculations, observations and completes report summaries
  • Recognized non conforming results and informed management, as well as assisting with Quality Control Management to complete laboratory investigation reports
  • Produces analytical reports, which are accurately documented with procedural integrity for all work performed
  • Ensuring trainees receive appropriate training and information necessary to conduct their activities safely and in a healthy manner
  • Provides technical troubleshooting support, knowledge transfer and training/coaching to other junior analysts and laboratory personnel under guidance of Quality Control Management
  • Promotes and maintains safe, healthy working environment and work area by instructing and enforcing compliance with established safe work practices and procedures
  • Practices current Good Manufacturing Practices (cGMP) in a pharmaceutical laboratory environment
  • Performs general maintenance and calibration of laboratory equipment
  • Responsible for disposing of any waste safely and maintains lab cleanliness
  • Assists in writing of department policies and procedures, develops, and executes new equipment protocols.

Bartender/Server/Manager

Lewiston Event Center
09.2015 - Current
  • Assess customers’ needs and preferences and make recommendations
  • Plan and present bar menu
  • Restock and replenish bar inventory and supplies
  • Stay guest focused and nurture an excellent guest experience
  • Comply with all food and beverage regulations
  • Manage with overseeing party events.

Bartender/Server/Manager

Lewiston Stone House
04.2015 - Current
  • Assess customers’ needs and preferences and make recommendations
  • Plan and present bar menu
  • Restock and replenish bar inventory and supplies
  • Stay guest focused and nurture an excellent guest experience
  • Comply with all food and beverage regulations
  • Manage with overseeing party events.

Education

Bachelors of Science in Biology - Biology

Niagara University
Niagara University, NY
01.2015

Skills

  • Extensive use and knowledge of High-Performance Liquid Chromatography (HPLC), gas chromatography mass spectrometry (GC-MS), Fourier Transform Infrared Spectroscopy (FTIR), Ultra Violet-Visible Spectroscopy (UV-VIS), pH meter, viscometer, autotitrator And various other physical tests
  • Written OOS/OOT investigations, as well as various protocols for new equipment and validations
  • Knowledge of cGMPs, cGLPs, FDA, EU, and USP Guidelines
  • Proficient in Excel, OneDrive, MiniTab, NuGenesis Laboratory Systems, Waters Empower, MasterControl, LabSolutions

Timeline

Chemistry Lead

Safetec of America
03.2023 - Current

Quality Control Analyst II

Athenex
03.2018 - 03.2023

Bartender/Server/Manager

Lewiston Event Center
09.2015 - Current

Bartender/Server/Manager

Lewiston Stone House
04.2015 - Current

Bachelors of Science in Biology - Biology

Niagara University

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Michael Scibilia