MICHAEL MEDLEY
Hickory,NC
Summary
Seeking a Microbiology Laboratory Director position to apply proven leadership skills, technical expertise, and a passion for quality excellence.
Dedicated and results-driven professional with extensive experience in microbiology laboratory management, environmental monitoring, laboratory testing, validation, and regulatory compliance.
Committed to enhancing operational efficiency, maintaining strict adherence to cGMP standards, and fostering a culture of continuous improvement.
Aiming to lead dynamic teams in delivering innovative microbiological solutions that optimize laboratory performance while upholding the highest standards of safety, quality, and regulatory compliance.
Overview
13
13
years of professional experience
Work History
Manager I- Environmental Monitoring/Investigations
Baxter
01.2024 - Current
- Led the Environmental Monitoring (EM) team and Lab Investigation activities, ensuring high performance and compliance.
- Developed and managed key performance indicators (KPIs) and metrics for EM and Lab Investigation teams to track efficiency and quality.
- Ensured routine and qualification samples were collected according to local procedures, global policies, and regulatory expectations.
- Reviewed and approved laboratory investigations related to the Environmental Monitoring program, ensuring thorough documentation and compliance.
- Prepared and coordinated work schedules for the EM and Lab Investigation teams, optimizing resource allocation and productivity.
- Managed the coaching, training, and professional development of team members, fostering a culture of continuous improvement.
Microbiology Manager
Glenmark Pharmaceuticals
12.2022 - 12.2023
- Manage and coordinate testing for microbiology lab team of ten (10) analysts for both environmental monitoring and lab personnel.
- Coach/mentor junior analyst(s) on good laboratory practice and aseptic technique.
- Provide technical leadership over daily lab functions.
- Collaborate with cross functional teams to perform equipment qualifications, write/review protocols and standard operating procedures.
Microbiology Manager/QC Stability
Thermo Fisher Scientific
04.2022 - 11.2022
- Responsible for managing Microbiology and Stability departments managing a total of 14 reports for testing of finished product, raw materials, and process development samples.
- Author microbial limits validation protocol/final reports. Write finished product and raw material microbial limit testing methods. Represent microbiology lab during regulatory, client audits, and EPA audits.
- Validating new equipment in Microbiology Laboratory.
- Management of department testing schedule and inventory budget.
- Oversee Environmental Monitoring program for site.
- Write investigations/CAPAs/Change Controls.
- Collaborate with other departments such as but not limited to operations, planning, and quality for delivery of on time results to clients.
- Initiate and conduct investigations for OOS, deviations, and CAPAs
- Author microbial limits validation protocol/final reports. Write finished product and raw material microbial limit testing methods. Represent microbiology lab during regulatory, client audits, and EPA audits. Validating new equipment in Microbiology Laboratory
Supervisor, Raw Materials/ (Interim Microbiology Team Lead)
Thermo Fisher Scientific
12.2020 - 04.2022
- Responsible for personnel decisions including interviewing, performance evaluations, promotions, development and coaching of staff.
- Oversee team of 7 microbiologists/9 QC Scientist responsible for release testing of raw materials, finished products, stability, and special projects in support of and Oral Solid Dose manufacturing program.
- Initiate and conduct investigations for OOS, deviations, and CAPAs.
- Author microbial limits validation protocol/final reports. Write finished product and raw material microbial limit testing methods. Represent microbiology lab during regulatory, client audits, and EPA audits. Validating new equipment in microbiology laboratory.
QC Analyst II/III- Technical Services
Alkermes
11.2017 - 11.2020
- In charge of all Method Development/Validations of Microbial Enumeration Testing of Raw Materials in the Microbiology Laboratory. Successfully brought in Microbial Enumeration Testing for in house testing.
- Method Development/Validation of Bacterial Endotoxin Kinetic-Chromogenic method LAL testing. Wrote training module for Bacterial Endotoxin used by Product Support Release group. Train new product testing analyst on Microbial Enumeration and Bacterial Endotoxin Testing.
- Testing Method Development/Validation/Optimization for current compendia requirements: USP 85, USP 61, USP
- Support in execution of protocols (i.e. OQ, IQ, PQ), writing protocols/deviations, revising Standard Operation Procedures (SOPs), CAPA, and Change Control. Initial Training for new test method/equipment for product testing analysts.
QC Analyst II-Product Support
Alkermes
02.2016 - 11.2017
- Routine testing of all Finished Product that comes through Microbiology Lab. This includes but is not limited to Bioburden, Endotoxin, and Sterility Testing. Microbial Identification using Vitek 2 Compact, yeast and mold identification.
- Support Technical Service team in bringing new methods for testing products in house. Key skills : Writing investigations Validation of new product methods Assist in Writing/Revising Standard Operating Procedure
Microbiologist II
Piramal Pharma Solutions Formally Coldstream Laboratories Inc.
03.2015 - 02.2016
- Support Operations, Quality Assurance, and Validation in production of sterile parenteral drugs at manufacturing plant
- Carried out Method Developments and Validations for Bacterial Endotoxins Testing (LAL) and Sterility Assurance Validations for new drug products
- Bacterial Endotoxins Testing (LAL) release testing of Raw Materials, Finished Products and Active Pharmaceutical Ingredients
- Product-sample testing to ensure safety, quality and compliance with USP/EU standards
Microbiologist I
Piramal Pharma Solutions Formally Coldstream Laboratories Inc.
05.2012 - 03.2015
- Environmental Monitoring of Clean Rooms and Clean Utility System
- Performed Bioburden, Endotoxin, TOC and Conductivity on water samples.
- Growth promotion testing of incoming Microbiology media.
- Maintain routine lab equipment not limited to: Autoclave, pH meter, conductivity meter, and Vitek 2 Compact.
Education
B.S. - Biology
University of Kentucky
Lexington, KY05-2010
Skills
- Subject Matter Expert in Endotoxin Method Development / Validation
- Cross functional analyst for finished product release testing
- Experience with LIMS Sample Manager
- Experience with Veeva
- Experience with ELN
- Experience with other lab equipment software
- Critical Thinking
- Strategic Planning
- Teamwork
- Time Management
- Staff training and development
- Operations management
Personal Information
Title: Microbiology Manager
Languages
English
Native or Bilingual
Timeline
Manager I- Environmental Monitoring/Investigations
Baxter
01.2024 - Current
Microbiology Manager
Glenmark Pharmaceuticals
12.2022 - 12.2023
Microbiology Manager/QC Stability
Thermo Fisher Scientific
04.2022 - 11.2022
Supervisor, Raw Materials/ (Interim Microbiology Team Lead)
Thermo Fisher Scientific
12.2020 - 04.2022
QC Analyst II/III- Technical Services
Alkermes
11.2017 - 11.2020
QC Analyst II-Product Support
Alkermes
02.2016 - 11.2017
Microbiologist II
Piramal Pharma Solutions Formally Coldstream Laboratories Inc.
03.2015 - 02.2016
Microbiologist I
Piramal Pharma Solutions Formally Coldstream Laboratories Inc.
05.2012 - 03.2015
B.S. - Biology
University of Kentucky
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