Michael Mcerlean

Michael Mcerlean Email and Phone Number

Staff Operations Specialist - Malvern Clinical Operations - J&J Innovative Medicine @ Johnson & Johnson
new brunswick, new jersey, united states
Michael Mcerlean's Location
Greater Philadelphia, United States
Michael Mcerlean's Contact Details

Michael Mcerlean work email

Michael Mcerlean personal email

About Michael Mcerlean

🌱 Biotech Professional | 20+ Years in Pharmaceutical Operations 🌱With over 20 years of experience in biotechnology, I have developed a robust background working with some of the world’s leading pharmaceutical companies. My expertise lies in manufacturing operations, support, continuous improvement, and effective team building. I am passionate about driving efficiency and excellence, consistently delivering significant cost savings through strategic process enhancements.🔑 Key Achievements:Operational Excellence: Spearheaded the mapping and implementation of a revised turnaround schedule for production bioreactors, resulting in an additional 52 production days—translating to over $50 million in annual value.Cost Savings: Led the successful adoption of innovative single-use bioprocess sampling containers, which generated annual savings exceeding $300,000. Additionally, I negotiated a 50% reduction in cleanroom supplies costs, leading to projected annual savings of $150,000.🌟 Leadership & Team Development:I excel at fostering autonomous teams that emphasize decision-making and accountability. Through mentoring individuals on their Improvement/Growth Plans, I have guided many to become integral team members while nurturing their professional development. I thrive in self-directed environments, effectively prioritizing tasks and proactively addressing challenges to maintain manufacturing timelines. My collaborative approach promotes synergy in interdisciplinary teams, allowing us to tackle challenges and seize opportunities together.🔍 Process Improvement & Troubleshooting:I possess strong expertise in diagnosing and resolving complex manufacturing system issues, identifying root causes of deviations, and implementing effective corrective measures. My initiatives focus on mistake-proofing processes, improving overall yields, and embracing Lean methodologies.📈 Project Management:I have successfully managed projects with budgets up to $1M, excelling in soliciting contractor proposals and evaluating optimal teams for execution. I oversee daily construction activities, ensuring adherence to safety standards while monitoring project progress toward successful completion.🚀 Recent Contributions:I recently played a pivotal role in the successful launch of a new Pilot Plant for Johnson & Johnson. Following this project, I supported two additional successful product runs for new Phase 1 Clinical Products. Currently, I lead a dedicated team of Manufacturing Process Specialists, focusing on technical transfers for new Phase 1 Clinical Products.

Michael Mcerlean's Current Company Details
Johnson & Johnson

Johnson & Johnson

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Staff Operations Specialist - Malvern Clinical Operations - J&J Innovative Medicine
new brunswick, new jersey, united states
Website:
jnj.com
Employees:
123077
Michael Mcerlean Work Experience Details
  • Johnson & Johnson
    Staff Manufacturing Process Specialist - Malvern Clinical Operations
    Johnson & Johnson Feb 2023 - Present
    Malvern, Pa
    Clinical Biopharmaceutical Manufacturing
  • The Janssen Pharmaceutical Companies Of Johnson & Johnson
    Staff Manufacturing Process Specialist - Malvern Clinical Operations & External Supply
    The Janssen Pharmaceutical Companies Of Johnson & Johnson Jun 2023 - Jan 2024
    Malvern, Pa
    Key technical subject matter expert in biologics drug substance manufacturing, providing technical support during technology transfer of new product introduction processes and GMP manufacturing operations to ensure the manufacture and delivery of novel drug substance clinical materials per CMC timelines. Contribute to delivering on milestones and goals associated with brining new pilot plant online.
  • The Janssen Pharmaceutical Companies Of Johnson & Johnson
    Staff Operations Specialist - Pilot Plant Project Upstream Operations Lead
    The Janssen Pharmaceutical Companies Of Johnson & Johnson Jun 2022 - Jun 2023
    Malvern, Pennsylvania, United States
    Currently in 'Body of Design' phase for a new project. New single use technologies are being incorporated into existing facility at our Malvern, PA campus, encompassing Cell Culture, DPC &, downstream operations. Single use Bioreactors (SUBs) , Single Use Mixers (SUMs), single use chromatography columns, along with permanent in-line dilution skids & centrifuge equipment.
  • The Janssen Pharmaceutical Companies Of Johnson & Johnson
    Staff Operations Specialist
    The Janssen Pharmaceutical Companies Of Johnson & Johnson Jan 2021 - Jun 2023
    Malvern, Pennsylvania, United States
  • The Janssen Pharmaceutical Companies Of Johnson & Johnson
    Sr. Operations Specialist
    The Janssen Pharmaceutical Companies Of Johnson & Johnson Apr 2019 - Jan 2021
    Malvern, Pennsylvania, United States
  • Depuy Synthes Companies
    Bridges Associate - Package Development Engineer
    Depuy Synthes Companies Apr 2018 - Apr 2019
    West, Chester, Pa
  • Ethicon, Inc.
    Bridges Associate - R&D Engineer - Wound Closure Life Cycle Management
    Ethicon, Inc. Dec 2016 - Mar 2018
    Somerville, Nj
    Selected for Johnson and Johnson's BRIDGES Program consisting of two, one-year rotations within the Johnson and Johnson network of companies.2017 Rotation - Ethicon Inc. - member of the "Wound Closure Life Cycle Management" team working on Ethicon's TVT Abbrevo device as well as new product development of a trocar for use with Ethicon's Blake Drain in the Japanese market.2018 Rotation - To be determined
  • The Janssen Pharmaceutical Companies Of Johnson & Johnson
    Senior Operations Specialist
    The Janssen Pharmaceutical Companies Of Johnson & Johnson Apr 2015 - Dec 2016
    Malvern, Pa
    * Manage external contract cGMP Cleaning and Manufacturing Services team. Hold weekly meetings to remove roadblocks and review assigned tasks; monthly meetings with contractor's site manager & regional V.P. to review metrics and provide feedback.* Execute Change Controls* Manufacturing & Engineering Excellence (ME2): Owner of Chapter 2.5 "Change Over"* Training Within the Industry (TWI)* Lead for Job Safety Analysis Teams for manufacturing
  • The Janssen Pharmaceutical Companies Of Johnson & Johnson
    Manufacturing Process Specialist - Contractor
    The Janssen Pharmaceutical Companies Of Johnson & Johnson Feb 2015 - Apr 2015
    Malvern, Pa
    Utilize TrackWise ETS to generate, track, execute & close Events, Deviations, CAPAs, Change Controls, & ProjectsInvestigate manufacturing events & deviationsExecute Change Controls for Upstream Manufacturing ProcessesDevelop Werum PAS-X (MES) Manufacturing Execution System to track (IPPs) In Process Parameters for Cell Culture and DPC
  • James Brown Hvac
    Field Instillation Technician
    James Brown Hvac Jun 2014 - Feb 2015
    West Chester, Pa
    Instillation of custom Geothermal, Hydronic, Radiant, Unico Cooling, & Energy Recovery SystemsPerform preventative maintenance, troubleshooting, & repair of existing HVAC systemsInteracted with customers to ensure 100% satisfaction, answer questions, & address concernsFirst-Place - 2014 Bosh Clean Living Award - residential category
  • Envera
    Fermentation Manager - Project Manager
    Envera May 2013 - Jun 2014
    West Chester, Pa
    Manage and execute bacterial fermentation (predominately Bacillus strains) for research, agriculture, aquaculture, waste-water treatment, and other industrial uses. Project manager for major capitol expansion project consisting of installing a new 1,500 gallon bioreactor and it's related mechanical equipment (boiler, air compressors and air-drier, chiller and condenser). Pipeline for future project management tasks include the construction of additional manufacturing space, instillation of an industrial sized (two-story) spray-dryer and, installation of additional boiler system.
  • Fibrocell Science
    Logistics Manager And Coordinator
    Fibrocell Science Mar 2012 - Mar 2013
    Exton, Pa
    Responsible for scheduling all incoming biopsies and outgoing injection shipmentsWork directly with vendors to negotiate pricing on raw materials and servicesImplement 6S and Lean methodologies to warehouse and Materials Management activitiesGenerate SOPs, Change Controls, and protocolsClose CAPAs, reduce departmental deviations and improve 'Right the First Time' metrics for the departmentParticipated in a successful FDA audit in Oct2012
  • Merck Sharp & Dohme
    Rotavirus Manufacturing Supervisor
    Merck Sharp & Dohme Aug 2010 - Mar 2012
    West Point, Pa
    Member of the leadership team for Upstream Operations of the RotaTeq vaccine manufacturing process at Merck's West Point, PA site. The RotaTeq Vaccine is a live, oral, pentavalent vaccine that is used to combat the Rotavirus in infants. Worldwide Rotavirus causes ~ 500,000 infant deaths annually primarily in third world countries.Lead teams consisting of 10-16 union technicians, managed union relations and enforced union contracts. Troubleshot process roadblocks and investigated procedural deviations. Utilized lean principles to streamline upstream manufacturing processes. Cell lines scaled up by employing single use container technologies primarily centered around CellSTACK platforms.
  • Centocor
    Cell Culture & Media Coordinator
    Centocor Aug 2008 - Aug 2010
    Malvern, Pa
    Generated Manufacturing Production Plans for Remicade ProductionGenerated schedule scenarios for: The introduction of new products into the current production system w/o interfering with current production metrics The production of required materials for Phase II and Phase III Clinical Trials Scenarios to obtain 1yr, 3yr and, 5yr production goals Manufacturing set-back recovery plansScheduled departmental activities on a daily and per shift levelWorked to maintain a ‘level-loaded’ system
  • Centocor
    Cell Culture Supervisor
    Centocor 2005 - 2008
    Malvern, Pa
    Lead teams in the production of Remicade Worked with team members to help them obtain business and personnel goalsSME in Cell Culture operations and troubleshooting activities of continuous perfusion bioreactorsLead site-wide Safety-Team and rolled out the PAUSE Program – a bottom up approach to safety utilizing peer feedback and positive reinforcement of actions and behaviorsAttended Johnson & Johnson’s ‘Leadership for Managers’ class Participated in FDA, EMEA and, other regulatory inspection agency audits
  • Centocor
    Cell Culture Technician
    Centocor 2002 - 2005
    Malvern, Pa
    Operated, maintained &, utilized (10) 1000L Continuous Profusion Production Bioreactors, (4) 250L Seed Bioreactors for the production of RemicadeRevised SOPs for clarity, mapped SOPs to align with process constraints and manufacturing execution Worked to mistake-proof processes as vulnerabilities were defined, participated in Root Cause Analysis of Human Errors and Mechanical Issues

Michael Mcerlean Skills

Sop Biotechnology Gmp Capa Change Control Validation Biopharmaceuticals Lean Manufacturing Six Sigma 21 Cfr Part 11 Pharmaceutical Industry Vaccines Quality System Aseptic Processing Manufacturing Technology Transfer Cell Culture Process Improvement Lims Cell Life Sciences Root Cause Analysis Aseptic Technique Clinical Trials Fermentation V&v Lifesciences Glp Standard Operating Procedure Laboratory Information Management System 5s Good Laboratory Practice Design Control New Product Development Project Manager

Michael Mcerlean Education Details

Frequently Asked Questions about Michael Mcerlean

What company does Michael Mcerlean work for?

Michael Mcerlean works for Johnson & Johnson

What is Michael Mcerlean's role at the current company?

Michael Mcerlean's current role is Staff Operations Specialist - Malvern Clinical Operations - J&J Innovative Medicine.

What is Michael Mcerlean's email address?

Michael Mcerlean's email address is mc****@****ail.com

What schools did Michael Mcerlean attend?

Michael Mcerlean attended Saint Joseph's University, Millersville University Of Pennsylvania.

What are some of Michael Mcerlean's interests?

Michael Mcerlean has interest in Children, Process Improvementoutside Of Work, Backpacking, Gardening, Problem Solving, Environment, Leadership Development, At Work, Process Improvement Outside Of Work, Process Improvement.

What skills is Michael Mcerlean known for?

Michael Mcerlean has skills like Sop, Biotechnology, Gmp, Capa, Change Control, Validation, Biopharmaceuticals, Lean Manufacturing, Six Sigma, 21 Cfr Part 11, Pharmaceutical Industry, Vaccines.

Who are Michael Mcerlean's colleagues?

Michael Mcerlean's colleagues are Waldenise Paiotti Paiotti, Imelda Netsel, Dana Pomeroy, Leandro Falquete, Sparky Anderson, Darragh Frawley, Rita Kirk.

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