Summary
Overview
Work History
Education
Timeline
Generic

PATRICIA KELLEHER

Summary

Experienced production supervisor familiar with Biotech and medical device operations and best practices. Able to lead and motivate workers to meet challenging targets while maintaining strict quality standards. Adaptable and responsive leader with a decisive and detail-oriented mindset.

Overview

28
28
years of professional experience

Work History

Supervisor Clinical Manufacturing

Moderna
Norwood, MA
04.2021 - Current
  • Leads team of 15 associates for the cGMP manufacture of mRNA medications for evaluation in human clinical trials.
  • Strick adherence to Quality Systems that are consciences of global regulatory expectations
  • Ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized so manufacture mRNA medicines are delivered on time for trials.
  • Responsible for reviewing EBRs and MBRs to ensure rapid disposition of Moderna medicines. Closely partners with QA during all processes.
  • Identifying and documenting any quality events, initiating deviations and conducting investigations to find root cause. Follow through with CAPAs if necessary.
  • Experience with electronic batch records, Syncade, OSI PI, Veeva, and SAP.

Production Supervisor

MilliporeSigma
Danvers, MA
07.2015 - 04.2021
  • Adjusts job assignments and schedules to keep pace with dynamic business needs, factoring in processes, employee knowledge and customer demands.
  • Applies strong leadership talents and problem-solving skills to maintain team efficiency, drives RTF execution and organizes workflow to meet daily demand.
  • Supervises team of over 20 for employee performance, coaching and constructive guidance to address areas of concern.
  • Interviews, hires and trains new temp and perm employees for machine operator and Quality Control positions.
  • Prepares and manages work schedules, vacation and sick time accurately on weekly basis.
  • Utilizes process knowledge and investigation skills to identify and resolve issues and drive continuous improvement in process operations.
  • Practices and promotes safe work habits and adheres to safety procedures and guidelines.

Supervisor Purification

Baxalta, Inc
Milford, MA
02.2015 - 07.2016
  • Directed team of 8 to perform cGMP manufacturing with process knowledge of techniques/specialties for downstream production of Obizur.
  • Coordinate with other departments to resolve issues related to equipment, process, compliance, including maintenance, metrology, and validation.
  • Ensure timely and accurate generation of process documentation.
  • Main troubleshooting/response person.
  • Participated on Continuous Improvement Teams serving in leadership role.
  • Responsible for training and mentoring of newer team members.
  • Used Unicorn, JDE, MS Office, Compliancewire and ISO train programs.
  • Thorough knowledge of laboratory and pharmaceutical production equipment including autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems.
  • Perform work in clean room environment wearing special garments.
  • PPE worn according to safety requirements.

Senior Supervisor

Janssen Biotech, Inc
Malvern, PA
02.2003 - 09.2013
  • Supervised team of 15 direct reports in execution of manufacturing processes according to standard operating procedures performed manufacturing duties as necessary for Remicade production.
  • Acted as primary contact for maintenance, quality groups and support departments.
  • Accurately completed and reviewed documentation in batch records, logbooks and other GMP documents.
  • Actively participated in planning, execution and communication of strategies directed to achieve company goals and objectives.
  • Responsible for coaching and development of direct reports and enforced all company policies.
  • Took necessary disciplinary actions as appropriate in partnership with Human Resource Department.
  • Navigation of SAP, EDOC, MS Office, Delta V, LIMS systems.

Production Supervisor

Max Levy Autograph, Inc
Philadelphia, PA
02.1998 - 02.2003
  • Supervised and trained departmental technicians in all aspects of Photo-lithographic process.
  • Scheduled work flow of standard and repeat orders for department.
  • Operated 2-Dimensional laser interferometer controlled photo-plotter for making high precision large format technical patterning for machine vision, control and calibration applications.

Lab Technician

Morrow Associated Enterprises
Williamstown, NJ
02.1995 - 02.1998
  • Performed and organized various testing procedures, generating data and inputting results into Excel spreadsheets for analyzing.
  • Executed resin and bottle approval process for Pepsi Cola North America and International, as well as quality assurance testing for multiple clients.

Education

B.S - Biology

Rowan University

University of Limerick
Ireland

Timeline

Supervisor Clinical Manufacturing

Moderna
04.2021 - Current

Production Supervisor

MilliporeSigma
07.2015 - 04.2021

Supervisor Purification

Baxalta, Inc
02.2015 - 07.2016

Senior Supervisor

Janssen Biotech, Inc
02.2003 - 09.2013

Production Supervisor

Max Levy Autograph, Inc
02.1998 - 02.2003

Lab Technician

Morrow Associated Enterprises
02.1995 - 02.1998

B.S - Biology

Rowan University

University of Limerick
PATRICIA KELLEHER