Stacy Lucas

Newtown, PA

215-***-****

adxexy@r.postjobfree.com

EXPERIENCE:

Endo Pharmaceuticals

Horsham, PA

Senior Manufacturing Specialist November2021-January 2023

Authors, revises and reviews manufacturing and process equipment documentation

Authors investigation documentation and participates in/resolves manufacturing production events/non-conformances in timely manner

Creates and/or completes CAPA(s) resulting from manufacturing events

Author and implement change requests to support changes to processing, batch records, and equipment, particularly scale-up processing, and process improvement

Authors/implements change controls associated with continuous improvement and supports equipment, process, and utilities.

Assist with CCH process scale-up, development activities, new suite development and technology transfer projects

Identify and support continuous improvement initiatives: Engages with supervisors and managers to optimize the manufacturing process

Facilitate the upkeep of fermentation/purification owned equipment. Resolve equipment issues with engineering/facilities and contact vendors as needed.

Works with Validation and leads process, equipment, and cleaning validation initiatives within the GMP facility as needed

Supports validation efforts associated with manufacturing equipment and processes

Reviews batch records and logbooks

Provide guidance and training to manufacturing specialists and other manufacturing associates

Works in a hands-on capacity in the cGMP fermentation/purification and production support areas to manufacture collagenase clostridium histolyticum bulk drug substance (CCH BDS)

Performs and supports fermentation/purification process scale-up and all manufacturing production activities

Successfully completed FAT (Factory Acceptance Test) and SAT (Site Acceptance Test) for Facility Equipment for scale-up for second suite

Performs engineering activities to ensure equipment functions to specifications for scale-up process including all CIPs and SIPs

Ensures work is completed in compliance with approved SOPs, batch records and controlled documentation and all applicable regulations, guidelines, safety policies and procedures are followed

Provides timely technical input to support ongoing operations

Assist in troubleshooting processes and equipment within the cGMP facility

Assists manufacturing leaders for inspection-readiness at all times

Performs GEMBA walk thru montly

Aha! Leadership Training Certified

Supervisor- Upstream August 2020-Nov-2021

Supervises team in hands-on capacity during GMP operations and authors daily production schedules and assists with all production activities.

Provides timely technical input to support on-going operations and resolve manufacturing deviations/non- conformances.

Troubleshoots processes and equipment within the GMP facility and performs documentation closeout activities to release processes and equipment for production as required.

Supervises fermentation process scale-up or development activities as needed.

Qualified Trainer on all Upstream Manufacturing Processes and SOPs

Author shutdown schedules and ensure tasks are done on time and within compliance.

Authors deviations and implements change controls and CAPAs associated with and support equipment, processes, and utilities.

Authors, revises, and reviews manufacturing equipment, facility and utility documentation, including but not limited to: SOPs, forms, master batch records, and protocols.

Executes protocols for process equipment and /or validation

Assist QA, as required, with internal and external audits.

Ensures manufacturing operations are established and maintained in compliance with all applicable regulations, guidelines and safety policies and procedures.

Extensive knowledge of fermentation / upstream processing and equipment, and SAP

Keeps track of all Upstream inventory

Frequent user of Coupa, Blue Mountain Regulatory (CAMS), Trackwise, and MasterControl systems

Manufacturing Lead - Upstream March 2019-August 2020

Leads manufacturing production activities to operate fermenters, perform seed scale-up, sterilize equipment, prepare media solutions, and clean equipment.

Leads development, validation, and process improvement efforts and authors/implements change controls associated with fermentation and support equipment, processes, and utilities.

Provides timely technical input to support ongoing operations.

Works with cross-functional teams and leads process, equipment and cleaning validation initiatives within the GMP facility.

Identifies and supports continuous improvement initiatives.

Authors investigation documentation and participates/resolves manufacturing deviations/non-conformances.

Troubleshoots processes and equipment and leads process, sterilization, and cleaning validation initiatives.

Acts as qualified trainer for SOPs and procedures.

Trains Manufacturing Associates of all levels.

Advanced knowledge of cGMP practices, ICH guidelines, validation practices.

Technical expert in fermentation / upstream processing.

Advanced knowledge of automated or semi-automated fermenters, bioreactors, holding tanks, aseptic operations, seed scale-up, harvest equipment, and cleaning and sterilization procedures for biopharmaceutical products.

Advanced knowledge of process validation practices for biopharmaceutical products and can author and lead process validation protocols and efforts.

Manufacturing Associate II – Upstream April 2015-March 2019

Perform daily fermentation steps of cGMP manufacture of Collagenase Clostridium Histolyticum (CCH) bulk drug substance (BDS).

Work in hands-on capacity to operate fermenters (SIPs, CIPs), media preparation vessels, holding tanks, prepare media solutions, perform seed scale-up, sterilize (autoclave) and clean process equipment (washers).

Lead process, equipment, and cleaning validation initiatives. Gather group to communicate daily tasks and weekly work.

Assist with development work as needed.

Author and revise manufacturing and process equipment documentation as necessary.

Assist in the resolution of manufacturing deviations/non-conformances. Assist with troubleshooting processes and equipment.

Keep track of results for validation spreadsheets.

Performance trainer for all Manufacturing Activities as well as Aseptic Qualification Trainer

Order Logbooks, Batch records, and Media Forms.

Stock gowning for the Manufacturing facility.

Order materials and keep track of inventory for Upstream/Manufacturing.

Ensure work is completed in compliance with:

oApproved SOPs, Batch records, Controlled documentation

oAll applicable regulations, guidelines, safety policies and ensuring procedures are followed.

Manufacturing Associate I – Upstream April 2010-April 2015

Perform daily fermentation steps of cGMP manufacture of Collagenase Clostridium Histolyticum (CCH) bulk drug substance (BDS).

Work in hands-on capacity to operate fermenters (SIPs, CIPs), media preparation vessels, holding tanks, prepare media solutions, perform seed scale-up, sterilize (autoclave) and clean process equipment (washers).

Lead process, equipment, and cleaning validation initiatives. Gather group to communicate daily tasks and weekly work.

Assist with development work as needed.

Revise manufacturing and process equipment documentation as necessary.

Assist in the resolution of manufacturing deviations/non-conformances. Assist with troubleshooting processes and equipment.

Keep track of results for validation spreadsheets.

Order Logbooks, Batch records, and Media Forms.

Stock gowning for the Manufacturing facility.

Order materials and keep track of inventory for Upstream/Manufacturing.

Ensure work is completed in compliance with:

oApproved SOPs, Batch records, Controlled documentation

oAll applicable regulations, guidelines, safety policies and ensuring procedures are followed.

MedImmune, LLC Philadelphia, PA

Pharmaceutical Technical Specialist 1 July 2009-April 2010

Manufacture Flumist and H1N1 Vaccines: procedures including:

oThawing of product, stage, Environmental Monitoring (EM)(Personnel Plating), Aseptic Manufacturing Techniques, Controlled Facility Cleaning of Class 100- 10,000, Gowning Qualified of Controlled Areas, QC Responsibilities, Working with cGMP’s and SOP’s, Review and Edit SOP’s, Evaluation of Media Sprayers for Media Fills, Materials Transfer

oExperience with Computer Software:

MODA (Entering Data, Approver of Collected Data), Aegis, LMS, LIMS

EDUCATION:

TEMPLE UNIVERSITY, Philadelphia, PA January 2009

Bachelor of Arts Major: Human Biology

BUCKS COUNTY COMMUNITY COLLEGE, Newtown, PA May 2002

Associate of Arts

Major: Liberal Arts and Sciences References available upon request

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