Associate Development Operations Supervisor
Resume:
*********@*****.***
Tracy L. Sanders
Objective: To obtain a position where I can apply my knowledge and Leadership skills that I’ve learned in the pharmaceutical divisions to advance my career and the industry of Pharmaceutical/Biotechnology Processing.
Work History:
2024 _ Guerbet Raleigh NC
Operations Supervisor/Packaging
•Manage 15 direct reports.
•Responsible for Annual Performance Reviews.
•Responsible for Weekly Timesheet approvals.
•Responsible for Mfg. Associate Development Plans.
•Facilitate Tier meetings.
•Responsible for scheduling daily work activities.
•Imitating deviations/investigations.
•Regulate GMP training compliance of Direct Reports.
•SAP data entries.
•Facilitate company safety meetings.
•Lead company Audits.
•Responsible for Mfg. Associate Development Plans.
•Review Batch records.
2023 – Current, Fresenius Kabi. Wilson NC
Project/Filling Supervisor
• Managing 21 direct reports
•Responsible for Annual Performance Reviews.
•Responsible for Weekly Timesheet approvals.
•Responsible for Mfg. Associate Development Plans.
•Schedule validation protocol testing of Fill line equipment/Sterilizers.
• Visual inspections.
•Initiating Investigating Deviations to closure.
•Coordinate PM and calibrations for process equipment.
•Responsible for Job Instructions/SOP Redlining and Drafts.
•Facilitate board meeting for Manufacturing/Validation.
2021- 2023 Medicago, USA, Inc. Durham NC
Sr. Supervisor Downstream Operations
•Responsible for Weekly Timesheet approvals
•Responsible for Annual Performance Reviews
•Responsible for Mfg. Associate Development Plans
•Hands on/Lead Trainer for Daily TFF/ Chromatography Operations
•Assignment of daily Operations/ Scheduling personnel workflow
•Communicate daily production progress and escalate process needs.
•Responsible for ensuring Mfg. Associates are operating in a safe working environment.
•SME/Trouble shooting of all DSP processing.
•Responsible for initiating Investigating Deviations to closure.
2020-2021 KBI Biopharma, Durham NC
Downstream Mfg. Supervisor/Duties
•Supervisor of shift of 8 to 10 Mfg. Associates
•Responsible for Weekly Timesheet approvals
•Responsible for Annual Performance Reviews
•Responsible for Mfg. Associate Development Plans
•Assigned to Departmental Hiring Interview Board
•SME/Lead Trainer for Daily Chromatography Column Operations
•Lead/Assignment of daily Operations/ Scheduling personnel workflow
•Communicate daily production progress and escalate process needs.
•Responsible for ensuring Mfg. Associates are operating in a safe working environment.
•SME/Trouble shooting of all DSP processing.
•Responsible for initiating Triage/Investigating Deviations to closure.
•ASCTrac system Super User
•Batch Record Closures
•Directly handled Client consultation
•Responsible for assigning on boarding training.
•Responsible for required current training for GMP operations.
•Coordinate PM and calibrations for process equipment.
•Approve and Assign Qualified Trainers.
2018 – 2020 Novo Nordisk DAPI-US
Manufacturing Associate III-SME/Duties
•FAT of Process equipment for startup facility.
•Responsible for training of Chromatography Column Operations.
•Operation of Delta V/MES.
•Responsible for Job Instructions/SOP Redlining and Drafts.
•EBT for Recovery Processing.
•SDDC review and data entry /Adobe DC Pro/Excel.
•Knowledgeable in all Recovery Upstream Operations.
•Assigned CIP Validation for startup facility.
•Swab sampling/Riboflavin testing.
2015 – 2018 KBI Biopharma, Durham NC
Sr. II Manufacturing Associate-Lead/Duties
•SME/Trainer of BPG/AXI Chromatography Columns
•SME/Trainer of UF/DF, Pods, Planova and Virasol setup/operations.
•Trainer and Operation of AKTA Ready Skids.
•Packing/CIP/Assembly and Evaluation of columns.
•Trainer for Operation of the Unicorn system.
•Prep of process solution buffers.
•Aseptic Operator for Bulk Fills.
•Requesting of Batch Records/Logbooks and consumables for Operations.
•Trainer and Operator for Autoclave operations.
•Train Associates on day-to-day Downstream processing.
•Directly handled Client consultation.
•Responsible for initiating Triage/Investigating Deviations to closure.
2010– 2015 Novartis Vaccines, Holly Spring NC
Lead/Manufacturing Associate III/Duties
•Knowledgeable of Upstream Cell Culture Operations and processing
•Train Mfg. Associates and new Department Equipment Specialist
•Regulate workflow on daily basis.
•Operations of Delta V systems
•Trainer and Operating of Chromatography Dilution Skids
•Trainer and Operating of UFDF Skids
•Commissioning and Validation of new process equipment for startup facility
•Autoclave/Parts washer/Millipore Integrity testing operations.
•SIP/CIP and Pressure Testing Swabbing/Riboflavin testing of Bioreactors and equipment.
•Redline Batch records/create and revise Logbooks/initiate workflows in Atlas.
•Responsible for initiating Triage/Investigating Deviations to closure.
2006– 2010 Diosynth/Shering-Plough, Morrisville NC
Lead Manufacturing Associate II/Duties
•Train Mfg. Associate and new employees.
•Operations of Chromatography Skids and Columns, CM Sepharose/DEAE/Phenyl.
•Operations of Unicorn HETP/ASYMMETRY Evaluations.
•Packing/Unpacking Chroma columns.
•Trainer and Operating of UFDF Skids.
•Aseptic Operator for Bulk Fills.
•SIP/CIP of equipment.
•Swab sampling/riboflavin testing.
•Responsible for initiating Triage/Investigating Deviations to closure.
•Review Batch records.
1999– 2006 Talecris Biotherapeutics Clayton NC
Senior Tech Associate I/Duties
•Train associate and new employees.
•Operations of Chromatography Skids and Columns, CM Sepharose/DEAE/Phenyl.
•Operations of Unicorn HETP/ASYMMETRY Evaluations.
•Packing/Unpacking Chroma columns.
•Operations of UFDF Skids.
•SIP/CIP of equipment.
•DRs/CAPAs.
•Review Batch records.
•Fractionate IV – 1 Cell Paste.
Awards/Certifications
•Operator on the Spot Award
• Grow Management Program/Novo Nordisk
•Advance Upstream/Downstream API/ NC State B-Tech
•Aseptic procedure/BDS Operation/ JCC
•BIO Process Technician Certification/ JCC
•Technical writing Certification/ JCC
•BIO Works Certification/ JCC
•Millipore Certification in Tangential flow filtration/ Wake Tech
•Validation/Verification Certification/ NC State B-Tech
Technical Skills
•Operations/Troubleshooting of TFF systems/Millipore/Pal depth filtration
•Operations/troubleshooting of Vira sol filtration/Planova filtration
•Certification in Aseptic Sampling/Ribo flavin testing.
•Certification in Aseptic Bulk final fill/Class A Cleanroom
•Certification in Upstream/Downstream API processing
•Setup/Operations of process AKTA ready chromatography Systems
•File Setup/Operations of Unicorn software.
•Chromatography Column Packing
•Chromatography/Protein separation
•HMI/IBFM/RCO/PT trouble shooting.
•AsTrac systems
•SDDC (Software-defined data center)
Education 1986 – 1988 Smithfield Selma High, Smithfield NC
Summary
I feel as though I would be a great asset to this company because I have great drive, focus on Quality and determination. Most of all Integrity and I Care about the work that I perform and the Customers I provide for.
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