Ambitious professional seeking a new opportunity to effectively enhance business knowledge and receive the opportunity for career growth and leadership development.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Lead Associate-Fill/Finish Operations
Lilly
Indianapolis
08.2024 - Current
Assisting the Process Team Leaders with leading the Process Teams, specifically focusing on safety, quality, and manufacturing performance using appropriate performance metrics and targets.
Support APS recovery activities
Provide support for inspection readiness
Support and maintain a safety-first culture emphasizing individual accountability, safe systems of work, and management commitment.
in the absence of the Associate Director-Manufacturing provide continuity to the Process Team activities and operational aspects of the process; escalate issues to the Senior Director of Manufacturing Operations as needed.
Lead or participate in continuous improvement projects.
Lead Manufacturing Projects with the support of cross-functional stakeholders.
Support area document revision
Review technical reports.
Conduct deviation investigations and write process deviation reports.
Support Associate Director by compiling weekly, monthly and quarterly metrics
Support area by managing BSAFE program and collaborating with HSE
Provide mentorship to operetors
Formulation Manufacturing Supervisor
THERMO FISHER SCIENTIFIC
St. Louis
09.2021 - 08.2024
Active management of multishift biopharmaceutical/formulation technicians working with clinical and commercial biologics.
Responsible for carrying out functions related to large scale upstream cell culture and downstream chromatography/purification.
Execute production protocols, develop production schedules, and troubleshoot process anomalies.
Serve as area SME during regulatory audits.
Develop high performing teams by recruiting, onboarding, and retaining new talent.
Collaborate daily with cross-functional departments (QA, QC, Buffer Prep, Supply Chain, Engineering, Validation, Regulatory) to meet operational needs.
Manage resource allocation and prioritize production schedule to meet the needs of CDMO clients.
Participate in the implementation of new technologies while inspiring innovation and appropriate change to drive continuous improvement.
Identify and participate in deviation investigations /root cause analysis that arise during GMP manufacturing operations; identify and implement effective CAPAs to prevent recurrence.
Review manufacturing batch records and assist with reconciliation for timely batch disposition.
Turnaround Project Coordinator
PHILLIPS 66
Roxana
09.2019 - 09.2021
Developed work scope items for 40-million-dollar Alkylation Unit capital improvement project.
Prepared detailed plans for equipment isolation and lock out/tag out.
Reviewed and selected bids from third party contractors within the project budget.
Developed unit start up, shut down, and chemical decontamination procedures.
Worked on the CQV of new STRACO Reactor Systems.
Perform JSA and PHA with operations and construction maintenance contractors to ensure understanding of all safety and environmental requirements.
Trained junior operations personnel on project work scope and procedures.
Managed 12 field operators and as many as 75 maintenance contractors daily.
Developed confined space and rescue plans for vessel entries.
Supervised project through delivery by prioritizing needs and delegating assignments amongst operations and maintenance personnel.
Liaised between departments to facilitate communication and keep appropriate parties updated on project developments.
Completed project with 2000+ man-hours without lost time injury.
Process Operating Engineer
Phillips 66
Roxana
04.2013 - 09.2021
Optimized the alkylation, benzene extraction/reduction, and ultra-low sulfur diesel processing units to meet company quality and cost saving initiatives.
Served as SME and trainer for sulfuric acid alkylation unit.
Analyzed and manipulated reactor and distillation column temperatures, pressures, reaction feed rates, and other process variables to maintain desired fuel specifications.
Utilized DCS for remote operation of chemical process from central control center.
Improved daily alkylate production rate 30% by modifying overhead condensing system.
Worked in collaboration with senior process engineering professionals to develop and implement complex process improvements.
Performed routine laboratory sampling and testing (pH, Reid Vapor Pressure, BP, TOC, Karl Fischer, Conductivity, Calcium Hardness, GC, FTIR etc.…)
Performed EPA regulated water sampling and testing.
Utilized P&IDs & PFDs daily to aid in process maintenance and equipment isolation.
Issued safe work permits to contractors and maintenance personnel.
Provided operational support for the commissioning and startup of an ultra-low sulfur diesel hydrogen process unit.
Worked with Turnaround Project Group to complete 10-million-dollar SR DIB capital project.
Worked with Turnaround Project Group on the conversion of ultra-low sulfur diesel hydrogen process unit to FCC slurry hydrogen treater.
Served as a member of the refinery joint health and safety committee.
Quality Tech II
MALLINCKRODT PHARMACEUTICALS
St. Louis
01.2012 - 04.2013
Performed sampling and wet analytical laboratory testing of raw materials, intermediates, and finished products.
Executed FTIR, NIR, GC, and Karl Fischer analysis.
Evaluated results against design standards and compliance requirements.
Decreased site stability sampling backlog by 50% in less than one year.
Performed laboratory calculations and documented results as needed into LIMS.
Made recommendations on ways to improve testing procedures, production processes, and training.
Determined root cause of deviations and non-conforming results and implemented appropriate corrective/preventive actions throughout product development process.
Pharmaceutical Operator
MALLINCKRODT PHARMACEUTICALS
St. Louis
07.2010 - 01.2012
Assisted in the launch of new oral solid dosage drug treatment.
Screened and dispensed raw materials and APIs for bulk manufacturing.
Blended product components and utilized Fette Press for tablet compression.
Performed in-process tablet hardness, thickness, and friability testing.
Modified controls to regulate temperature, pressure, feed, and flow while monitoring outcomes and promoting successful processing.
Performed batch record calculations and maintained all documentation according to CGMP guidelines.
Identified equipment malfunctions and repair needs; troubleshot and/or communicated appropriately for timely resolution.
Performed cleaning, sanitation, and inspection of equipment and processing rooms between production in clean room environment.
Set-up primary, blister pack, and secondary, carton, packaging equipment for finished products.
Trained new employees on production process and expectations.
Served as a member of the site Emergency Medical Response Team.
Education
Bachelor of Liberal Studies - Chemistry/Communications
UNIVERSITY of MISSOURI ST. LOUIS
St Louis, MO
Skills
Detail Oriented
Regulatory compliance
Microsoft Office
Multitasking
Cross-Functional Collaboration
Developing High Performing Teams
Familiar with FDA, EMA, DEA, EPA, and OSHA Regulations
Good Manufacturing/Lab Practices (GMP/GLP)
Interpersonal Skills
New Project Planning and Implementation
Aseptic/Clean Room Practices
Machine and Process Troubleshooting
Experience with PI, APC, DCS, SAP, Trackwise, and Workday
Safety management
Cross-functional collaboration
Resource allocation
Interpersonal communication
Process optimization
Certification
OSHA 30
Hazwoper
Management Essentials
Developing Front Line Leaders
Bio-manufacturing Research and Technical Training
Project Management Professional PMP (in progress)
Timeline
Lead Associate-Fill/Finish Operations
Lilly
08.2024 - Current
Formulation Manufacturing Supervisor
THERMO FISHER SCIENTIFIC
09.2021 - 08.2024
Turnaround Project Coordinator
PHILLIPS 66
09.2019 - 09.2021
Process Operating Engineer
Phillips 66
04.2013 - 09.2021
Quality Tech II
MALLINCKRODT PHARMACEUTICALS
01.2012 - 04.2013
Pharmaceutical Operator
MALLINCKRODT PHARMACEUTICALS
07.2010 - 01.2012
Bachelor of Liberal Studies - Chemistry/Communications