Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Chimere Walker

Indianapolis

Summary

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

UNIVERSITY of MISSOURI ST. LOUIS
Chimere Walker