Shevon Walker
Bridgewater,MA
Summary
Results driven CMC Operations leader with expertise in GMP manufacturing, supply chain management and regulatory compliance. Proven track record in enhancing supply chain efficiency and reducing costs by implementing innovative strategies. Skilled in logistics analysis and cross-functional team leadership, demonstrated through successful project completions and continuous improvement initiatives. Excelled in training and mentoring, ensuring team preparedness for regulatory inspection. Adept at integrating product, process and regulatory requirements to enhance operational effectiveness.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Director of Logistics and Supply Chain
OpenBiome
01.2022 - 11.2024
- Managed CMC organization including Fulfillment, Inventory and Supply Chain, Sample Management and Program Management.
- Analyzed performance metrics to identify areas of improvement in the supply chain, leading to measurable success markers.
- Led cross-functional teams to achieve ambitious project goals within time constraints, resulting in successful project completions.
- Streamlined logistics processes by implementing innovative strategies, significantly reducing operational costs.
- Established effective communication channels among team members for improved collaboration and decision making.
- Ensure CMC is prepared for Regulatory Inspections.
- Negotiated favorable contracts with suppliers and carriers, ensuring cost savings without compromising quality or delivery times.
- Assessed risk factors in the supply chain proactively, devising contingency plans to minimize potential disruptions efficiently.
Manufacturing Production Manager
Finch Therapeutics
01.2020 - 01.2022
- Established clear priorities and production quality standards.
- Set and enforced performance-oriented production approach, significantly increasing worker output and reducing safety incidents.
- Prepared in advance for and addressed production problems, material deficits, equipment failures, and unavoidable delays.
- Coordinated with quality control teams to implement corrective actions in response to internal audits or customer complaints, ensuring continuous improvement of products and processes.
- Evaluated team member performance regularly to identify and resolve productivity concerns.
- Authored Standard Operating Procedures (SOPs), event reports, protocols, change controls and CAPAs to improve or remedy current records or process.
- Participated in Talent Acquisition and selecting the interview panel.
Manufacturing Production Supervisor
Finch Therapeutics
04.2018 - 01.2020
- Evaluated and resolved issues quickly to maintain productivity goals.
- Established clear priorities and production quality standards.
- Ensured product quality by closely monitoring production processes, conducting regular inspections, and addressing any issues promptly.
- Managed inventory levels efficiently to ensure availability of raw materials for uninterrupted production runs while avoiding excess stockpiles.
- Trained staff of direct labor employees to perform assembly and manufacture of specified products.
- Improved production efficiency by implementing lean manufacturing processes and reducing waste in the workplace.
- Spearheaded employee development initiatives by conducting regular performance reviews, setting achievable goals, and providing support for professional growth opportunities.
Manufacturing Lead, Senior Manufacturing Associate
Vericel
01.2010 - 04.2018
- Made sure that products were produced on time and are of good quality.
- Worked in a cGMP facility / ISO Class 7 (Class 10,000) Cleanroom, oversaw manufacturing process.
- Performed aseptic manipulations of autologous keratinocyte and chondrocyte cell cultures.
- Performed daily cell observations to determine confluency of flasks and order fill capabilities; recommended and implemented expansions as required to accommodate order requirements.
- Executed internal lab walk-throughs to determine safety, cGMP compliance and SOP standards were adhered to.
- Maintained accurate production records for analysis purposes, ensuring traceability of products throughout the entire manufacturing process.
Education
Biomedical Certificate - Biotechnology
Cambridge Biomedical Careers Program
Cambridge, MASkills
- Training and mentoring
- Logistics analysis
- Warehouse management
- Cross-functional team leadership
Accomplishments
Lead the team during 4 relocations, including personnel, product, equipment and revised supporting documentation.
Worked with a team of Subject Matter Experts (SMEs) to create a new batch record template compatible with all products for use across company.
Revised over 30 SOPs to improve processes and increase productivity.
Certification
- CPR/AED Certification
- [State] Driver's License
- First Aid Certification
Timeline
Director of Logistics and Supply Chain
OpenBiome
01.2022 - 11.2024
Manufacturing Production Manager
Finch Therapeutics
01.2020 - 01.2022
Manufacturing Production Supervisor
Finch Therapeutics
04.2018 - 01.2020
Manufacturing Lead, Senior Manufacturing Associate
Vericel
01.2010 - 04.2018
Biomedical Certificate - Biotechnology
Cambridge Biomedical Careers Program
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