Contact

508-***-****

ad05xt@r.postjobfree.com

Education

**/****

MBA, Fitchburg State University, Fitchburg MA

**/**** ********* ******

These work experiences showcase my expertise in manufacturing supervision, ensuring compliance with regulations and standards, driving continuous improvement initiatives, managing teams, resolving issues, conducting validations, and promoting a culture of safety and quality. I am confident that my skills and experiences make me well-suited for a manufacturing manager position in the biotechnology or pharmaceutical industry, with a focus on quality assurance.

Experience

BS in Biomedical Sciences, Boston University Boston MA

08/2006

Certificate in Biotech, Quinsigamond Community College, Worcester, MA

Professional Summary

Experienced Manufacturing Supervisor with a demonstrated 16+ year history of working in a fast-paced cGMP biotechnology environment, showcasing exceptional leadership and time management skills.

Expertise in single-use technology, small and large-scale cGMP production equipment, and comprehensive knowledge of support services, upstream, and downstream operations.

Proven track record of ensuring compliance and consistently achieving timely completion of work to meet deadlines.

Results-oriented professional with a strong focus on improving safety, production efficiency, and quality standards.

Adept at combining in-depth knowledge of manufacturing processes with the practical application of lean manufacturing principles, 5S management systems, and strategic planning techniques.

3/2022-Present

Manufacturing Supervisor, Sanofi Framingham MA

Maintaining a safe working environment and reporting incidents/accidents to site leadership.

Assigning daily duties and tasks to team members and ensuring execution of manufacturing activities in strict accordance with production batch records, standard operating procedures, and cGMP.

Managing and developing the performance of direct reports by setting clear goals, providing timely feedback, and recognizing high achievers.

Escalating production floor issues related to personnel, safety, procedures, materials, process, equipment, automation, utilities, and/or information systems to Manufacturing management and appropriate functional teams.

Cross-training personnel within multiple departments and providing employee feedback to management.

Scheduling and delivering training to manufacturing personnel to ensure correct, safe, and compliant operations.

Partnering with Manufacturing Managers and Quality to ensure manufacturing areas are inspection ready.

Promoting a "Right First Time" philosophy for all manufacturing activities.

Operating complex systems and equipment in accordance with production batch records, standard operating procedures, and cGMP.

Performing batch record and MES review, supporting site scheduling processes. Ensuring identification and documentation of events that deviate from normal operation, supporting deviation investigations and closure.

Collaborating with Quality Assurance to identify and address deviations, supporting investigations and CAPA closure.

Supporting Manufacturing Operations Manager and Manufacturing Specialist in the investigation, closure, and CAPA implementation for major and critical deviations.

Contributing to the continual improvement of manufacturing documentation (SOPs, MBRs, OJT) to ensure accuracy and clarity.

Managing and supporting floor continuous improvement initiatives and representing Manufacturing in Project Team meetings; may lead department initiatives and projects.

Participating in the validation of production equipment and processes. Leading MDI/DCM/QCDI meetings and shift handovers.

6/2021-03/2022

Manufacturing Supervisor Anika Therapeutics Bedford MA

Demonstrated expertise in production, encompassing inventory management, safety protocols, quality improvement initiatives, operations management, scheduling, and preventative maintenance.

Collaborated closely with the QA team to identify non-conformances and deviations, initiating and closing non-conformance reports while conducting thorough root cause investigations.

Implemented a comprehensive scorecard system to effectively track and monitor weekly and monthly manufacturing activities, enabling data- driven decision-making and process improvements.

Developed and implemented a production scheduling system that incorporated periodic cost forecasting, optimizing resource allocation and production efficiency.

Drove continuous improvement efforts across safety practices, quality standards, compliance, 5S methodology, and on-time delivery, fostering a culture of excellence.

Evaluated employee performance against pre-established standards and provided coaching and counseling to promote professional growth and achieve short and long-term goals.

Maintained a safe work environment by ensuring strict process adherence and actively identifying and mitigating potential hazards.

5/2020-06/2021

Manufacturing Supervisor, FUJIFILM Biotechnologies College Station TX

Led and managed floor activities to drive continuous improvement initiatives, promoting a high level of morale and teamwork through frequent communication and collaboration.

Operated production systems and equipment in strict accordance with production records, standard operating procedures, and cGMP guidelines, ensuring compliance and optimal performance.

Played a key role in leading deviation resolution and closure processes by collaborating with subject matter experts and quality teams. Provided valuable input and support to Research and Development functions during development and scale-up activities, leveraging manufacturing insights to optimize processes and ensure successful product outcomes.

Supervised daily manufacturing activities and staff, overseeing hiring, performance evaluations, coaching, and training to enhance team capabilities and productivity.

Implemented project-specific safety and quality assurance programs to ensure adherence to regulatory standards and industry best practices.

05/2018-2020

Manufacturing Supervisor, Brammer Bio/ThermoFisher Cambridge MA

Demonstrated expertise in effectively resolving and escalating floor issues related to safety, procedures, materials, and equipment, ensuring a safe and efficient working environment.

Conducted process and equipment validation runs for new clients' processes, ensuring compliance with regulatory requirements and driving successful project outcomes.

Implemented PPI-5 methodologies to drive process improvements, enhance operational efficiency, and optimize resource utilization.

Led cross-functional teams through problem-solving processes, effectively documenting issues and identifying innovative solutions to prevent recurrence.

Scheduled and delivered training programs to manufacturing personnel, emphasizing the importance of safety standards while enhancing skill sets.

Performed engineer runs and facilitated clinical trials for different clients, showcasing the ability to adapt to diverse project requirements. Coordinated and organized daily operations, ensuring smooth workflow and timely project completion.

Collaborated with cross-functional continuous improvement teams to drive operational excellence and implement best practices.

8/2012-05/2018

Manufacturing Supervisor, Genzyme Framingham MA

Maintained a safe working environment and reported incidents/accidents to site leadership.

Assigned daily duties and tasks to team members and ensured execution of manufacturing activities in strict accordance with production batch records, standard operating procedures, and cGMP.

Managed and developed the performance of direct reports by setting clear goals, providing timely feedback, and recognizing high achievers.

Escalated production floor issues related to personnel, safety, procedures, materials, process, equipment, automation, utilities, and/or information systems to Manufacturing management and appropriate functional teams.

Cross-trained personnel within multiple departments and provided employee feedback to management.

Scheduled and delivered training to manufacturing personnel in accordance with the Department Training Plan to ensure staff can perform manufacturing operations correctly, safely, and compliantly.

Partnered with Manufacturing Managers and Quality to ensure manufacturing areas were inspection ready. Promoted a "Right First Time" philosophy for all manufacturing activities.

Operated complex systems and equipment in accordance with production batch records, standard operating procedures, and cGMP. Supported Manufacturing Operations Manager and Manufacturing Specialist in the investigation, closure, and CAPA implementation for major and critical manufacturing-owned deviations.

Contributed to the continual improvement of all manufacturing documentation (SOPs, MBRs, OJT) to ensure they were current, accurate, and clear.

Participated in the validation of production equipment and processes. Led MDI/DCM/QCDI meetings and shift handovers.

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