CHRISTOPHER BROWN
Somerset,NJ
Summary
A dedicated professional with over 15 years of progressive experience in aseptic manufacturing, specializing in the aseptic fill and finish processes, compounding, and cell therapy. Demonstrated success as a Technical Training Manager, developing comprehensive training programs that enhance skill sets and ensure compliance with industry standards. Proven track record as an Aseptic Core Monitoring Supervisor, effectively overseeing monitoring systems to maintain product integrity and quality in sterile environments. Successfully orchestrated the production of clinical trial materials, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory standards. Experienced in supply chain management, optimizing logistics and inventory processes to support the efficient production of biomedical devices. Leveraging a robust background in aseptic techniques to drive operational excellence, improve team performance, and contribute to advancements in biotechnology and patient care.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Aseptic Manufacturing Sr. Supervisor
PII PHARMACEUTICAL INTERNATIONAL
Hunt Valley, MD
06.2024 - Current
- Provide visionary guidance across all aspects of sterile drug production.
- Implement automation in sterile drug production processes.
- Review production reports and monitor key metrics.
- Develop and execute long-term strategies for facility expansion.
- Oversee daily operations of the Aseptic Compounding and Filling department.
- Supervise and mentor team members.
- Collaborate with Quality Assurance and Control.
- Implement lean manufacturing principles.
- Conduct safety audits and maintain communication with management.
- Increased production efficiency by 20%.
- Reduced contamination rates by 30%.
- Improved on-time delivery rates by 25%.
- Cost reduction in operations through automation.
- Identified areas for process improvement within the department.
- Developed monthly reports detailing progress towards project goals.
- Implemented strategies to improve efficiency within the department.
- Provided leadership and guidance to a team of 25 employees.
Technical Training Manager
MINARIS REGENERATIVE MEDICINE
Allendale, NJ
10.2021 - 01.2024
- Facilitate and conduct on-the-job training for Manufacturing Operations personnel.
- Develop training strategies and monitor training effectiveness.
- Accountable for staffing within Technical Training.
- Champion process improvement initiatives.
- Enhanced trainer effectiveness by 20%.
- Implemented 6S methodology resulting in a 15% increase in operational efficiency.
- Increased training completion rates by 20%.
- Monitored the progress of trainees during their program completion.
- Conducted regular assessments of staff to identify training needs.
- Collaborated with subject matter experts to develop content for courses.
- Ensured that all safety procedures were followed while conducting technical training sessions.
- Implemented innovative approaches to ensure successful outcomes from each class session.
- Prepared reports on performance metrics related to technical training initiatives.
- Developed strategies to promote effective communication within the organization regarding changes in technology or processes related to technical training.
- Researched industry trends and best practices for delivering effective technical training programs.
- Created resources such as handouts, manuals, job aids, videos and other materials to support learning objectives.
- Maintained records on employee participation in training activities.
- Developed and delivered technical training programs for new and existing employees.
- Conducted evaluations of training courses to uncover areas in need of improvement.
- Developed designs, planned curriculum and implemented training courses.
- Analyzed training results to identify needed improvements and adjustments.
- Collected information regarding workflows, procedures and schedules to create job-specific training courses.
Supervisor, Aseptic Core Monitoring
AKORN INC
Somerset, NJ
06.2020 - 10.2021
- Oversee aseptic monitoring for all aspects of aseptic fill processes.
- Develop and implement monitoring protocols.
- Collaborate with cross-functional teams.
- Ensured 100% compliance with aseptic techniques.
- Implemented a comprehensive training program for staff.
- Ensure compliance with aseptic techniques and facility standards to maintain product integrity.
- Train and mentor staff on aseptic processes, procedures, and best practices to enhance their skills and knowledge.
- Monitor and evaluate aseptic core operations to identify areas for improvement and ensure adherence to quality
- Conduct regular environmental monitoring of controlled areas to detect and manage contamination risks effectively.
- Ensure that all activities within the aseptic core meet regulatory requirements and industry standards, including FDA and cGMP.
- Analyze monitoring data and prepare detailed reports on operational performance, trends, and compliance issues.
- Oversee the maintenance and calibration of critical equipment to ensure proper functioning and compliance with standards.
- Investigate any deviations or incidents within the aseptic environment, taking corrective actions and documenting findings.
- Collaborate with Cross-Departmental departments , such as Quality Assurance and Production, to ensure seamless operations and effective communication.
- Contribute to the development and revision of standard operating procedures (SOPs) to enhance aseptic processes and training protocols.
Manufacturing Technical Trainer
NOVARTIS
East Hanover, NJ
08.2018 - 02.2020
- Design and deliver training programs for manufacturing staff.
- Conduct hands-on training sessions and workshops.
- Developed comprehensive training programs.
- Increased employee retention by 20%.
- Established relationships with key stakeholders within the organization to ensure successful implementation of programs.
- Researched new teaching methods to enhance student engagement and learning outcomes.
- Utilized various technologies such as web conferencing software and multimedia tools to deliver high-quality instruction remotely.
- Monitored participant progress by providing individualized coaching and guidance during lessons.
- Provided feedback to trainees on their progress throughout the course.
- Analyzed data gathered from surveys regarding user satisfaction with technical training services provided.
- Maintained records of all instruction activities including attendance rosters, evaluations, tests scores.
- Prepared reports summarizing the success of each program offered by the department.
- Conducted assessments of trainees' skills before and after training sessions to measure effectiveness.
- Designed interactive exercises that allowed learners to practice what they had learned in class.
- Collaborated with other departments to create effective lesson plans that incorporated customer service techniques.
Manufacturing Manager
MUSCULOSKELETAL TRANSPLANT FOUNDATION
Edison, NJ
10.2012 - 08.2018
- Responsible for the day-to-day supervision of aseptic manufacturing operations, including the development, planning, implementation and maintenance of manufacturing methods, processes and operations.
- Led and coordinated daily production activities focusing on safety, quality, productivity, and reliability.
- Managed direct and indirect reports, assessing and adjusting resources to meet business demands effectively.
- Ensured compliance with approved procedures for product production, inspection, storage, and release.
- Provided troubleshooting and problem-solving support on the shop floor.
- Authored, reviewed, and approved GMP documents, including SOPs, Batch Records, and Validation documents.
- Ensured adherence to Good Documentation Practices (GDP) on the shop floor.
- Facilitated GMP training for the production team, ensuring qualifications for required operations.
- Supported compliance activities, including deviations, CAPAs, investigations, and OOS/OOT management.
- Audited emergency paperwork and processes for compliance assurance.
- Collaborated with Production Management on interviewing and hiring production staff.
- Implemented cost control programs to optimize resource utilization.
- Monitored staffing needs to maintain optimum staffing levels aligned with business demands.
Supply Chain Manager
MUSCULOSKELETAL TRANSPLANT FOUNDATION
Edison, NJ
04.2011 - 10.2012
- Oversee the daily operations and effectiveness of Materials Purchasing, Site Manufacturing end-to-end Planning, Value Stream, Global Logistics and Order Management, as well as Warehousing and Aph & Pack activities.
- Develop and implement strategies to optimize the supply chain for efficiency, cost-effectiveness, and sustainability.
- Identify and execute supply chain optimization initiatives aimed at enhancing efficiency, cost savings, and customer service.
- Establish and maintain relationships with suppliers and vendors, negotiating contracts, and ensuring compliance with service level agreements.
- Oversee inventory levels, ensuring adequate stock availability while minimizing excess inventory and associated costs.
- Coordinate transportation and logistics activities to ensure timely and cost-efficient delivery of goods and materials.
- Analyze market trends and demand forecasts to anticipate product needs and align supply chain operations accordingly.
- Identify opportunities for process improvements within the supply chain, implementing best practices and technology solutions to enhance efficiency.
- Cross-Functional Collaboration, work closely with other departments, such as procurement, production, and sales, to ensure alignment and synchronization across the supply chain.
- Develop key performance indicators (KPIs) to measure supply chain performance, analyzing data to identify areas for improvement.
- Risk Management, assess potential risks within the supply chain and develop mitigation strategies to minimize disruptions.
- Manage supply chain budgets and control expenditures to stay within financial targets while optimizing overall performance.
- Identified potential suppliers and negotiated contracts that met the company's needs in terms of pricing, quality, service level agreements.
- Utilized ERP systems to streamline supply chain operations and provide real-time visibility into inventory and order status.
- Ensured compliance with regulatory requirements and industry standards across all supply chain processes.
- Led team development and training initiatives, enhancing supply chain competency and performance.
- Directed logistics operations, including warehousing and transportation, to enhance distribution efficiency.
- Resolved any issues or disputes related to shipments promptly and professionally.
- Communicated regularly with other departments such as sales, marketing and operations regarding supply chain updates.
- Managed the receiving and shipping of all incoming and outgoing orders, ensuring accuracy in product quantity, quality and condition.
- Maintained detailed records of shipments including weight, cost, method of shipment.
- Monitored freight carriers for compliance with safety regulations and company policies.
- Ensured that all customer orders were processed correctly and shipped on time.
- Analyzed customer feedback regarding order processing times to identify areas for improvement.
- Coordinated with carriers to ensure timely delivery of goods.
- Coordinated and monitored inbound and outgoing deliveries, keeping abreast of delays and other issues.
- Maintain a safe workplace while implementing and adhering to policies, procedures, strategies, and global standards.
- Provide guidance, direction, and coordination for supply chain planning efforts that align with global Sales and Operations Planning (S&OP) inventory targets and strategies.
- - Convert corporate objectives into specific functional area goals while creating processes and systems to achieve these targets.
- Establish and monitor key performance metrics related to the health of the Supply Chain organization, driving continuous improvement initiatives.
- Ensure that supply risk management and mitigation strategies are established for identified brands, in line with Global Business Continuity plans and coordination with global, regional, and local stakeholders.
- Assist in the technical transfer of clinical processes for the cell therapy pipeline, including the enrollment of direct materials, creation of bill of materials (BOM), and sourcing of direct materials.
Supply Chain Manager
UNITED STATIONERS
Cranbury, NJ
02.2008 - 04.2011
- Develop and implement strategies to enhance the efficiency and effectiveness of the supply chain operations specific to the distribution of office
- Cultivate strong relationships with suppliers to negotiate favorable pricing, terms, and logistics solutions, ensuring alignment with company goals.
- Manage inventory levels across multiple warehouses to ensure product availability while minimizing carrying costs and stockouts.
- Oversee transportation and distribution logistics to ensure timely and accurate deliveries to customers and distribution.
- Work closely with sales, marketing, and customer service teams to align supply chain activities with customer demand and market trends.
- Analyze sales data and trends to forecast product demand accurately, ensuring optimal stock levels throughout the supply chain.
- Monitor and analyze supply chain performance metrics to identify opportunities for improvement and implement corrective actions as needed.
- Lead continuous improvement projects to streamline supply chain processes, reduce costs, and enhance service levels.
- Identify potential risks in the supply chain and develop mitigation strategies to minimize disruptions and ensure business continuity.
- Ensure compliance with industry standards and regulations, including safety and sustainability practices, throughout the supply chain operations.
- Resolved any issues or disputes related to shipments promptly and professionally.
- Communicated regularly with other departments such as sales, marketing and operations regarding supply chain updates.
- Managed the receiving and shipping of all incoming and outgoing orders, ensuring accuracy in product quantity, quality and condition.
- Planned routes for drivers according to budget constraints and delivery deadlines.
- Monitored freight carriers for compliance with safety regulations and company policies.
- Ensured that all customer orders were processed correctly and shipped on time.
- Analyzed customer feedback regarding order processing times to identify areas for improvement.
Records Center Management
IRON MOUNTAIN
East Brunswick, NJ
02.2005 - 01.2008
- Develop and implement effective records management policies and procedures to ensure compliance with legal and regulatory requirements.
- Build and maintain strong relationships with clients to understand their records management needs and provide tailored solutions.
- Oversee daily operations within the records center, ensuring efficient processing, storage, and retrieval of records.
- Manage and monitor inventory of stored records, ensuring accurate documentation and tracking of all items.
- Ensure the protection of sensitive and confidential information through strict security protocols and access controls.
- Train and mentor employees on records management practices and procedures to enhance productivity and compliance.
- Conduct regular audits to ensure adherence to internal policies, industry standards, and regulatory requirements.
- Leverage technology solutions for efficient records storage, retrieval, and management, including electronic records management systems.
- Develop and implement disaster recovery plans to ensure the safety and accessibility of records in the event of a disaster.
- Identify and implement process improvements to enhance the efficiency and effectiveness of records management operations.
Education
Bachelor of Science - Biology & Chemistry
University of Technology
Kingston, Jamaica05-2001
Diploma - General Studies
Franklin High School
Somerset, NJ06-1997
Skills
- Cell Therapies/ CAR-T
- Aseptic Processing
- cGMP, GDP, GLP, GMP, GTP
- GxP Training
- Sterile Injectables
- Sterile drug production
- Formulation
- Drug inspection
- Aseptic Filling
- CDMO Experienced
- Clean Room Qualified
- Aseptic Technique in ISO Environments
- Contamination control
- Adult education/ Adult learning
- Clean room behavior
- Aseptic gowning qualification
- Biopharma laboratory and/or manufacturing experience
- Document Control Management Operation
- Technical writing
- Batch record review
- Knowledge of FDA and ICH guidelines
- Warehouse Management/ Inventory Management (FIFO)
- Inventory Accuracy and Cycle Count Accuracy
- Cost Center Budget Adherence
- Expired and Obsolete write-offs
- Months On-Hand Inventory versus Safety Stock levels
- Direct Materials Spend Targets and Savings Targets
- Clinical sample management development
- Change Control
- Process Validation Experience
- Process Engineering
- Process Development
- Training program development and implementation
- Budget management and expense tracking
- Regulatory compliance
- Health Authority inspections
- Continuous improvement and strategic planning
- SOP and Work Instruction
- Equipment/instrument qualification experience
- Deviation/CAPA system
- B2B sales experience
- Six Sigma Yellow Belt
- Experience in Biologics
Certification
- Donor Segregation, Verification and Documentation
- Blood borne Pathogens
- Safe Handling and Use of Liquid Nitrogen
- Corporate compliance
- Paperwork and documentation best practices
- Clinical Trial Research
- Safe Handling hazardous waste and chemicals
- Aseptic Processing
- Aseptic fill Finish
- Cell Culture Processing environment
- Quality Control/ Quality risk management
- Six Sigma Yellow Belt Certification, MMD
Learning Management Systems & Quality Management Systems
Veeva Volt, Sharepoint, Master Control, Compliance Wire, Blue Mountain, LIMs, Track Wise, MES, Oracle, microsoft office suite, ERP / SAP system savvy
Timeline
Aseptic Manufacturing Sr. Supervisor
PII PHARMACEUTICAL INTERNATIONAL
06.2024 - Current
Technical Training Manager
MINARIS REGENERATIVE MEDICINE
10.2021 - 01.2024
Supervisor, Aseptic Core Monitoring
AKORN INC
06.2020 - 10.2021
Manufacturing Technical Trainer
NOVARTIS
08.2018 - 02.2020
Manufacturing Manager
MUSCULOSKELETAL TRANSPLANT FOUNDATION
10.2012 - 08.2018
Supply Chain Manager
MUSCULOSKELETAL TRANSPLANT FOUNDATION
04.2011 - 10.2012
Supply Chain Manager
UNITED STATIONERS
02.2008 - 04.2011
Records Center Management
IRON MOUNTAIN
02.2005 - 01.2008
Bachelor of Science - Biology & Chemistry
University of Technology
Diploma - General Studies
Franklin High School