Director of Manufacturing Operations Resume

Candidate Pitch:

Results-driven, strategic senior executive with extensive experience in manufacturing operations, change management, and business development within the pharmaceutical industry. Adept at optimizing production processes, enhancing operational efficiency, and delivering high-quality products while ensuring compliance with regulatory standards. LINDEN – HENDERSON, NV Director/Plant Manager February 2022−August 2024  Provided oversight to business operations which involve developing performance goals and functions as well as motivating managers to achieve these goals  Collaborated with management to prioritize departmental schedules and agendas, as well as with department managers to maintain efficient operations across all departments  Spearheaded all manufacturing projects, while focusing on timely attainment of production targets and adherence to budget constraints  Organized production activities schedules, allocate resources, and support internal audits  Supervised and guided a team in a fast-paced and demanding environment, including developing career plans for direct reports and resolving issues  Facilitated organizational strategy planning in collaboration with the Corporate Office  Revised and improved processes and policies to align with organizational goals by formulating and implementing departmental and organizational procedures to maximize output  Prepared and set equipment and maintenance schedules to maximize efficiency and minimize downtime  Took part in human resources, finance, and IT management, while fostering an environment of trust, diversity, and inclusion within the organization WOODSTOCK STERILE SOLUTIONS (FORMERLY CATALENT), WOODSTOCK, IL (2002–2022) Operations Manager January 2019−January 2022  Rendered strategic management to the daily operations including manufacturing of pharmaceutical products in adherence to applicable quality standards and delivery requirements  Built a high-performing team to efficiently manage all assign responsibilities  Drove high operational quality across the entire Manufacturing Team, while resolving equipment issues through close collaboration with maintenance personnel  Managed investigations and corrective actions of all production deviations and non-conformances  Presented weekly production summary report to Senior Leadership Team for Corporate Business Unit review  Set expectations and provided feedback and career development support to direct reports Aseptic Assistant Manager June 2017−January 2019  Prepared production and maintenance schedule for multi-shift operations  Assessed and ensured timely delivery of product through planning, execution, documentation, and batch record review stages  Utilized strong communication skills in providing manufacturing representation during the Federal Drug Administration (FDA) and customer audits and tours  Contributed in the improvement of quality performance and on-time delivery to meet customer satisfaction  Acted as the representative of Manufacturing Team during interdepartmental production critical meetings  Analyzed and developed product documentation including protocols, procedures, and job aids to support the manufacturing process  Planned and executed 5s and Lean manufacturing in production suites  Allocated adequate staffing to complete product delivery requirements such as management of labor costs Aseptic Supervisor April 2015−June 2017  Created schedule for aseptic maintenance and production activities  Coordinated maintenance work orders and setups for production changes using JD Edwards  Generated and presented daily status reports on aseptic and maintenance work  Conducted semi-annual and annual reviews in all direct reports  Participated in overseeing progress and establishing performance objectives and development plans  Utilized Kronos in monitoring employee attendance and paid time off (PTO) Key Highlight  Led initiatives to boost production yields and reduce scrap during manufacturing Production Supervisor February 2011–April 2015  Assumed responsibility for interviewing, hiring, and training over 80 employees in the Blow Fill Seal (BFS) aseptic fill of liquid drugs and packaging  Oversaw technical reviews, deviation investigation, and Corrective Action Preventative Actions (CAPAs) implementation, and provided manufacturing ideas for the integration and validation of new equipment and process including serialization  Directed the group through change management with primary focus on process efficiency improvement to create quality product in a safe and current good manufacturing practices (cGMP) compliant environment  Maintained strict compliance of operators and packaging staff with batch records and relevant standards operating procedures (SOPs)  Monitored adherence of the facility and processes to Occupational Safety and Health Administration (OSHA) guidelines and environment, health, and safety (EHS) policies  Strategized and executed appropriate protocols to efficiently manage contingent workforce through third- party staffing agencies  Performed weekly audits on manufacturing floor for potential safety hazards  Addressed and resolved conflicts of company policies and cGMP  Delivered production updates to the managers and supervisors of other departments  Took charge of coordinating pilot program for deviation management excellence Technical Lead August 2009–February 2011 Manufacturing Technician August 2002–August 2009  Managed scheduling, safety protocols, and ensured the quality and timely production of all products during the assigned shift  Led daily shift debriefs with lead technicians from the opposite shift to ensure smooth operations and seamless handoffs  Oversaw and maintained a thorough understanding of all technical aspects of both aseptic and terminal sterilization processes  Acquired extensive knowledge and hands-on experience in batch formulation and aseptic liquid processing using Blow/Fill/Seal (BFS) technology  Trained new employees on the operation of equipment, adherence to standard operating procedures (SOPs), and compliance with safety guidelines in a pharmaceutical manufacturing environment  Accurately completed and managed documentation for complex, multi-step pharmaceutical manufacturing processes  Gained expertise in troubleshooting large-scale manufacturing equipment and Water for Injection (WFI) systems used in liquid pharmaceutical production Bachelor of Science in Operation and Information Management, May 2007 Northern Illinois University | DeKalb, IL Associate in Arts Degree, May 1998 Kishwaukee Community College | Malta, IL Continuous Improvement | Process Optimization | Change Management Lean Manufacturing | Supply Chain Management | Regulatory Compliance (cGMP) Budget Management | Forecasting | Supplier & Vendor Relations Project Management | Root Cause Analysis | Quality Assurance (QA) PROFESSIONAL TRAINING Project Management, 2018 | Green Belt Training, 2021 | Development Dimensions International, 2015 AWARDS PerfEx Award, 2017 (Performance Excellence Nominee), 2016 and 2017 (Friend of Quality Award), 2016 ACTIVITIES Bank of America Chicago Marathon | St. Jude Nashville Country Music Half Marathon TECHNICAL SKILLS Microsoft Office Applications (Word, Excel, Project, and OneNote) | Minitab 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