Manager Manufacturing
Resume:
MAHBUBOOR R ANSARY (Rahman)
Hatfield, PA 19440
*****.******@*****.***
Summary
Motivated professional having many years in the manufacturing division within pharmaceutical industry. Fully trained on current Good Manufacturing Practices and Standard Operating Procedures relative to production. Possess supervisory experience necessary to complete any assigned task. Able to perform well independently or as part of a team to accomplish organizational goals and objectives. Boundless energy, capable of adopting a number of roles simultaneously. A natural entrepreneur, inquisitive and adaptable; embrace change readily. Multi-lingual---fluent in English, Hindi, Urdu and Bangle.
EDUCATION
Montgomery County Community College: - Electric Engineering.(1996 – 1999)
PROFESSIONAL EXPERIENCES
Polysciences, Inc (2015- On going)
Production / R&D Supervisor
• Highlight positive behaviors and best practices and provide course correction/disciplinary action in a timely manner. To oversee a group of technicians and packaging operations in a clean room or other production environment.
• Responsible for daily planning and resource allocation to meet monthly production demands, assure materials, components and associated paperwork are present, manufacturing and packaging spaces are available for use, and all training is complete and up to date for direct report assignments.
• Lead training initiatives. Provide coverage in the absence of the other Managers. Provide daily line assignments, establish re-work requirements and recommend recovery plans to keep technicians active.
• Daily, active presence on the production floor engaging operators, monitoring processes, spot checking batch records and paperwork.
• Execute housekeeping initiatives to drive cleanliness and organization Fully versed in all quality aspects of production.
• Provide documentation comments as necessary and close batch records upon completion. Provide investigational support and lead document development and redline activities.
• Maintain a strong floor presence to build relationships, drive performance and remove hurdles.
• Model a culture of safety and strive for 100% compliance with safety and training initiatives.
• Partner with department planners and/or site leadership to establish short term schedules to meet monthly demand.
• Allocate resources to production areas based on schedule needs.
• Monitor line performance against target standards and quality through put and make adjustments as necessary.
• Perform routine inspections of production areas, paperwork and product quality to assure correct and timely completion of activities to maximize line availability.
• Identify and implement a training plan to create a cross functional work force.
• Become established as a subject matter expert to complete gap assessments, investigations and process improvement activities not limited to paperwork, production areas, equipment and performance and provide recommendations for improvement.
MedImmune Vaccines (2008-2015)
Pharmaceutical Technical Specialist/ INOVA Fill Technician III (Flu-Mist / H1N1).
● Successfully performed all aspects of aseptic manufacturing of FluMist & H1N1 ensuring quality and patient safety. Performed a variety of tasks related to the processing of ingredients and/or pharmaceutical products. Operates general manufacturing equipment, such as autoclaves, and automated aseptic filling lines. Handles raw materials and intermediate or finished products. Assists in all direct manufacturing support functions such as Thaw, Blend, Fill, Stage, Prep, Environmental Monitoring (EM) and equipment preparation. Assists in indirect manufacturing support functions, such as cleaning and sanitization of the facility. Performs standard operating procedures to meet current good manufacturing practices (GMP). Accurately completes required documentation to comply with Federal regulations and assists with batch-record close-out. Maintains product related records as required. Author/revise SOPs and Batch records as needed.
● Composition and revision of standard operating procedures (SOPs) to ensure compliance with FDA and GCP/GLP/GMP regulations.
● Performed extensive personal development and training of new employees on (cGMPs), water sampling, fill equipment preparation, INOVA set-up, breakdown, and HMI (Human Machine Interface) usage.
● Demonstrating technical understanding and proficiency in operating all production automated and non-automated equipment including scale/balance, autoclave, pH meter, environmental monitoring equipment and tanks as stated in SOPs.
● Successfully operated in various environmental conditions including ultra-low temperature spaces utilizing proper protective equipment.
● Effectively followed procedures for handling sprayers between stage rooms, packaging rooms and storage areas and thawing frozen sprayers and transferring thawed sprayers for packaging.
● Followed all the procedures of Staging for Filling of product sprayers and performed inspection of sprayers for media and product fills for any defects. Accurately completed documentations to comply with FDA and GCP/GLP/GMP regulations.
● Performed multiple assignments in a timely, diligent and safe manner to comply with Regulatory Agencies both domestic and international (i.e. FDA, EMEA) with no supervision or minimum supervision.
Teva Pharmaceuticals USA (2001-2007)
Granulation Supply Supervisor (Solid-Dose).
● Project manager and Six Sigma Coach(Green belt).
● Organize and facilitate meeting.
● Superb coach, inspirational leadership that inspires employees to maintain peak performance and productivity levels while simultaneously maintaining high morale a cross the board.
● Provided superior leadership, direction and guidance for a team of 40+ diverse employees.
● Worked with R&D, AR&D, Pilot Plant, PE, Validations, QA, QC, warehouse and packaging as a part of the production team.
● Used Kan-ban and Kaizen methods to run lean manufacturing operations in packaging, dispensing and granulation.
● Worked with the warehouse to organize dispense on demand to make the department more efficient.
● Responsible for proper handling and documentation of controlled substances.
● Dispense and inspect weighed ingredients according to the batch card.
● Record and maintain batch records following all the procedures through the process mandated by FDA and USDA regulations approved formulary record, company G.M.P. regulation and company S.O.P.
● Set up, run and basic trouble shooting on a machine.
Central Sprinkler (1998-2001)
Material Handler and production Supply
Perform all material handling of product and components.
Martech Medical Products INC (1997-1999)
Production Supply/ Warehouse Management
Inventory Control, Forklift operation, UPS on line Shipping.
Technical Programs:
Oracle, SAP, AS 400 Systems, MS Office Suite: Word, Excel, PowerPoint, Windows 95/ 98/7/XP/Vista.
Top Skills:
● Batch records, documentation, FDA, packaging, aseptic, six sigma, lean manufacturing, Kan-ban and Kaizen.
● Used Kan-ban and Kaizen methods to run lean manufacturing operations in packaging, dispensing and granulation.
● Experience with quality system tool Trackwise
● Clinical Supply Distribution and Clinical Study Execution/GCP
● Intermediate software skills (e.g., Microsoft Excel, SharePoint, PowerPoint)
● Over 10 years’ experience in a highly matrixed environment
● Strong data analysis and problem solving experience (MS Excel, PP, Sharepoint and SAP)
Other Core Competencies:
Environmental monitoring, training, autoclave, automated equipment, cgmps, federal regulations, filling lines, gcp, glp, ground water, hmi (human machine interface), inspection, sampling, sanitization, sops, water sampling, excellent multitasker, manufacturing operations, project manager, QA.
Objectives:
● To successfully procure a full time position in a company that values integrity, innovation and accountability.
● To join a team that encourages personal growth, educational pursuits and career development.
● To successfully and effectively contribute to both team/company to help facilitate its future growth & success.
Contact this candidate