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<pre>Array ( [var] => cut_url ) </pre> Resume for Tarik S. for Executive Manager / Biotechnology & Pharmaceuticals in Chesterfield, Missouri. Search More Resumes for Executive Manager on Resumark.com #2ZJT2SWXK
 

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Resume for Tarik S. for Executive Manager / Biotechnology & Pharmaceuticals in Chesterfield, Missouri




Occupation: Executive Manager Industry: Biotechnology & Pharmaceuticals
Country: United States City: Chesterfield
State: Missouri ZIP: 63017



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     SUMMARY

Management  Skills
  • Productivity & Efficiency Improvement.
  • Team Management /Team Building.
  • Lunch New Product/Service development.
  • Cost reduction & Avoidance: LEAN/ OEE manufacturing.
  • Multisite Operations.
  • Budget Administration.
  • Training development.
  • Resource Allocation.
  • Policy Procedure.
  • Technology Acquisition & Transfer.
  • Infrastructure  reorganization
  • Technology Knowledge
  • All Pharmaceutical dosage forms delivery systems especially Parenteral and Solid dosage forms.
  • Pharmaceutical Kinetic troubleshooting & Galenical knowledge formulation.
  • Projects start up commercial & clinical
  • CFR /, FDA Aseptic guidance, cGMP, MHRA/EMEA/ EU GMP
  • Current regulatory requirements, Quality systems, OSHA and NRC.
  • Contribution in Consent Decree & FDA Warning letter resolution.
  • .

     

    Indepth expertise in Biopharmaceutical/ Pharmaceutical Operations and technical knowledge combined with outstanding leadership ability, technical and management problem solving skills. More than years of multinational experience: Europe, North Africa, Asia and the US. Core competency includes: 

                 CARRIER HIGHLIGHTS

  • Managed and supervised startup aseptic filling project of $ million value at Mallinckrodt : Building new sterile core, filler   Isolators and Lyophilizers.
  • Started up aseptic process filling facility of $ million value: New Prevnar® Vaccine project V at Wyeth Vaccines.
  • Decreased the filling and sterilization process time from to hours using LEAN principals at Mallinckrodt.
  • Reduced the equipment break down by % and budget by $. million using OEE principles, at Mallinckrodt.
  • Lunched new sterile products that generated $ Million in annual revenues.
  • Saved company$. million reducing the over time by % at Wyeth Vaccines.
  • Decreased system uptime from % to % and realized $ million in saving at Wyeth Vaccines.
  •  

    PROFESSIONAL EXPERIENCE 

    MALLINCKRODT/ TYCO HEALTHCARE Missouri –USA

    Production Manager/Engineer Project Manager Aseptic manufacturing: Nuclear Medicine          

    Managed & Supervised startup aseptic filling project of $ million value, Up to departments: Sterile core filling process /Protein Formulation, Lyophilization, Component area, Packaging department and Disinfection service: Supervisors, Coordinators, Engineer and technicians.

  • Supervised and audited daily aseptic filling and Formulation activities, Batch record, Investigations, Validation   protocols.                                                                                                                                                               
  • Devised alternative manufacturing /quality solutions when presented with "roadblocks" to ensure projects are delivered on time.
  • Expedited, coordinated and managed all issues arising in productions or projects.
  • Monitored project achievements through key milestones and/or metrics.
  • Collaborated with Quality Risk Management departments to identify, assessed and managed risks associated with projects and   business solutions.
  • Provided leadership, mentoring and ongoing support to alliance partners.
  • Established training approaches, methodologies and assessments as needed.
  • Provided scientific and technical support and assistance to engineering services executing their protocols.
  • Coached and trained supervisors and crew on aseptic process.
  • Reviewed ,approved and drafted SOP
  • Reviewed all supporting documentation required in regulatory applications for accuracy and completeness, and determined the applicability of supporting documentation for inclusion in regulatory submission.
  • Ensured PMO program and managed all aspect budget related to maintenance from concept through full execution.
  • Ensured successful design, implementation, tracking and revision of plan for assigned projects.
  • Initiated improvements to enhance the efficiency and the quality of the manufacturing process.
  •  
     
     
  • Resolved and troubleshot kinetic issues within filling and formulation department.
  • Instructed operators to be in compliance with cGMP/FDA /EU norms.
  • Improved and optimized the aseptic manufacturing structure on term of: Aseptic techniques, quality, productivity, training, & investigation.
  • Led team to support validation activities and met the deadline.
  • WYETH VACCINES Commercial & Clinical New York –USA                                                                  

    General Supervisor / Vaccine Project and Aseptic Operations

    Started up aseptic process filling facility of $ million value: New Vaccine Prevnar® project V:

  • Defined and managed all phases of startup operation including purchasing, installation outsourcing and maintaining a cGMP/GCP environment.
  • Coordinated between FDA commissionaires and management.
  • Supervised and planned daily activities related to new vial filling line project from commissioning to validation.
  • Executed, approved pilot test and scale up of aseptic filling process.                                                                                                                            
  • Led group of scientists that conducted IQ /OQ /PQ of process and equipment.
  • Provided input on equipment installation, start up operation and trouble shooting.
  • Drafted, reviewed and approved SOPs and batch records..
  • Engineered and customized vial filling line.
  • Generated weekly schedule/plan for all department activities.
  • Ensured appropriate communication on projectrelated matters with the delivery centre management. 
  • Coached and trained research scientist crew on aseptic process.
  • Supervisor Aseptic Biological Filling and Sterile Operations…continued

    A $ . billion vaccine product / Biooperators.

  • Managed the entire filling facility for Pneunoc valents vaccines. 
  • Added $ million weekly by adding an extra batch every week.
  • Reorganized plant supervision structure removing a level of supervision. Moved from two general supervisors and one manager to one supervisor.
  • Instructed biooperators daily to insure compliance with GMP and aseptic process guide lines according to European norms and FDA.
  • Audited and closed daily batch records.
  • Issued manufacturing investigation reports and supported the investigation group.
  • Supervised all environmental and metrological parameters.
  • Provided SOP and technical training for biooperators.
  • Supported and performed validation process.                             

  • Improved the manufacturing timing which increased productivity and efficiency, and reduced costs.
  • Prepared trending report of all manufacturing troubleshooting and informed management of any alarming variance.
  • Involved operators and technicians in planning and process redesign. These systems developed a highinvolvement culture that resulted in better business decisions and an energized and committed workforce.                                    
  • Initiated improvements to enhance the efficiency and the quality of the manufacturing process.                                                             
  • Established a new filling strategy that increased productivity and reduced number of biooperators within aseptic core.
  •  

    MENA TECHNOLOGY USA                                                                                                                          

    Manufacturing Supervisor

  • Organized and managed the formulation department of solid dosage forms: powder capsules and tablets.
  • Performed small scale up unit operation of Galenical development.                                                                                 
  • Instructed operators to be in compliance with GMP/FDA norms.
  •  
     
     

    HENKEL INC. North Africa /Germany                                                                                                                                                              Technical Engineer

  • Consulted with, and marketed to, the pharmaceutical, cosmetic and detergent industries..
  • Developed an overall direction, strategy and goals of pharmaceutical, cosmetic, & Detergent raw material sales Practice.
  • Formulated objectives, plans and targets for the new pharmaceutical, cosmetic, & Detergent raw material.
  • Supported pharmaceutical, detergent client in developing formula, and troubleshooting chemistry issues Lever, Ecolab, J&J, Colgate….
  •  

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