Manage two technology transfer projects of sterile injectables products from the original manufacturing site to a Contract Manufacturing Operation (CMO).  Responsible to provide operational strategic guidance and project execution management to the functional sub-teams (CMO, QA, Technical Services, Manufacturing, Packaging, RA) to keep deliverables on time. In charge of updating the project activity/risk tracker and the meeting notes.  Monitor, update and follow up the Project Schedule in MS Project and created new schedules for new technology transfer projects. Create monthly metrics and reports to monitor the performance of each project.

Provided Project Management consulting to Pharmaceutical Companies.Created project charter, SOW, Schedule, Budget and Risk Management plans for the launch of pharmaceutical products and Market Access Projects.Implemented the software Smartsheet as the management and collaboration tool for internal users and third party manufacturers.Created status dashboards and a project portal using Smartsheet to have all the information in one place.

Managed and oversee the co-ordination of clinical supplies integrated projects from award stage to completion, ensuring correct planning timelines are generated, monitored and tracked to ensure successful adherence and completion.

• Managed multiple projects impacting Product Development for new or enhanced products, engineering, cost containment and efficiency, and compliance initiatives. • Communicated verbally and in writing, cross-functionally, and with customers, vendors, suppliers, contractors, other sites and upper management on project related activities.• Facilitated and lead projects that pertain to Product Development for new or enhanced products.• Prepared and manage project plans to meet milestones.• Facilitated the removal of roadblocks and barriers that hinder or delay project progress.• Led meetings to facilitate project completion.• Delivered projects within the agreed upon timeline and budget.• Communicated project status and highlight critical path activities in a timely manner to management and Business Development.• Provided notification of milestone completions for billing to finance.• Oversee and managed capital appropriated for a project to ensure funding for the project goals are obtained, spent and closed in accordance with the project plan.• Communicated with supplier, vendor or contractor on project requirements and expectations.• Facilitated responses to customer questions and audit observations.• Ensure project requirements are consistent with current cGMP, EHS, and Financial industry standards.• Stayed current with the regulatory requirements and industry trends for project management. • Wrote plans, engineering drawings, business correspondence, and standard operating procedures. • Effectively presented information and respond to questions from groups of managers, customers, and regulatory agencies in writing and verbally.• Performed all of the foregoing applying knowledge of project management principles and concepts in a cGMP environment within the pharmaceutical industry.

• Provided leadership and project management skills in working manufacturing product transfers from customer’s donor sites to Bimeda’s internal sites, teaming up with multi-functional teams including Quality, Technical Services, Supply Chain and Regulatory to drive performance against targets.• Determined operations standard times, labor requirement and performed capacity analysis for the operations in order to efficiently plan the manufacturing of products to increase the productivity. Use MS Project to prepare the project schedules.• Created Scope of Works for pharmaceuticals contract manufacturing services (solid dose and aseptic filling) including the calculation of unit price using standard cost and the determination of Technology Transfer Costs (including Capital Costs) using Work Breakdown Structures to create project financial proposals for the customers. • Managed 7 to 9 project scope of works from the initiation, planning, execution, monitoring, closing and invoicing by using time charts in MS project, weekly meetings with multifunctional teams, communications and follow up for the efficient completion of all activities.• Succeeded in the selection of third parties manufacturers to outsource internal products. Led the RFP process, Technical Information, meetings, Supply and QA Agreements, terms negotiations and the site transfer management. Four (4) products were successfully transferred: two powder antibiotics, a large volume parenteral and a non-sterile liquid.

• Managed and control pharmaceuticals product transfer projects, including the continuous contact with the clients and the identification and troubleshooting of technical problems.• Led multifunctional teams including manufacturing, packaging, supply chain and QC/QA thru the initiation, planning, execution, monitoring and successful closing of pharmaceutical products transfers.• Developed project scope of works, time charts in MS project and project charters. Managed projects in weekly meetings, communications and follow up.

• Organized meetings with customers and project teams to manage new pharmaceutical products and process introductions, created quotations, reviewed product forecast, follow up outstanding payments, complaints and others. • Applied project management expertise toward profitably managing medium to large scale projects, including the implementation of new packaging closure systems, introduction of new packaging presentations, new process validation, tablet shape new design, process improvement, manufacturing of clinical lots etc. • Created project scope of works, time charts in MS project, project charters and change controls to start projects. • Demonstrated analytical abilities to determine new services and effectively develop new proposals and project plans and presenting proposals to customers and senior management. • Led a multi-disciplinary team applying six sigma tools (Fish bone, Pareto, trend analysis, regressions etc.) for solving critical issues that affect commercial accounts.

• Wrote Manufacturing/Packaging Process Validation Protocols, performed validation execution and final reports.• Prepared manufacturing and packaging work instructions, along with generating investigations and final reports of Out of Specifications (OOS).• Performed a process characterization to a Powder Filling process using DOE to determine the optimum parameters for the operation. The filler speed, vibration, bottle weight and conveyor speed were used as independent variable and the weight variation was used as the dependent variable.• Used Six Sigma tools to determine the statistical process capability of a powder filling process.• Provided training to manufacturing and packaging personnel.• Contributed expertise in the utilization of Six Sigma tools, including the facilitation of statistical tools as correlation, regression models, Design of Experiments (DOE), Control Charts, etc., to properly analyze and improved key manufacturing problems.

- Managed new filter product transfer and qualifications; handled investigations of Out-of-Specification events and analyzing raw materials / finished products for final disposition; recommended corrective actions as necessary.- Coordinated all line balance, standard time determination, and process improvement efforts for existing products, along with performing accurate layout design for Lean Manufacturing philosophy.- Directed wide-ranging capital projects (i.e. facilities expansion, new manufacturing equipment) to support new product initiatives; proficiently determined unit costs for new products.