PROFESSIONAL SUMMARY:

• I have over 7 years of Project Management experience and have successfully managed complex projects in matrix environments. I have demonstrated proficiency and successfully applied SDLC Lifecycles and PMI Recommended Methodologies to manage projects in Pharma/Biotech and Software Customization industries. I am a trained facilitator with an exceptional communication skill and ability to influence stakeholders’ decisions.
• 3 years of software customization project management experience and have successfully identified all stakeholders, collected and managed their requirements, verified scope developed realistic timeline and budget against established baselines.
• I have successfully managed scope, Cost and Schedule baselines and adhered to Project Management Institute Recommended Methodologies for the SDLC:
• Identified stakeholders and managed their requirements. Reviewed project scope, SOW and preliminary/core resource. Reviewed hardware/software, connectivity/support environments; Participated in Requirements Analysis for system requirements; evaluated and selected external vendors for project outsourced activities
• Sequenced project activities, determined Resource/Cost Estimates, and managed procurement activities for project budget.
• Documented milestones/deliverables. Determined schedule and managed project timeline using MS Project software
• Managed Planned Cost against Actual and analyzed Cost Variance

PROFESSIONAL EXPERIENCE:

Confidential

Project Manager

Responsibilities:

• In consultation with appropriate stakeholders, prepare and manage project plan in accordance with Project Management Institute’s project management standards as well as the Project Management Office standards.
• Work with the various Confidential school health personnel. Document, verify and get approved all the project requirements, screens, data fields, variables, descriptions, calculations, reports, work flow and other development needs of the project.
• Use a web - based project management environment to document all project plans, milestones as well as all project related documentation.
• Manage procurement and deployment of PCs and peripherals to all locations.
• Coordinate and manage the training and activation of all users.
• Coordinate work and interface with Confidential and Confidential personnel as needed.
• Keep track of and resolve issues and problems.
• Identify and manage project risks.
• Provide reports and maintain appropriate communications with all stakeholders.
• Work with stakeholders to develop access control and data integrity and quality needs and work with system administrators to implement and monitor the solutions.
• Maintain workload statistics, prepare narrative and statistical reports accounting for activities and maintain database and system documentation.
• Successfully implement School Confidential project within agreed upon schedule and budget.
• Maintain regular communications with all stakeholders and ensure that all stakeholders are able to see real-time project status at any time using a web-browser.

Confidential, Rockville, MD

Senior Project Manager

Responsibilities:

• Drove cross-functional, operational integration for the Product Development Team, including coordinating cross-functional activities and communications involving team members and Global Partners with minimal supervision.
• Coordinated the creation and maintenance of the integrated Product Development Plan and timeline.
• Ensured linkage between strategy and operational activities.
• Identified issues and facilitated problem-solving, contingency planning, and decision-making.
• Informed key stakeholders of status, issues, problems, and proposed solutions as appropriate.
• Assumed full responsibility for managing specific aspects of the project as designated by team leadership.
• Partnered with various international team leaders to foster effective team dynamics.
• Provided performance feedback to team and cross-functional line management on Product Development Team members.
• Collaborated with cross-functional team members to support the PDT's strategy and execution of deliverables.
• Worked with the PDT to develop, maintain, and align an accurate, integrated project timeline, resource plan, and budget.
• Understood critical path activities, anticipated risks, and created contingency plans in collaboration with project teams.
• Generated timeline, resource, and budget information that facilitate scenario planning, contingency planning, risk assessment and management, problem-solving, and decision-making.
• Monitored and managed team performance metrics relative to agreed upon project plan.
• Coordinated interactions with corporate governance bodies to ensure programs have adequate budget and resources to support approved scope.
• Identified deviations from Confidential -approved project plans and timelines and informed the PDT as to their nature and extent.
• Negotiated with team members to establish new timelines aligned with corporate goals
• Applied Project Management Methodologies to execute and monitor work packages

Confidential, Easton, MD

Project/Product Manager

Responsibilities:

• Worked with Manufacturing, Engineering, Purchasing, QA and the Laboratory to determine feasibility of new product or product modification.
• Developed Phase 1 and Phase II costs for products deemed feasible
• Coordinated the production of samples
• Coordinated the performance of PSPs if required to determine feasibility
• Conducted Confidential return on investment analyses as needed
• Managed/Coordinated all project management activities related to new products and existing product re-design in a matrix environment
• Scheduled and lead project team meetings to ensure timely execution of action items
• Worked with other departments to ensure that sufficient resources are available for timely execution of projects
• Coordinated stability runs for FDA and other regulated products in concert with Regulatory & Quality department
• Reviewed, negotiated, documented and controlled all customer supplied specifications
• Assured compliance to regulatory document control requirements
• Implemented CAPA to enforce quality and standard specifications
• Reviewed and updated cost baseline
• Worked with Purchasing, Manufacturing, and Engineering to drive specific targeted cost reduction projects
• Assisted in Developing timely and accurate Product and Batch Master Records
• Ensured that all aspect of Design Control are completed as appropriate
• Ensured that IQ/OQ/PQ and PVs are performed as required on new or modified processes.

Confidential, Corvallis, OR

Project Manager

Responsibilities:

• Managed candidate selection and preclinical assessments of drug development
• Developed and managed timeline
• Identified inadequacies in development plan
• Developed project contingency plan
• Revised Performance Schedule as needed and appropriate
• Managed, organized and documented team meetings at appropriate development stage
• Generated monthly progress report, accomplishments and disappointments
• Communicated project issues with the management and generated action plans
• Provided general support for product development
• Defined objectives, assumptions and constraints of the project
• Determined the project tasks and organized the tasks into milestone
• Estimated resources need, task durations and created relationships between tasks
• Managed vendors: participated in vendors technical performance evaluation, RFP, RFQ and selection processes
• Set up methods for communicating with the project team and kept the project up to date

Confidential, Frederick, MD

Project Manager

Responsibilities:

• Coordinated training and enforced adherence to updated process improvement
• Mentored, coached and prepared team members to achieve unit goals
• Managed all resources and tasks in an efficient manner, including collaboration with other members of the Confidential Management team to achieve common goals and objectives
• Participated in all repository operations, including communication, coordination and prioritization of activities as appropriate.
• Reviewed and approved all documentation associated with projects
• Coordinated and conducted investigation to resolve data discrepancies and communicate with the clients
• Monitored project expenses and ensure that project is monetarily on track
• Enforced GMP/GLP/GDP/ISO regulations and standards as applies to the group.
• Supervised and managed staff in keeping with objectives and corporate culture.
• Communicated with clients and collaborators with regard to data management, specimens tracking both internally and externally
• Assisted clients, collaborators and senior management in the implementation of new studies and protocols
• Prepared reports and correspondence to clients and collaborators and department directors
• Made recommendations on new business opportunities as appropriate
• Assisted in bidding on new projects, writing proposals, and preparing budgets
• Assisted in the development and implementation of new repository projects
• Kept current on Confidential shipping regulations and maintain certification and standards
• Implemented CAPA to enforce quality and standard specifications

Confidential, Vienna, VA

Project Leader

Responsibilities:

• Served as a team member on toxicology studies in primates and small animals
• Kept current on Confidential shipping regulations and maintain certification and standards
• Ensured quality control procedures are carried out according to SOPs
• Provided clinical study management and assure overall successful conduct of assigned clinical studies consistent with applicable guidelines
• Interfaced with representatives from key functional groups; Analytical Chemistry, Clinical Pathology, Report Coordination, and Study Direction
• Collaborated with other departments to coordinate clients site visits and activities with study needs
• Prepared diets, gavages, intravenous and capsules with test materials and vehicles according to the established protocols and SOPs.
• Prepared study-related documentation from initiation to completion of a study.
• Responsible for QA audits and clients study-related inquiries
• Implemented CAPA to enforce quality and standard specifications
• Maintained and achieved study raw data/materials as outlined under GLP/cGMP requirements
• Responsible for DEA Controlled-Materials that are assigned to a specific study as established in the company SOP
• Mentored team members and coordinated Process Improvement Plan
• Six-Sigma member

Confidential, Manassas, Virginia

Business Development Coordinator

Responsibilities:

• Acted as a liaison between Confidential scientific collections and the scientific community
• Propagated and authenticated microbial strains for Research and Development
• Managed various contracts for pharma, biotech, academia and research institutions
• Provided customers with technical data on biological materials and information on product patenting and regulatory issues
• Worked collaboratively with software developers to communicate website development
• Planned, prepared, edited, wrote and disseminated newsletters, articles, and other collateral pieces
• Assisted customers in the proper selection of biological materials
• Supported pre- and post-sales technical inquiries
• Interacted with scientific staff and product managers to increase technical service competency and customer satisfaction