The Life Science Manager is responsible for the administration, coordination, and evaluation of the Life Science Unit, including new business, review for all new life science projects, and the growth and management of client relationships for the business unit.

An experienced project manager with a degree in mechanical engineering, providing expertise in the operations, quality and validation for manufacturing facilities. My passion is helping start-ups succeed and I possess the unique experience of having taken a start-up through PAI with the FDA and launching a product commercially.Strengths include:• Extensive hands on experience with biotech/pharmaceutical and cGMP facilities• Owner permitting and planning for life sciences• Commitment to operational start up and efficient facilities planningBackgroundIn my nearly 25-year career, I have provided project management across a variety of specialties. My career has grown from systems design for the production environment to managing and overseeing design and construction projects in production facilities. I have specialized in providing engineering oversight and ensuring operational efficiencies through device assembly and chemical handling. Senior Project ManagerExperienced in providing project delivery for general manufacturing and GMP facilities bringing an understanding of mechanical engineering and nuances in the production process for the life sciences sector. My experience in my own bio tech venture gives me the ability to truly understand the owner’s operational needs. My dedication and ability to communicate complex technical requirements help ensure the successful completion of projects for Hereva’s clients.

Responsible for overall coordination and scheduling of complex projects involving Engineering, Chemical Development, Analytical Development, GMP Manufacturing, Quality Control, Quality Assurance and Sourcing departments. Report on project status, communicates any issues, problems or additional information to clients, global project team and senior managers along with recommendations of solutions. Monitor and drive progress versus timelines, budgets and deliverables. Spend time with clients during on-site visits.RESPONSIBILITIES• Communicate in a clear and concise manner with clients, fellow project team members and occasionally with vendors.• Act as the client advocate on project teams, ensuring that a balanced viewpoint is taken.• Co-ordinate and drive projects internally to ensure that client timelines and deliverables are a primary focus.• Ensure that every project is suitably resourced and the project team is clear on overall goals.• Utilize Microsoft Office software to create realistic project plans (especially Gantt timelines).• Run regularly scheduled client meetings, prepare and distribute meeting minutes where appropriate.• Schedule and plan upcoming projects based on individual client needs.• Spend time with on-site visitors and participate in meetings with potential and current clients.

Facility SME, also responsible for managing the operational aspects related to combination product and device assembly and drug (chemical) handling at Finished Product Assembly and Packaging locations throughout Nypro. Provides subject matter expertise with regards to operations, facilities, process, resourcing, equipment and safety. Manages the execution of global pharmaceutical (drug) and diagnostic (reagent) handling programs including proposal execution and product costing and the acquisition, installation, and validation of facilities and manufacturing processes and equipment. Includes identifying and managing facility, quality systems, regulatory, and resource gaps to ensure program success. Will act as the product expert to ensure continuity of supply while in production.

Responsible for Project Management and Documentation Engineering work in the redesign of Master Batch Records and SOP's at a Biotech company located in the greater Boston Area.

Project Manager (Jan. 2010 thru completion in March 2011) Planned, managed and coordinated Pre-Commissioning, Commissioning and Qualification activities for a new vaccine plant located in Ocoyoacac, Mexico for Sanofi Pasteur – Aventis.  Coordinated program & activities of pre-commissioning / commissioning of Black Utilities systems and qualification of process systems with an eye towards program goals, usage of appropriate materials, functionality of equipment, scheduling issues, and budget considerations on $1MM project. Generate spending forecast for life of programs (Engineering costs and Expenses), Approve hours and expenses, report on Profit and Loss for program, generate risk assessment to budget, track budget actual costs, committed costs, contingency costs, estimate at completion costs and any variances to budget. Resourcing for program which entailed interviewing people to hire personnel with appropriate skill set to fill program needs. Deliverables for program: Generate Weekly Project Status Reports for team and client, generate Monthly Management Reports for Denmark (corporate headquarters), generate monthly project letter on challenges, successes and overall program performance, generate minutes of meetings for all appropriate meetings – internal and with client and generate Presentations for monthly Steering Committee Meetings between NNE and client. Provide Off-Site Infrastructure for team so they could perform their daily responsibilities required for the program – work visa’s, off-site housing, site trailer, PPE, Office supplies/support, etc.

Project Manager for the FAT required to supported NNE Pharmaplan Sweden office of 2 Isolator units being fabricated by Biospherix located in Lacona, NY.Upon a successful completion of the FAT the units were shipped to Sweden Linkoping University Hospital to be utilized in the regeneration of human optical components.

PM / Quality Engineer  Revising existing SOP's / Documentation / Protocols to address recent observations made during FDA inspection.  Current role is spearheading observations relating to the HVAC systems, in particular; cleanroom classification qualification strategies, HEPA testing and BSC's/Hoods testing criteria / certifications from vendors. Biogen Idec March 2011-November 2011

Genzyme Corporation, Framingham, MA Responsible for the planning, management, development and execution of capital programs for significant portions of Genzyme’s project portfolio, including new and existing sites. Projects included construction of new facilities, expansion of existing facilities, purchase and installation of equipment and improvements to existing equipment. Coordinate activities of architectural, engineering and construction management firms with an eye towards program goals, usage of appropriate materials of construction, correct selection and use of equipment, scheduling issues, and budget considerations on projects from $100K to $30 Million. Perform follow-up engineering activities such as systems modifications to ensure continual compliance with defined operating criteria to support on-going plant operations. Review and approval of engineering changes submitted by end users inclusive of follow-through to ensure completionEvaluation and management of proposed engineering changes, modifications in the field and ECR close-outs which included validation (IQ,OQ,PQ) and all appropriate documentation.