Project Manager /Alliance Manager with 15+ years of experience and a solid understanding of the Pharmaceutical, Device, & OTC Healthcare Industry. Skilled in project planning & tracking, new product development, quality programs, preclinical and clinical development, compliance testing, contract negotiations, and team building to meet business goals. Proven ability to apply technical and hands on knowledge to increase organizational efficiency and enhance product improvements. Team-oriented leader with hands-on management style. Specialized Skills: Strong communication and interpersonal skills collecting and disseminating necessary information. High sense of urgency in completing projects according to developed project plan and within stated budget. Possess a solid understanding of Federal guidelines ensuring compliance during development, testing, and release of quality products to the marketplace. Solid background in computer programs (Project, Word, Excel, PowerPoint). Highly adaptable and motivated to take on new challenges/opportunities.

Associate Director; Project Management @ Proactively manage cross functional teams to achieve project objectives and goals. Maintain communication and track projects amongst team members and R&D Leadership for ongoing tasks, addressing issues, and developing remediation plans to maintain approved timelines. Maintain and continually review project timelines identifying risks to the program, question how tasks are being completed, and relay concerns to the team. Play a key role in completing listed projects on schedule and on budget across various departments of IKARIA. From June 2009 to Present (6 years 7 months) Project Manager @ Proactively manage cross-functional teams consisting of technical and non-technical personnel to assure compliance to established portfolio timelines. Lead portfolio management analyses for strategic investment decisions. Prepare and distribute key project tracking documentation to organization Lead collection of required documentation for NDA/IND/ANDA submission in eCTD format to Regulatory Agencies. Prepare for PAI inspection. Manage and sustain external alliances with external business partners Identify and acquire necessary resources (materials, equipment, and manpower). Direct scale-up and validation efforts. Coordinate technical transfer to outside 3rd party manufacturers. Present project status, current issues, and next steps to various levels of management moving project to next phase. Identify business opportunities/programs for new technologies and cost savings. Clinical Project Management Manage identification of appropriate CROs for Phase I and II clinical studies producing the strong and successful study Lead manufacturing of clinical supplies supporting business objectives and NDA filings; negotiate for equipment, resources, and manpower to meet project timelines. Assisted in development of Clinical Pharmacy Unit developing systems for clinical studies. Negotiate with outside parties for clinical packaging, labeling, storage, and shipments of drug products Track clinical timelines maintaining schedule for Track clinical budgets for Phase I and Phase II clinical studies Review protocols and investigator brochures Present clinical study program information to investigators at study investigator meetings; address questions. From December 2005 to March 2009 (3 years 4 months) Project Manager @ Proactively manage cross-functional teams consisting of technical and non-technical personnel to assure compliance to established portfolio timelines. Lead portfolio management analyses for strategic investment decisions. Prepare and distribute key project tracking documentation to organization Lead collection of required documentation for NDA/IND/ANDA submission in eCTD format to Regulatory Agencies. Prepare for PAI inspection. Manage and sustain external alliances with external business partners Identify and acquire necessary resources (materials, equipment, and manpower). Direct scale-up and validation efforts. Coordinate technical transfer to outside 3rd party manufacturers. Present project status, current issues, and next steps to various levels of management moving project to next phase. Identify business opportunities/programs for new technologies and cost savings. Clinical Project Management Manage identification of appropriate CROs for Phase I and II clinical studies producing the strong and successful study Lead manufacturing of clinical supplies supporting business objectives and NDA filings; negotiate for equipment, resources, and manpower to meet project timelines. Assisted in development of Clinical Pharmacy Unit developing systems for clinical studies. Negotiate with outside parties for clinical packaging, labeling, storage, and shipments of drug products Track clinical timelines maintaining schedule for Track clinical budgets for Phase I and Phase II clinical studies Review protocols and investigator brochures Present clinical study program information to investigators at study investigator meetings; address questions. From February 2005 to December 2005 (11 months) Sr. Supervisor, Quality Control @ Managed 24 colleagues with daily prioritization, organization, scheduling, and testing within Quality Control department. Increased communication between cross functional groups relaying customer's needs and expectations for testing or release of solid oral dosage products. Developed and oversaw compliance programs within organization increasing efficiency and cost, teamwork, and regulatory compliance. Directed Raw Materials group scheduling, testing, and release of all incoming materials meeting the customer's needs. Develop scheduling and tracking systems of submitted samples using Microsoft Excel and Access programs. Guide programs increasing efficiency of laboratory (e.g. Six Sigma, Skip-Lot programs). Interact with the FDA during site inspections and assist the organization developing responses to 483 observations. Prepare and present monthly review reports to leadership team as to project status, issues faced, actions taken, resolutions, and next steps. Develop programs with outside contracting facilities ensuring quality work performed while meeting project goals. Create, write, and/or revise procedures (SOP), methods, or specifications increasing compliance of laboratory. Review Method Transfer, Process Validation, Cleaning Validation, and Deviation reports. From May 2004 to February 2005 (10 months) Project Planner @ Coordinate, plan, and schedule daily work needs and programs within Quality Control. Communicate project needs and status with respective groups daily. Review equipment and manpower determining needs for meeting organizational needs. Organize daily schedule and project needs based on organization's priorities of Quality Control Department. Lead cross-functional teams communicating daily, weekly, and/or monthly needs to respective internal groups. Conduct daily follow-up of projects - reviewing status, identifying issues, and seeking solutions. Develop tracking systems for monitoring product metrics (cycle times, stage, deviations); report to management. Devise organizational and project strategies, meeting future expectations of organization. Direct process validations during development of new products or optimizing existing products. From April 2003 to April 2004 (1 year 1 month) Associate Scientist/Project Manager @ Manage daily prioritization, organization, and scheduling of product testing during development, commercialization, launch, and post market. Created and tracked department and divisional budgets monitoring project status. Managed internal and external quality testing of all Adams' R&D projects with expected 2003 sales of $200 MM. Devised project Excel tracking system that increased communication and customer service within organization Identify external testing facilities and negotiated pricing list saving $500K annually on project budgets. From January 2000 to October 2002 (2 years 10 months) Scientist @ From 1993 to 2002 (9 years) Associate Scientist @ Managed department of 6 colleagues in providing microbiology laboratory support for OTC product development, global regulatory requirements, and stability reports. Designed and implemented quality (HACCP) program. Performed follow-up audits as necessary. Researched new technologies improving testing techniques and workflow. From January 1998 to January 2000 (2 years 1 month) Sr. Assistant Scientist @ Performed microbiological quality tests on OTC consumer healthcare; lead investigations when necessary. Reorganized workforce to meet specific needs of organization improving team dynamics and communication. From January 1996 to January 1998 (2 years 1 month) Assistant Scientist @ Performed microbiological quality tests, created scientific research reports, and presented information to development teams. From January 1993 to January 1996 (3 years 1 month)

MBA, Marketing & Finance @ Rutgers, The State University of New Jersey-Newark From 1997 to 2001 University of Dayton From 1989 to 1993 Masters, Business Administration; Marketing @ Rutgers Graduate School of ManagementBachelor of Science, Major Biology @ University of Dayton