Director Project Management

Project ManagerResponsible for the overall management, direction, coordination, implementation, execution, control, and completion of specific projects ensuring consistency with company strategy, commitments, and goals.Responsibilities:Act as a liaison between internal/external stakeholders.Track client projects.Identify potential project pitfalls and coordinate with operations to apply effective strategies to overcome.Maintain and update project timeline to ensure client objectives are met.Chair project team meetings.Oversee and partner with the Project Managers to prepare meeting minutes.Manage billing milestones, capture subsequent additions to original work scope and relay information to the Business Manager/Account Manager.Ensure on-time delivery of project milestones.Attend external meetings as required.Manage client expectations and develop working relationships with client that foster business.Provide weekly updates to clients on project progress unless otherwise captured in meeting minutes from teleconference.Cost/Budget AnalysisGenerate KPI/reports.Optimize continuous improvement.Negotiate with vendors/external service provider.Manage ANDA/NDA drug development life cycle including R&D, deficiency, optimizing processes.Perform other duties and assist in special projects as assigned/required.Qualifications:BS in chemistry, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.Four (4) or more years of related experience, including some in the health/pharma industry.Project Management Professional certification (PMP) is desired.Demonstrate the ability to read and interpret documents such as safety rules, FDA guidelines and analytical procedures.Demonstrate the ability to write routine reports and correspondence. Ability to speak effectively before groups.Demonstrate conflict management ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.Demonstrated experience in successfully managing complex technical issues using structured analysis and methodology and articulating clear and concise direction to other operations staff.Demonstrate strong experience with project and people management.Demonstrate the ability to administer personnel performance evaluations.Demonstrate the ability to write and understand technical information and produce detailed reports.Demonstrates good leadership skills and the ability to establish and maintain good working relationships with other departments, including vendors, colleagues, and subordinates.Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.Must be able to comprehend and follow all applicable SOPs.Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.Demonstrate solid understanding of the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.Good understanding of cGMPs, industry, and regulatory standards and guidelines.Demonstrate solid understanding/use of Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.Demonstrate the ability to portray the appropriate level of integrity and professionalism.Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.Results-oriented and efficient.Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).Demonstrate the ability to work well in a cross-functional team environment.Must communicate fluently in English and have legible handwriting.Physical Demands:Ability to travel between and within facilities to visit staff, operations, and projects, as needed.Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).Ability to lift up to 40 pounds on occasion.Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).