Program Manager

Job Overview:

Responsibilities:

• Manages multiple projects ranging from R&D to cGMP in all aspects of development including formulation & process development, analytical services, manufacturing, and packaging services from pre-IND/IND (early development) programs through Process Validation/PPQ 
• Manage projects and develop and maintain schedules, timelines, and milestones; lead project meetings, capture and distribute meeting notes; coordinate flow of documents within the company and to client organizations.
• Actively manage with the Finance team the financials tied to achieving project goals, as defined by the project plan and initiation of change orders if required when the scope of work has changed.
• Work with Business Development to ensure project scope is maintained to support effective execution.
• Promotes collaborative relationships with internal and external team members.
• Proactively identifies and facilitates the resolution of potential risks to the critical path of projects.
• Leads day-to-day operations of project team members including scheduling, communication, and billing.
• Work with peers and other leaders across the organization to effectively achieve project goals.
• Facilitates internal and client project meetings, including capturing meeting notes, project timelines.
• Manage changes to project scope without unduly affecting project objectives. Timeline: initiate change order requests to keep track of additional work
• Develops project plans and manages effective execution of project tasks.
• Support Project Management departmental activities and objectives to deliver maximum performance.
• Perform other duties as assigned.

Qualifications: 

• Bachelor’s degree, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
• BS degree in Physical Science or Business Administration is desired.
• A minimum of 3 years of Project Management experience in a healthcare related field or specific Pharmaceutical CMC, Regulatory affairs, R&D experience within the Pharma/CDMO industry preferred.
• Ability to be detailed oriented, anticipate potential issues, and work with both internal departments and when appropriate external clients to develop contingency plans.
• Excellent communication, presentation, and organization skills.
• Demonstrated success in delivering projects on time with client satisfaction.
• Strong work ethic and customer focus orientation 
• On-site position/support required to interface and network with key internal stakeholders.
• Experience managing internal resources and dealing with external contractors/vendors/clients.
• Demonstrate the ability to establish 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 ability to acquire the appropriate knowledge from resources in electronic Quality Management Systems such as MasterControl and Trackwise.
• Demonstrate ability to acquire the appropriate knowledge from resources on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
• Demonstrate ability to acquire the appropriate knowledge from resources on cGMPs, industry, and regulatory standards and guidelines.
• 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).