The Project Manager (PM) is responsible for management of all assigned existing commercial or new products introductions. This position serves as the primary liaison between Aspire and the contracted client/suppliers/ external lab. The PM coordinates and tracks activities in all departments associated with the project; Procurement, Inventory Management, Manufacturing, Packaging, Analytical Testing and Development Laboratories. The PM is also responsible for daily production plans and ensuring monthly revenue goals are obtained. This position is responsible for internal and external agendas, meeting minutes, and ensuring that the client and Aspire project timelines are met in a timely manner.
Essential Duties and Responsibilities:
- Conducts and coordinates team meetings (internal, external, joint). Completes agendas and meeting minutes.
- Works with sales team and Supply chain to Creates, monitors, and updates product timelines as it relates to Quality team
- Interacts with clients and internal departments (Inventory Management, Manufacturing/Packaging, QC Stability Testing Lab, Analytical Development Chemistry Lab) in problem solving and status meetings.
- Tracks raw material/packaging components inventory and submits requests to Purchasing for order placement. Ensures incoming materials are sampled and communicates with the testing lab and quality when the materials are needed for manufacturing and packaging.
- Assists supply chain team in qualifying alternative suppliers for existing and new products.
- Completes weekly Project Status Sheet Reports and Quarterly Project updates to upper management.
- Generates material specifications, expiration and retest memos, rejection notices, sampling and packaging protocols, material transfer forms, stability submission forms and Notice of Events.
- Hosts clients when on site and accompanies client in the plant when observing manufacturing, packaging or analytical testing activities.
- Requests batch records to be issued and ensure master manufacturing and packaging records are effective.
- Knowledge of CGMP procedures and practices.
- Ability to work with others, understanding requirements of material receipt, manufacture, test and release as well as CGMP requirements for commercial production.
- Leadership abilities in dealing with details around production (ex: materials, documentation, scheduling, etc.) as well as administrative requirements for tracking project related tasks.
- Both oral and written communication skills are required for leading meetings (internal, external, and joint) which would include: scheduling, preparing agendas, collecting and issuing minutes, defining and tracking actions, etc.
- Knowledge of Computer Software Systems (Microsoft Office/Project, Electronic Document Management System, Investigation System (i.e. Trackwise) and Inventory System.
To perform the job successfully, an individual should demonstrate the following competencies:
strong 'quality first' mentality and ensure that product and process quality are held to the highest standard
Problem Solving - Reviews information and decimates to applicable departments. Gathers and analyzes information skillfully to effectively manage multiple projects and provides accurate information to appropriate decision makers.
Oral Communication - Works to effectively and cooperatively communicate various projects' needs and priorities internally with the company's staff and management team as well as externally with clients.
Written Communication - Writes technical and non-technical documents clearly and informatively. Including meeting agenda, minutes, action items.
Ethics/Professionalism - Works with integrity and ethically, maintains confidentiality. Interfaces with management and non-management employees in quality, manufacturing, research and development, laboratory services, project clients, third party vendors and consultants, and government agencies as required.
Organizational Support - Follows policies and procedures.
Adaptability - Ability to deal with frequent changes to schedules, delays, or unexpected events.
Attendance/Punctuality - Is present and prompt as needed to achieve success with objectives and projects.
Initiative - Takes introductory leading action to achieve objectives and project success.
Quality - Observes company quality policies and procedures.
Safety and Security - Observes safety and security procedures.
Education: Applicable Bachelors in Business, Science or Engineering degree or related field with at least 5 years solid dose and/or semi-solid pharmaceutical experience in one of the following areas: manufacturing, packaging, quality or analytical laboratory. Equivalent combination of education and experience or training is acceptable.