PositionProject Manager
LocationVandalia, Ohio
SummaryThe Project Manager is primarily responsible for supporting and managing Research and Product Development projects. This includes effective project planning and monitoring, strategic alignment, multidisciplinary internal/external team coordination, process facilitation and communication both internally and externally. The position will require Project Management of multiple ANDA/NDA development projects. This will involve working with the R&D management and team members to develop appropriate project management systems for an organization undergoing considerable growth. The Project Manager must be able to effectively communicate with the customer, develop project plans (timelines) and ensure the plan is executed on time, complete agendas, meeting minutes. The position will require building positive working relationships that span all levels and functions of the organization.
Responsibilities- Manages the assigned Adare projects via optimal project planning and monitoring as well as coordinates with cross-functional project teams to deliver project results.
- Leads internal and external (customer) meetings, completes agendas, meeting minutes and project timelines using Microsoft Project and Adare's Project Management System.
- Manages customers expectation and critical development timelines.
- Tracks and ensures monthly and yearly forecasted revenue targets are being met for assigned projects. Work with the project team to identify associated risks and mitigation plans.
- Understands signed proposal activities being executed by the project team, identifies out of scope activities, and completes the appropriate Change Order to document new work being executed.
- Supports project teams by timely organizing activities linked to the projects, with other internal functions, such as Procurement delivery of materials, Engineering/ Operations support for small/ commercial and development scale equipment availability, and Regulatory/ Quality support, when needed.
- Seeks timely progress for actions and resolution to issues. Follows-up on critical action items and alerts all stakeholders of potential roadblocks or delays.
- Prepares bi-weekly project status reports and other project updates or reviews needed by the organization and presents to upper management.
- Supports different process initiatives and harmonization to improve pharmaceutical development productivity and performance.
- Must participate and successfully complete all training as required by the company.
- Perform other tasks assigned by the PM Management Team.
- Position requires being on-site 2-3 days a week at our Vandalia, Ohio (outside of Dayton) facility.
Experience, Education, and Skills Required- Bachelor's Degree in a related field, from a four-year accredited university or college
- A minimum of 4 years of experience in the pharmaceutical industry, CDMO experience is preferred but not required.
- A minimum of 2 years' experience in Project Management
- A certification in Project Management is preferred, but not mandatory.
- Excellent interpersonal written and oral communication skills
- Proficient in Microsoft Office (Word, Excel, Project and PowerPoint)
- Understands FDA Guidelines and Regulations and GXP's.
- Ability to coordinate, contribute to and work within cross-functional
