Project Manager

Aphena Pharma Solutions is looking for a Project Manager to join our team in Easton, MD! Aphena Pharma Solutions is a dynamic pharma solutions provider focused on contract packaging, repackaging and manufacturing for the pharmaceutical, OTC, dietary supplement, animal health and medical device marketplaces.

Position Overview
The Project Manager is responsible for the daily coordination of project management activities related primarily to regulated products including costing, new product manufacturability, launch, existing product changes, and creation/modification of Product Master Records. Project Management responsibilities extend from customer contract through transfer to commercialization post product launch. In addition, the position will perform analysis functions including cost/benefit analysis and cost estimation functions prior to contract, including cost sensitivity analysis to changes in input variables as relating to new product launches and initial review immediately following launch. The position will advise various other departments on issues related to new product opportunities, project launch activity status, and product changes. This position reports to the Manager, Project & Product Management who will define specific customers and or project responsibilities for this position.

Position Responsibilities

• New Product Analysis
  • Work with Operations, Engineering, Purchasing, Tech Services, Laboratory, and QA to determine feasibility of new products or product modifications.
  • Develop Phase I and Phase II costs for products deemed feasible.
  • Coordinate the production of samples for initial customer evaluation as related to new product launches.
• Project Management
  • Manage/Coordinate all project management activities related to new products and existing product changes in a multi-departmental (matrix organization) environment
  • Schedule and lead project team meetings to ensure timely execution of action items.
  • Work with other departments to ensure that sufficient resources are available for timely execution of projects.
  • Coordinate with customers as required.
  • Create and maintain project timelines and ensure all stakeholders are updated on progress.
  • Review and disseminate project requirements both internally and externally ensuring that the appropriate departments have access to project scope and requirements
• New/Modified Product Launches
  • Coordinate all development and documentation activities for regulated products (contract and Aphena owned), ensuring compliance to all regulatory requirements (US and overseas).
  • Coordinate the creation of all materials required by customers for regulatory submissions.
  • Responsible for timely, accurate development of Product Master Records.
  • Provide guidance in the creation of Master Batch Records as appropriate.
  • Ensure that all aspects of Product Realization are completed, as appropriate.
  • Lead risk management activities for assigned projects.
  • Provide guidance on feasibility activities.
  • Assist with development of strategy and coordinate performance of process validation activities.
  • Assist with development strategy and coordinate performance of cleaning validation activities.
  • Responsible for reviewing, negotiating, documenting and controlling all customer supplied specifications.
  • Assist with tech transfer from customers to Tech Services, Validation, and Laboratory.
  • Document Scope Change from initial product analysis activities and provide impact to the organization.
• Total Cost Productivity
  • Assist with standard cost review and update.
  • Work with Purchasing, Operations, and Engineering to drive specific, targeted cost reduction projects.
• Other:
  • Other duties and responsibilities as assigned.