Project Manager – Formulations Central New York State Our Client is an industry leader in contract manufacturing and packaging, for the pharmaceutical industry. Services include: Solid Dose Manufacturing with specialization in non-potent and intermediate potency tablet and capsule solid dose forms, as well as semi-solid and liquid dose forms. Packaging Services in a variety of forms including semi-dose, semi-solid and liquid-fill. Small Scale Equipment meets the needs for lower volume, quicker to market requirements. Capability to manufacture and package hydrophilic polyurethane sponges using proprietary blending and forming equipment. Assist customers throughout the life cycle of a product, as well as help plan and launch new initiatives, from simple line extensions to explorations into new product categories. Responsibilities: Performs as a Project Manager (PM) for new initiative start ups, major business initiatives, and major commercial projects/improvements. The PM leads and coordinates the transfer process from the time of contract approval to turnover to production & customer service (approximately validation). The PM leads the cross-functional team to bring in new products, equipment, and processes into the facility. Members on the cross-functional team will typically include: QA Methods, QA Systems, QA Standards, Process Engineer, Validation, Mfg. representative, Pkg. representative, Logistics/Sourcing and Safety. Typically, the PM will be managing 2-4 projects (dependant on complexity) at a time by managing multiple priorities. Develop, maintain and meet transfer/start up schedule. Microsoft Project is used as the primary software tool to aid in this activity. PM is responsible to ensure the schedule is met. PM is to help identify and remove barriers to successful execution. Perform as primary interface for customer. PM is responsible to insure an excellent relationship with the customer is maintained and that the customer needs are being met. PM is responsible as primary conduit for communications and to coordinate/to be cognizant of `technical experts' discussions across the customers. Ensure Project Budget is met. Approve project spending. Secure Capital funding as required. Manage cost and income for the project. Ensure that contract deliverables are met on time. Manage project scope. Adjust project scope as necessary to meet customer needs, redefining the scope and costs as necessary. Develop conversational expertise (working knowledge, but not expert) in all phases of technical transfer. This includes processing steps and technologies, method types, specs & standards, SAP requirements, plant systems, etc. Occasionally help out in other areas of the project which may include equipment installation, IOQ, validations, etc. Ensure project meets site requirements (Techs-NM, Validation Change Control, Safety, Environmental, Compliance, Training, Spare parts, Preventative Maintenance, Turnover Criteria to Production & Customer Service etc.) Ensures short and long term project plans and goals are in place and are aligned with Site business objectives and Department goals. Interfaces with the Process Engineering, Facility & Equipment Engineering, QC, QA, Manufacturing Operations, Packaging Operations, Logistics, and Customer Service staff to align resources to deliver project expectations. Builds mastery in the assigned areas in self and others. Ensures that safety and efficacy of products manufactured are never compromised. Ensures assigned CAPAs eliminate root cause and get completed on time. Supports Agency and Customer quality audits. The primary role of the Project Manager is to ensure excellent relationship with the customer and to ensure the project meets deliverables on required timing by coordinating the work of many resources. The PM is not expected to master all phases of technical transfer. Qualifications Bachelor of Science/Bachelor of Engineering (BS/BE) or equivalent combination of experience and education. Experience: 3-5 years of project management experience in a Manufacturing and/or Packaging Facility Decision Making Review and approve documents as required. Provides input for product and material release/reject decisions made by the Quality Assurance Organization as needed. Determines required technical training and champions the resources to deliver against specific training plans.