NPI Planner

Desired Skills: Raw Materials,NPI,Planning,SAP,GMP,Purchasing,Project Management

New Materials Introduction (NMI) Planner

The NMI Planner has overall responsibility for the planning and project management of the introduction of new GMP raw materials for the manufacture of multiple Bulk Drug Substances at our Dublin Manufacturing Facility (ADMF). The NMI planner must work closely with Technical Services, QA, QC, Warehouse, BDS Operations (end user), and with the Buyer to coordinate requirements, generate and oversee project plans to procure new materials requirements for multiple new products that will be introduced into the BDS facility. The key responsibility for this person is to ensure that all materials have their SAP master data created, material risk assessments and material specifications in place and are available onsite, tested and released by QC and QA as needed for use in the relevant tech transfer and manufacturing of drug substances, according to agreed new product introduction and commercial manufacturing schedules.

Principal Responsibilities

Identify Requirements and Suppliers

• Coordinate with Technical Services who will provide process descriptions and create bills of materials and with the strategic sourcing team and buyer to identify suitable suppliers, grades and pack sizes according to process requirements and following standard operating procedures for NMI.
• Work with Technical Services, Operations and Strategic Sourcing to ensure that the correct quantities are estimated to support technical studies, shakedown and engineering batches each new product introduction up to and including the process performance qualification batches (PPQ).
• Attend Material Review Board (MRB), Supplier Review board (SRB) and Qualification tracker meetings to ensure material and supplier is qualified for use.

Qualify new Vendors and New Materials

• Coordinate with QA, QC and Technical Services who are responsible for qualifying and adding new vendors and/or materials to the approved vendor list.
• Coordinate and plan the generation of technical risk assessments and material specifications by Technical Services and QC respectively.

Purchasing

• Coordinate with the Buyer to complete purchasing activities for all raw materials and components on the BOM, as well as any new consumables via the on-site vendor managed inventory service provider.
• Work with Manufacturing and other site departments to understand future material needs and develop a purchasing schedule.
• Support the Buyer as required to process purchase requisitions, enter purchase orders in SAP, and generate reports for upper management review.
• Support Raw Materials and SAP Process teams – identify problems, recommend process improvements, and work with the team on resolutions.

Planning/ Scheduling

• Produce BDS Master Schedules/ Plans as assigned and in conjunction with the buyer ensure that these are translated into SAP process orders in order to initiate MRP.

• Create Process Orders in SAP to initiate batch manufacture and coordinate with the finite scheduler to execute the BDS production schedule.
• Generate new material request forms to initiate Qualification of the material.
• Generate SAP master data for materials to allow the creation of Process Orders in SAP
• Update BOM and MES where required to support the manufacturing line.
• Chair weekly calls to support the NMI production for technology transfer.

Qualifications

• Proficient in use of SAP ERP system, preferably including familiarity with requirements and processes for material master data build and Bill of Materials creation, purchasing, MRP and production planning.
• System awareness: Veeva vault, SAP ECC and Smart sheet.
• Project management skillset.
• Planning experience in an MRP environment.
• Understanding of cGMP raw material purchasing requirements
• Excellent interpersonal and communication skills.
• Customer service oriented, self -directed, responsible, and able to work on problems involving various cross-functional groups.
• Ability to drive for results independently and adapt to rapidly changing priorities. Demonstrated ability to expedite and drive schedule adherence on an ongoing basis

Education

• 3rd level qualification in Business, Materials Management or Supply Chain Management/Logistics or other equivalent such as APICS qualification.
• Alternatively, a science based 3^rd level qualification, coupled with industry experience of aspects planning or management of raw materials and with the skills described below.

Interested candidates should submit an updated CV.

Please click the link below to apply or alternatively send an up-to-date CV to howie.leahy@peglobal.net

***Please note our client cannot assist with any Visa sponsorship and candidates must have the correct Visa to live and work in Ireland***