R&D Senior Process Development Specialist

Náplň práce, právomoci a zodpovednosti:
The role is a part of the Oral Health New Product Development Team (OH, NPD) based at the Global Oral Health Scale-Up Facility (GOHSU) in Levice and supports the development of (OH) products. This Team is critical in supporting formulation, process development, scale-up activities, and the manufacture of products for pivotal stability, clinical, and other human-use studies. The team will enable our facilities to operate seamlessly, maintaining compliance with cGMP requirements and fostering a culture of quality and safety.

The Senior Process Operator's primary focus is delivering the customers’ project requirements while ensuring compliant, flexible, and fast-paced operations that support process development, scale-up activities, pivotal stability, clinical, and other human-use studies across all categories for CHRD. The role will support the site lead with facilities-based initiatives, utilities, and infrastructure in line with EHS and cGMP requirements. This role also acts as an expert within its field of expertise (supervision and manufacture of R&D batches to cGMP). The position will provide coaching and mentoring to others and work on cross-functional initiatives to ensure that the capability of the operations team remains fit for purpose and compliant with regulatory requirements.

Key Responsibilities

• Developing and championing scale-up understanding and process development.
• Developing an understanding of equipment and products in terms of processing.
• Overseeing the operation of manufacturing equipment to ensure safe and compliant use.
• Creating, reviewing, and approving documents, including batch documentation, experimental plans/reports, change controls, deviations, technical rationales, and investigation reports.
• Exercising a wide degree of independent technical sophistication in accomplishing assigned tasks.
• Being a Subject Matter Expert (SME) for technical/material risk assessments (TRA/MRA) from an equipment and process perspective.

Požiadavky na zamestnanca:
Degree level or/and 5 year relevant expierence

Prefered Experience of : ERP systems, processing of semi-solid products, cGMP, coaching/mentoring