Process Expert – Drug Product (DP)

About the role

We are looking for a Process Expert – Drug Product (DP) to lead and coordinate technical activities for drug product manufacturing at our site. The role supports legacy product continuity, new product introductions, technology transfers and process validations while ensuring compliance with GMP, specifications and regulatory requirements.

Key responsibilities

• Act as the primary DP process contact for new product introductions (NPIs), technology transfers, and validation projects.
• Coordinate technical transfer and commercial manufacturing campaign activities across multi‑product projects.
• Drive process improvement initiatives for large‑scale manufacturing, including implementation of new technologies and PAT.
• Collaborate with Site Project Manager and DP Associate Manager on product strategy and change‑control proposals.
• Prepare and deliver required documentation such as strategy plans, protocols, reports and change‑control records.
• Manage documentation and data using QMS tools (TrackWise, ManGo) and ERP systems (SAP).
• Support production troubleshooting, investigations and ensure compliance with GMP standards.

Required profile

• Strong background in drug product manufacturing and process engineering.
• Experience with technology transfer, validation and large‑scale process improvement.
• Good understanding of GMP, regulatory specifications and change‑control procedures.
• Ability to work cross‑functionally with project managers, quality, and manufacturing teams.

Required skills

• TrackWise (QMS software)
• ManGo (QMS software)
• SAP (ERP system)
• Process Analytical Technology (PAT)