Manufacturing Lead (Biopharma, Denmark)

Job summary

The role involves acting as the business design authority within the Plan-to-Make global process for an ERP business transformation program in the biopharma sector. The Manufacturing Lead will ensure that manufacturing processes are accurately defined and standardized across sites, while adhering to compliance requirements.

Qualifications

• Proven experience in process design and standardization across multiple manufacturing sites.
• 8+ years of experience in biopharma manufacturing with strong knowledge of GxP.
• Strong communication and influencing skills, capable of connecting strategic vision to operational execution.
• Full proficiency in English; knowledge of Danish and/or German is a plus.

Responsibilities

• Co-lead the design of end-to-end manufacturing processes aligned with global standards.
• Govern standard vs. site-specific deviations in compliance with regulatory principles.
• Represent shop-floor needs in system design and validate core manufacturing flows.
• Embed GMP/GxP, QA, validation, and CSV requirements into process design.
• Define manufacturing master data and prepare sites for cutover and go-live.
• Facilitate change through training and operator-friendly instructions.

Skills

• Expertise in ERP platforms (D365 or SAP) and enterprise-wide transformation initiatives.
• Ability to collaborate effectively with ERP consultants and IT teams.

Education

• Relevant degree in a related field is preferred.

Tools

• Familiarity with ERP systems and digital transformation tools.