Senior API Process Engineer: Scale-Up & Transfer Lead

Novo Nordisk; Kalundborg; On-site; DKK 651,000 - 957,000; Full time

Job summary

Novo Nordisk in Kalundborg seeks a Senior Process Engineer to strengthen product and process understanding in a state-of-the-art production environment. You will combine chemistry, biochemistry and pharmaceutical manufacturing with data-driven methods to support stable, compliant process performance.

You will transfer products from development into operations, gradually taking ownership of product-related activities and collaborating across production, development, quality and engineering to

Qualifications

• Bachelor’s, Master’s or PhD in biochemistry, chemistry, biotechnology, biomedicine, chemical engineering or another life-science discipline.
• At least five years of relevant experience, preferably within pharmaceutical manufacturing, API production, biotechnology or another chemistry-intensive production environment.
• Practical knowledge of chemical modification, protein chemistry, organic chemistry, downstream processing, purification or HPLC.
• Experience with cGMP, deviations, investigations, change control, qualification or validation in a regulated setting.
• Strong English communication and stakeholder management skills, with the ability to influence decisions, share knowledge and collaborate across functions.

Responsibilities

• Drive qualification and validation activities per cGMP and support new product transfers and processes.
• Develop detailed understanding of chemical modification, protein chemistry, purification and other core API steps.
• Analyze complex process data, identify correlations and root causes, and translate findings into improvements and monitoring.
• Take ownership of product-related activities, including deviations, investigations, change requests, product transfers and continuous improvement.
• Build organisational capability by sharing specialist knowledge and supporting colleagues in a growing team.

Skills

Strong English communication

Cross-functional collaboration

Data-driven decision making

Ownership mindset

Education

Bachelor’s/Master’s/PhD in biochemistry/chemistry/bi biotechnology or related life-science field

Tools

HPLC

Job description

Novo Nordisk in Kalundborg seeks a Senior Process Engineer to strengthen product and process understanding in a state-of-the-art production environment. You will combine chemistry, biochemistry and pharmaceutical manufacturing with data-driven methods to support stable, compliant process performance.

You will transfer products from development into operations, gradually taking ownership of product-related activities and collaborating across production, development, quality and engineering to