Strain Approval Scientist (Biotechnology, Bagsværd)

Job summary

This role involves working at the intersection of industrial genetic engineering, regulatory science, and product development to ensure compliance with global regulatory requirements for biotechnology solutions in food and feed markets.

Qualifications

• MSc or PhD in bioengineering, biotechnology, or biology.
• Excellent scientific writing and communication skills in English.
• Experience with genetic engineering and/or protein expression.
• Familiarity with product registration and regulatory approval processes.

Responsibilities

• Facilitate communication between R&D, Regulatory Affairs, Pilot Plants, and Quality Control.
• Collect, write, and deliver scientifically robust strain descriptions for product approvals.
• Support the generation of experimental data for strain characterization.
• Provide guidance to teams on regulatory readiness and approval.
• Enhance collaboration and information flow within the Strain Approval Support team.

Skills

• Team-oriented mindset with a focus on agile principles.
• Collaborative, curious, and self-driven approach.

Tools

• Experience with bioinformatics tools such as Benchling, CLC bio, and Python for analysis.
• Familiarity with document filing systems or quality management systems like Veeva Vault or Intelex.