Senior QC Scientist, BioAssay – Onsite Lab Build

Genmab A/S; Ballerup; On-site; DKK 624,000 - 936,000; Full time

Benefits offered by this job

Pension

Health insurance and wellness benefits

Paid time off

Employee support programs

Job summary

Genmab A/S is building a new QC Lab in Ballerup and seeks a Senior QC Scientist (BioAssay) to lead method transfers, validation, and SOP authoring. You will help establish key processes and collaborate with Utrecht and Copenhagen teams to set QC standards for clinical-stage programs.

The role demands a strong background in analytical science, ELISA methods, and regulatory expectations, with a focus on establishing a robust QC BioAssay group on site in Denmark.

Qualifications

• Master's degree or PhD in chemistry, biology, pharmacy, biotechnology, or related scientific area.
• 6+ years of experience in QC or analytical development, or PhD with 3+ years.
• Strong understanding of analytical science and its application across clinical development stages.
• Good understanding of validation concepts, risk-based approaches, and regulatory expectations.
• Experience with QC systems/tools (LIMS, SAS-JMP, SoftMaxPro).
• Experience with ELISAs and pharmacopeia methods for biologics.

Responsibilities

• Reviewing release and stability analyses.
• Supporting and training fellow scientists and lab technicians.
• Documenting validation activities of analytical methods for clinical programs and authoring SOPs.

Skills

QC experience

Analytical methods

Regulatory knowledge

Validation concepts

ELISA experience

Education

Master's degree or PhD in chemistry, biology, pharmacy, biotechnology, or related scientific area

Tools

LIMS

SAS/JMP

SoftMaxPro

Job description

Genmab A/S is building a new QC Lab in Ballerup and seeks a Senior QC Scientist (BioAssay) to lead method transfers, validation, and SOP authoring. You will help establish key processes and collaborate with Utrecht and Copenhagen teams to set QC standards for clinical-stage programs.

The role demands a strong background in analytical science, ELISA methods, and regulatory expectations, with a focus on establishing a robust QC BioAssay group on site in Denmark.