Senior Research Scientist for CMC Bioassay Development

Cari; København; Hybrid; DKK 651,000 - 957,000; Full time

Job summary

Novo Nordisk in Måløv seeks a Senior Research Scientist to lead potency assay development and optimization across clinical projects. You will translate project needs into robust analytical solutions, collaborating with technicians, scientists and project managers to deliver high-quality results.

The role emphasizes cGMP practices, regulatory involvement and continuous process improvement using LEAN and data-driven approaches.

Qualifications

• Hands-on experience designing and validating potency assays.
• Experience with cell-based bioassays and SPR methods in regulated settings.
• Knowledge of regulatory documentation and health authority interactions.
• Strong communication, collaboration and problem-solving abilities.

Responsibilities

• Design and prepare documentation for development and validation of potency assays (cell-based, enzymatic, chromogenic, SPR).
• Maintain and update analytical equipment documentation to ensure cGMP compliance.
• Collaborate with cross-organisational teams across CMC, Research, and manufacturing.
• Interact with health authorities and a wide range of internal/external stakeholders.

Skills

Bioassay development

SPR methods

cGMP regulation

Regulatory knowledge

Cross-functional collaboration

Communication skills

Initiative

LEAN principles

Automation and data

Education

Master's degree or PhD in pharmacy, chemistry, biophysics, engineering or related field

Job description

Senior Research Scientist For CMC Bioassay Development

Senior Research Scientist CMC Analysis & Characterisation CMC Bioanalysis Location: Måløv

Your impact begins here

Would you like to use your bioassay expertise to support innovative oral and injectable drug products throughout clinical development? Join CMC Bioanalysis in Måløv as our new Senior Research Scientist, where you will develop and optimise potency assays, collaborate across disciplines and help improve the way we work through automation, data and scientific curiosity.

What you’ll do

As a Senior Research Scientist, you will take scientific responsibility for the performance, development and optimisation of potency assays for selected clinical projects across the Novo portfolio. Working closely with laboratory technicians, fellow scientists and analytical Project Managers, you will translate project needs into robust analytical solutions and high-quality processes.

Your responsibilities will include:

• Design and prepare the required paperwork for the development and validation of potency assays from early to late-stage projects in phase 1-3 (e.g. cell-based bioassay, enzymatic assays, chromogenic assay and Surface Plasmon Resonance (SPR))
• Maintain and update relevant analytical equipment documentation to ensure sufficient cGMP
• Collaborate in cross-organisational project groups across CMC, Research Units and manufacturing.
• Interacting with Health Authorities related to clinical trial applications and Q&A, and a wide variety of internal and external stakeholders, e.g., Production, Regulatory Affairs, Quality Assurance and Analytical Development

Your work will extend beyond the department and connect with teams across analytical development, drug product development and stability testing, giving you broad exposure to the R&D clinical portfolio. Together with your colleagues, you will also improve processes and systems using LEAN principles and explore how automation and data can strengthen potency assay development and execution.

What you’ll bring

To succeed in this role, you hold a master’s degree or PhD in pharmacy, chemistry, biophysics, engineering or a related field. In addition, you bring:

• Hands-on experience developing cell-based bioassays and/or SPR methods, preferably in a cGMP-regulated pharmaceutical or biotechnology environment.
• Knowledge of regulatory documentation and experience supporting interactions with health authorities.
• Strong communication and collaboration skills, combined with initiative, and with an enthusiastic and can-do approach to solving problems.

A strong personal drive that is reflected in your desire to take initiative and see things moving forward in a dynamic environment where projects vary and thereby demand the need for flexibility and skills to organize and drive tasks. This role contains good possibilities for improving and developing your project-management skills.

You are a proactive team player who naturally builds strong relationships with colleagues and stakeholders across the organisation and demonstrates a flair for management. You bring a positive attitude, a good sense of humour and a curious mindset.

Who you’ll work with

You will join Team Bioactivity in the CMC Bioanalysis department, which is part of the CMC Analysis & Characterisation area. The team develops and supports potency bioassays used to analyse drug substance and drug product samples across Novo Nordisk’s clinical portfolio, including projects within obesity, diabetes, haemophilia, cardiovascular disease and growth hormone therapy.

Team Bioactivity consists of 10 scientists and 12 laboratory technicians with strong expertise in bioassays. Our tasks evolve as new development projects enter the portfolio, and we are committed to delivering high-quality results on time while learning from one another and improving how we work.

What you can expect here

You will work in an international environment where your scientific expertise is valued, and your contribution can influence decisions across functions and markets. You will be trusted to take ownership, encouraged to make your voice heard and supported in developing your skills. Together, we contribute to advancing innovative treatments for people living with serious chronic diseases.

What we offer

Salary: The annual base salary for this role ranges from DKK 651,000 to DKK 956, 900, depending on the level of the position. Placement within the range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge and relevant experience.

Incentives and benefits: The salary package may include short-term and/or long-term incentives and other employee benefits based on position level, location, functional area, and relevant market benchmarks. Learn more about our Reward Philosophy here.

Interviews will take place in late week 43 and early week 44.

For further information, please contact Senior Manager Susie Jelsbak Christensen at sujcnovonordisk

The hiring manager will be unavailable for questions during week 42.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.