Scientist within upstream development - Biologics

Job title

Scientist within upstream development - Biologics

Do you bring knowledge and skills within upstream development from working within biologics in a development area and do you have experience taking a molecule from DNA to IND and beyond? Join us from the beginning of a new biologic development project and be part of our exciting journey in Global CMC-Development.

The position

In Global CMC Development we strive to develop world class products according to defined projects plans. In parallel we optimize and support our current legacy business to continuously secure robustness and efficient processes within Source material, Drug substance and Drug product and Device development.  We develop and optimize Analytical methods and support the business with critical reagents.  We manufacture clinical trial supply, and we support transfer of methods to our production areas.

We have projects in different phases, i.e. pre-clinical, clinical phase III and Life Cycle Management / optimization projects within the allergy field. We have started a new drug development project within Biologics (Mammalian) in cooperation with a CDMO. It is a new field for ALK, and we are therefore looking for a candidate with experience in upstream development within Biologics. 

As lead within upstream development, you will be part of the project CMC team but also be involved in discussions related to in- vs. outsourcing, CMC-planning and Regulatory Agencies interactions etc. Changes to plans often occurs within development so it requires a flexible and adaptable mindset. We handle changes with a smile while helping and learning from each other in an informal atmosphere characterized by enthusiasm and commitment.

The position reports to Sr. Manager, Drug Substance Development within Pharmaceutical development where we are approximately 50 people located in DK and US.

Responsibilities

• SME within Upstream development.
• Preferably, knowledge within cell-line development.
• Represent drug substance development, upstream, in the CMC-project team.
• Review development reports from our CDMO and anchor knowledge and the documentation at ALK.
• Contribute to the overall drug substance development plan from a scientific and strategic perspective.
• Build-up capabilities within upstream development activities.
• Make sure deliverables are aligned with overall project expectations.
  • Identify potential CMC issues and project risks and proactively implement mitigation strategies.

Your profile

We are looking for a candidate who:

• Has an educational background with a master’s degree within engineering, natural science or equivalent.
• Has SME knowledge and minimum 5 years’ experience within Upstream development, preferably early stage.
• Practical experience with upstream development and manufacturing is preferred.
• Preferably previous experience developing biologics from DNA to IND and beyond, either internally or using a CDMO.
  • Is adaptable and solution oriented.
  • Has strong communication skills, and fluent in English, both orally and in writing.

What we offer

ALK offers a dynamic and pleasant working environment with inspiring and challenging tasks. The results of your efforts will be noticeable throughout the organisation, and you will have the opportunity to actively influence and challenge the status quo. Our flat structures attract independent individuals who like to feel the development of the business and enjoy being close to the decision-making process. You will be part of a committed and informal team that focuses on competencies and knowledge development. We consider our pioneering spirit combined with credibility to be the recipe for success. ALK is a health-focused organisation, and our offices are in the scenic DTU Science Park in Hørsholm.

Apply

We invite you to apply by submitting your CV along with a brief letter of motivation. Please note that the application deadline is February 22, 2026. If you want to learn more about ALK we encourage you to visit us at www.alk.net. Do you have questions about the position, please contact Sr. Manager, Caroline Trebbien Gottlieb by telephone + +45 41 71 84 70.

We look forward to hearing from you!

Requisition no.: 0011555

Afdeling: Drug Substance Development

Cost Center: 10256