Sr. Manager / Associated Director for Drug Substance Development

Do you bring proven management skills from working in a development area and do you have a strong scientific background within Drug Substance Development? Join us on our exciting journey and become our new colleague in Pharmaceutical Development.

The position

• Drug Substance Development is a department within the Pharmaceutical Development function in R&D where we are approximately 50 people. The department currently consist of 10 skilled scientists and technicians and is responsible for drug substance development activities.
• As leader for Drug Substance Development, you will be part of the Pharmaceutical Development management team and report to VP of Pharmaceutical Development.
• We have projects in different phases, i.e. pre-clinical, clinical phase III preparations and also Life Cycle Management / optimization projects and the majority of our development activities are performed in-house. We are however also starting up a new project within Biologics (Mammalian) in cooperation with a CDMO.
• We primarily work with the unit operations extraction, particle separation, micro-filtration, chromatography, ultra- and diafiltration, and stabilization.

 Changes in priorities within development often require flexibility and adaptability. We handle this with a smile while helping and learning from each other in an informal atmosphere characterized by enthusiasm and commitment.

Responsibilities:

• Lead and develop highly skilled scientists and technicians and ensure a collaborative and high-performing environment.
• Collaborate with the management team and scientific experts in the department to shape innovative drug substance development strategies that drive our projects forward.
• Set scientific direction in our journey to develop robust and scalable drug substance processes and follow state of the art and new technologies.
• Oversee design/development studies to generate the necessary source documentation to support regulatory filings.
• Cultivate a dynamic environment with a high scientific standard, passion for learning and having fun while delivering results.
• Ensure compliance with adequate GMP requirements.

Your profile

We are looking for a leader who:

• Has minimum 7 years of experience in drug substance development within proteins and biologics.
• Has at least 3 years proven experience in a managerial or leadership role, with the ability to inspire, mentor, and develop a team of experts.Has an educational background with a master’s degree within engineering, natural science or equivalent.
• Is adaptable and solution-oriented, ready to lead the team to success with a high scientific standard.
• Has good analytical skills and like to contribute to data evaluation and problem solving.
• Communicate fluently, both orally and in writing in Danish and English
• Preferably has experience within drug development, regulatory filings, and requirements.

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 located 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 9, 2025. 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 VP, Martin Richter-Friis by telephone +45 22848859.

We look forward to hearing from you!