Senior CMC Project Manager - Biologics

Do you bring Project Management skills from working in a development area? Do you have experience within Biologics and working with CDMOs? Join us from the beginning of a new drug development project and be part of our exciting journey in Global CMC-Development.

The position
You will as CMC Project Manager join Global CMC-Development with approximately 50 people based in DK and US. We run projects in different phases, i.e. pre-clinical, clinical phase III preparations, and Life Cycle Management/optimization projects.

We are starting up a new drug development project within Biologics (Mammalian) in cooperation with a CDMO, and we are looking for an experienced CMC project manager for this project. For ALK, this is a new field why a candidate with experience within Biologics is important.

In this role you will work closely with cross-functional teams preparing project plans and executing the CMC activities. Changes to plans often occurs within development, which 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.

As CMC Project Manager you will be representing the Global CMC area in the Project Core Team and you will report to the VP, Pharmaceutical Development.  

Responsibilities covers:

• Chair the CMC project team and ensure clear direction and communication and cross functional cooperation and alignment.
• Develop and maintain CMC project plan, timeline and project budgets and oversee the progress of our internal CMC activities.
• Represent G-CMC in the Project Core Team and make sure CMC deliverables are aligned with overall project expectations and manage stakeholders.
• Oversee the relationship and communication with our CDMO, ensuring alignment with project timelines, deliverables, CDMO budget and regulatory requirements.
• Identify potential CMC project risks and issues and proactively implement mitigation strategies.
• Collaborate with the management team and scientific experts to support the development of our strategy for in- and outsourcing activities within Biologics.

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 minimum 5 years of experience within drug development, Biologics.
• Has proven project manager skills from a development environment and ability to lead cross functional teams.
• Has good analytical skills and ability to focus on the critical path and prepare mitigation strategies.
• Is adaptable and solution-oriented, ready to lead the project team to success with a high scientific standard.
• Has strong communication skills and fluency in English, both orally and in writing.
• Preferably has experience within drug development, regulatory filings and requirements.

Become a part of ALK
ALK is a global pharmaceutical company specialised in allergy immunotherapy. We are driven by a high level of professionalism, integrity, an openminded approach and contributing to an inspiring and fun working environment together with our colleagues. We provide an attractive working environment for individuals looking for both personal and professional development. You will be part of an engaged and informal team who values skill and knowledge creation.

Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm. We believe that physical presence enforces strong teamwork and collaboration and creates success, so it is important that you enjoy coming to work at our site with a degree of flexibility to also work from home. Do you want to learn more about our company, we encourage you to visit us at www.alk.net.

Apply
Apply by attaching your CV and a short letter of motivation, no later than 16 March 2025.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We evaluate applications and call for interviews on an ongoing basis, so don't wait to apply! We reserve the right to take down the advert when we have found the right candidate.

Do you have questions about the position, please contact VP, Martin Richter-Friis on +45 22 84 88 59.

We look forward to hearing from you!