CMC Project Manager

CMC Project Manager

Can you understandably convey complex information to many stakeholders while ensuring that all activities and processes in CMC development run smoothly?

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As CMC Project Manager at Adcendo, you will be project-responsible for CMC development from the process and analytical development to supplies for clinical trials, initially the GCP1 project. In addition, you will facilitate team collaboration to identify risks, challenges, and opportunities within CMC for pipeline projects.

With direct report to Chief Technology Officer.

Your main tasks include, but are not limited to:

• Lead activities and establish plans for the CMC development within pipeline projects
• Ensure efficient collaboration with internal and external stakeholders
• Collaborate with non-clinical and clinical supply and supply chains to ensure supplies for all programs
• Contribute to the formulation and analytical development, and manufacturing process development
• Responsible for vendor selections, oversight, and evaluation of CDMOs
• Review manufacturing and analytical documentation
• Review stability data and establish shelf line in collaboration with QA
• Review and approve protocols, development reports, batch records, standard operating procedures (SOPs), and other technical reports to support regulatory filings

Your qualifications are 7-10 years of experience working in the industry with CMC-related projects and belonging activities. You have experience with developing biopharmaceutical products and in pharmaceutical development, e.g., manufacturing, analytical development, and project management.

You are experienced in supplier management and all aspects of vendor management. You have worked in a GMP-regulated environment and possess a track record of problem-solving capabilities in pre-clinical and clinical drug development.

You hold a relevant academic background in Science, such as Pharmacist, Chemist or Engineer.

You have a problem-solving and intuitive approach to challenges and hold significant autonomy regarding the work approach. You can work independently and make your own decisions but also deviate when to include others.

You are a decision-maker, intuitive, passionate, and curious about your field of expertise. You can work detail-oriented but also show courage in various decisions and approaches.

Adcendo is a science-driven and quality-based company offering an interesting position in a growing team of dedicated and passionate employees. Adcendo values trust, dignity, respect, transparency, and open communication. The individuals’ results are high on the daily agenda. Working at Adcendo, you will experience room for your ideas with great possibility to impact and influence various processes and tasks, space for individual development, and an all-time highly oriented focus on an inquisitive work environment, where work-life balance is prioritized, and where you take part in making a difference in a meaningful and essential area.

Travelling: Approx. 10 days per year.

Domicile: In commuting distance to the office in Copenhagen. With some flexibility to work from home.

For more details, please contact Director Life Science Gert Vium Andersen, Unique Human Capital on M: +45 42 95 08 83. All applications must be in English and are treated confidentially.