QC Project Manager

Ascendis Pharma

Ascendis Pharma

Operations
2900 Hellerup, Denmark
Posted on Tuesday, December 5, 2023

Are you passionate about analytical chemistry/Quality Control (QC)? Do you have experience within project management?

If so, now is your chance to join Ascendis Pharma as our new QC Project Manager.

Ascendis Pharma is a fast-growing biopharmaceutical company with locations in Denmark, Germany, and the United States.

We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives. Guided by our core values of patients, science, and passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Today, we have a growing pipeline of prodrug therapies in development, each designed to be a best-in-class therapy.

We are seeking a passionate QC Project Manager to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in coordinating analytical matters between Ascendis and specified Contract Manufacturing Organizations (CMOs). This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results.

You will be joining the QC Biologics team consisting of eight colleagues, and report directly to Vibeke Sønder, Senior Directorwho is based in Hellerup. You will be based in Hellerup.

Your key responsibilities will be:

  • Coordination between Ascendis and CMOs of analytical activities, such as technology transfer, validation strategies and supplier agreements
  • Review and approval of analytical validation activities, deviations and changes performed by the CMOs
  • Oversight of release and stability testing incl. trending and control charts.
  • Establishment of procedures for internal review and handling of analytical data for commercial manufacturing
  • Writing and reviewing regulatory documentation and following up on post-approval commitments to authorities

Qualifications and Skills:

You hold a relevant academic degree – preferably a Master of Science in Chemistry, Engineering, Pharmacy or the like – and 5-10 years of documented practical analytical experience from the pharmaceutical industry within chromatographic analyses, either from an Analytical Development Laboratory or from a QC Laboratory.

Furthermore, you have:

  • Analytical experience with analysis of proteins and/or larger molecules
  • Knowledge and experience within the analytical chemistry field which will enable you to guide project teams at CMOs through conceptual as well as specific practical discussions
  • Outstanding collaboration and communication skills

Key competencies:

You are a strong team player, analytical, and have a can-do attitude.

You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.

To succeed in this role, we also expect you to work with a structured and systematic approach to solving tasks. You are proficient in English at a professional level, both written and spoken, and you master MS Office. As the job involves many stakeholders and coordination of activities both internally and externally, you thrive with being in contact with new people.

Travel: 10-20 days per year.

Office: Denmark, Tuborg Boulevard 12, 2900 Hellerup

Apply now.

Applications will be evaluated when received, so please apply as soon as possible.

All applications must be submitted in English and are treated confidentially.

For more details about the position or the company, please contact Vibeke Sønder, Senior Director, +45 5127 77688 or visit out website www.ascendispharma.com

Benefits

  • You can expect an attractive remuneration package, short- and long-term incentives, pension scheme and health insurance.
  • Laptop, iPhone, paid internet, and home office equipment
  • A thorough and structured onboarding program
  • To succeed in your job and expand in your role, you and your manager will continuously have Impact conversations about how to propel your development. If a need is identified, we find a way to help you grow.
  • Soft drinks, fresh fruit and lunch every day in our canteen.
  • Ascendis Pharma headquarters resides in a modern and bright office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals, and the sea.
  • To ensure a balanced approach to the office, all employees have the opportunity to work from home up to two days per week.