Senior QA Specialist / QA Specialist

Job title:

Senior QA Specialist / QA Specialist

Company:

Ascendis Pharma

Job description

Passionate about Quality Assurance with expertise within QC Analysis?Ascendis Pharma invites you to explore the role of our newest QA Specialist / QA Senior Specialist for QC.With roots spanning Denmark, Germany, and the United States, Ascendis Pharma A/S emerges as a innovative and dynamic biopharmaceutical Company. Powered by our innovative TransCon technology, we’re creating a fully integrated biopharmaceutical enterprise dedicated to transforming the life of patients. Guided by our core principles of patients, science, and passion, we leverage our TransCon drug development platform to pioneer new therapies addressing critical medical needs. Our pipeline consists of several therapies, each designed to set new standards in patient care.We’re on the lookout for a dedicated QA Specialist, or Senior Specialist – depending on qualifications, to join our highly skilled QA team in Copenhagen. As a vital contributor at Ascendis Pharma, you’ll play a pivotal role in ensuring the QA oversight of the analytical development carried out at our Contract Laboratories and Manufacturing Organizations, working in a dynamic environment alongside global teams to achieve our final goals to deliver best in class products to our Clinical programs remarkable outcomes.You’ll become part of the Development QA – Chemistry team, working closely with 10 close colleagues and reporting to Director Jon Wriedt Poulsen, based in Hellerup, Copenhagen, Denmark, where your home base will also be.Your main responsibilities will include:

• Responsible for driving the Analytical Quality Oversight for one specific project but also collaborating and contributing to the ongoing work at different other projects in our development pipeline
• Responsible for Quality Oversight of our outsourced analytical procedures at Contract organizations located all over the globe, including the complexity that such outsourcing activities add to an already complex analytical scope.
• Sparring with the team of highly skilled Analytical SMEs in the CMC department that drives the analytical development, both in-house but also at our Contract Organizations and guiding them in quality related topics.
• General support the quality work and quality oversight needed for a fast-paced development organization.

Qualifications and Skills:

• You should hold a relevant academic degree, preferably a Masters degree in Pharmaceutical sciences, Chemistry, Biotechnology, engineering or equivalent with more than 5 years of experience in analytical work in a GMP environment.
• Accustomed to working with outsourcing of analytical methods and analytical development
• Knowledgeable with requirements set out by different health authorities and interpretation of these

Key Competencies:

• You’re a team player, analytical, and approach challenges with a positive and constructive mindset.
• You thrive in an environment where innovation and adaptability are valued and required.
• To excel in this role, we expect you to be proactive, dare to take prompt decisions, and understanding when to involve and escalate if deemed necessary.

Travel: proximately 20 days per year.Office: Tuborg Boulevard 12, 2900 Hellerup, Copenhagen DenmarkApply now.Applications will be reviewed as they are received, so please apply promptly.All applications must be submitted in English and will be treated confidentially.

Expected salary

Location

København

Job date

Sat, 27 Apr 2024 22:45:34 GMT

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