Stability Specialist in QC - Hellerup, Danmark - Ascendis Pharma

Beskrivelse

Do you have experience within stability studies? Are you passionate about analytical chemistry?

If so, now is your chance to join Ascendis Pharma as our new Stability Specialist.

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 Stability Specialist to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in establishing and maintaining oversight over stability studies conducted at our Contract Manufacturing Organizations (CMOs). In the longer term you could also be coordinating analytical matters between Ascendis and specified CMOs. This is an exciting opportunity to work in a fast-paced environment, collaborating with cross-functional, global teams working together to achieve extraordinary results.

You will join the Drug Product QC team of four colleagues and report directly to Director Lars Bo Ekhart Jensen, based in Hellerup.

Your key responsibilities will be:

• Establish and maintain oversight over stability studies
• Writing, reviewing, and approval of deviations and changes requests
• Writing and reviewing regulatory documentation and following up on post-approval commitments to authorities
• Support authoring of regulatory stability sections and when needed, participate in response rounds with Health Authorities
• Coordination between Ascendis and CMOs of analytical activities

Qualifications and Skills:

You hold a relevant academic degree – preferably a Master of Science in Chemistry, Engineering, Pharmacy or the like, and you have approx. 5-10 years of experience with stability studies from the pharmaceutical industry. It is an advantage if you have experience with analytical methods from either an Analytical Development Laboratory or a QC laboratory, as well as experience from working in a GMP environment.

Furthermore, you have experience with:

• Coordination and management of stability activities including management of stability programs, generation of protocols and reports, sample management and compilation of results
• Statistical analysis and evaluation of stability data
• Handling of stability OOS/OOT investigations and root cause analysis
• Performing change request assessments in relation to stability studies
• Implementation of global standards and processes for stability studies and continuous improvement projects within the Department
• Statistical principles relevant to stability studies
• Collaboration and communication with external stakeholders which will enable you to guide project teams at CMOs through conceptual as well as specific practical discussions.

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 be structured and systematic in your approach to solving tasks. As the job involves many stakeholders and coordination of activities both internally and externally, you thrive on being in contact with new people and you are proficient in English, both written and spoken.

You know how to maintain a constructive working environment and are used to work with external stakeholders to support product supply programs ensure that the stability activities are compliantly conducted and executed according to project timelines.

You enjoy having a broad network and know how to secure an acceptable compliance level at CMOs with different approaches to GMP. You enjoy sharing knowledge and participating actively in projects and cross functional meetings. It is an advantage if you have experience working with CMOs.

You are used to establishing overviews, preparing and following plans, and finding smarter ways of doing things are key goals for you.

Travel: 5-15 days per year.

Office: Denmark, Tuborg Boulevard 12, 2900 Hellerup

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 Lars Bo Ekhart Jensen, Director, , , or visit our website

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 some days a week.