QA Specialist for Development projects
Are you passionate about a wide collaboration? Do you have experience within analytical methods and are you driven to be part of a dynamic and ambitious company? If so, now is your chance to join Ascendis Pharma as our new QA Specialist.
We are looking for a highly motivated QA Specialist to support Ascendis Pharma’s development programs of TransCon Product’s. As QA Specialist you will become responsible for QA Oversight of outsourced activities within analytical and process development for chemically manufactured Intermediates and Drug Substance. You will work closely with stakeholders across the organization to align on the development strategy. At the same time, you play a key role in the CMC development project groups, with focus on ensuring continuous good relations and alignment with the CMO/CRO's worldwide and ensuring quality compliance with EU and US regulations and guidelines.
Main area of responsibility:
- Support the CMC development groups within analytical subjects as well as GMP manufacture for clinical trials.
- CMO responsibility regarding compliance and quality.
- Review and approval of analytical methods, validation and stability protocols/reports.
- Perform batch record review for both manufacturing and analytical processes.
- Handle change request and deviations.
- Prepare for batch release to clinical trials and ensure compliance to regulatory submissions.
- Ensure the internal quality management system within CMC development is developed and maintained.
- Perform audits of CMO/CROs worldwide.
Ascendis Pharma is a leading and fast-growing biotech company with a dynamic and ambitious QA Development department that consists of 30 highly experienced colleagues. You will be working in QA Development, Chemistry – Intermediates & DS consisting of 3 team members, who add positively to the strong social mindset and humor of the QA Development Department. In the position as QA Specialist, you will report to the Associate Director for QA Development, Chemistry – Intermediates & DS.
The ideal candidate has a strong scientific background (MSc in relevant scientific field such as chemistry, pharmacology, or biology) with several years of experience from the pharmaceutical or biotech industry. You should be curious, ambitious, and driven to make a difference in a fast speed company. In addition, the Ideal candidate has a structured and analytical approach. The job requires that you can challenge and be responsive and pragmatic in identifying solutions, together with being proactive, and foster strong relationships within a diverse organizational culture.
Travel: expected to be 15-20 days per year.
Place of work: Ascendis Pharma headquarter resides in a modern and wonderful office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals, and the sea.
All applications must be submitted in English and are treated confidentially. Applications will be evaluated when received, so please apply as soon as possible.