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QA Specialist with analytical and chemical process development background Job in Denmark
Ascendis Pharma , Denmark

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1 Year
0 - 0
Job Type
Job Shift
Job Category
Requires Traveling
Career Level
Master's Degree
Total Vacancies
1 Job
Posted on
Apr 7, 2021
Last Date
Jul 7, 2021

Job Description

Join the QA Development team in a leading and fast growing biotech company

Ascendis Pharma is currently expanding its QA Development resources within CMC processes and analytical development to support the development activities of its TransCon development programs. Ascendis Pharma is therefore looking to hire a passionate QA Specialist with analytical and process QA development experience to provide effective support to our Contract Manufacturing Organizations (CMOs) across development projects.

You will become responsible for the QA oversight of outsourced activities within analytical and process development, final method validation, and stability testing and other process activities for Starting Materials, Intermediates and Drug Substance. Additionally, you will work to ensure continuous good relations and alignment with CMOs/CROs worldwide and stay updated with insights into their methods and processes. You will join a QA Development department of 17 highly experienced colleagues, and you will report directly to the Associate Director for QA Development, chemistry. The QA Development, Chemistry-team is a strong social team with a good sense of humor and you will be welcomed by a team of 5 wonderful colleagues.

Main areas of responsibility:

  • CMO responsibility regarding Compliance amp; Quality
  • Review and approval of validation and stability protocols/reports
  • Perform batch record review for both manufacturing and analytical processes
  • Handle change requests and deviations
  • Act as support to the CMC teams within Ascendis Pharma regarding analytical subjects as well as GMP manufacturing
  • Ensure the internal quality management system within CMC development is developed and maintained
  • Develop and implement GxP improvement projects for systems and procedures including SOPs, policies, forms, and tools
  • Identify and communicate quality or compliance risks and participate in establishent of appropriate plans to address the risks
  • Schedule, plan and perform CMO and CRO audits
  • Audit internal processes, submission documents etc. in accordance with the audit plan or as requested.
  • Establish quality agreements with CMOs

Criteria of success in the role will be to review and approve analytical and stability documentation from CMOs to support establishing reliable and robust analytical methods as well as supporting the GMP manufacturing processes. Moreover, you must contribute actively to the project teams regarding QA support within analytical method validation and stability. Furthermore, you should also establish close and high-standard collaborations with the CMOs that Ascendis Pharma works closely with and be a value-adding resource to them in order to assure a high-quality level

You hold a relevant academic degree preferably a Master of Science in Chemistry, Engineering, Pharmacy or the like. You have several years of documented experience within QA development and/or practical analytical experience from the pharmaceutical industry within chromatographic analyses (HPLC/UPLC, LC-MS, SE-HPLC), bioassays, compendial methods and microbiological testing. Furthermore, your thorough knowledge and experience within the relevant GMP guidance/legislation will enable you to guide and advice project teams at CMOs to the appropriate operational GMP level.

You are proficient in English at a professional level, both written and spoken, and you master MS Office.

You are a highly motivated individual who enjoys being challenged and working in collaborative environments. Strong interpersonal skills are necessary as you will serve as a major contributor and trusted member of the project development teams. A proven ability to communicate with other development staff in a fast-paced environment is crucial. Finally, attention to detail is a prerequisite, as well as a high energy level, focus, and a passion and sense of urgency for developing important new medicines for devastating diseases.

Ascendis Pharmaoffers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy and work with highly skilled and experienced colleagues to advance our exciting product pipeline.

Travelling: Approx. 20 days per year.

Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view to the harbor, the canals, and the sea.

For more details about the job or the company, please contact Associate Director, QA Development, Jon Wriedt Poulsen, M +45 51 70 60 23. All applications must be submitted in English and are treated confidentially.

Job Specification

Ascendis Pharma

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