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QC Manager Drug Substance for Product Supply 

Join the Product Supply Team in a leading and fast-growing biotech company

 

Ascendis Pharma is currently looking to expand its resources to support product supply in the activities of its TransCon Growth Hormone program. The manufacturing processes in the TransCon Growth Hormone program are in the commercial phase, and Ascendis Pharma is looking to hire a QC Manager within analytical chemistry to provide effective analytical coordination and support to large molecule drug substance, starting materials and intermediates. 

You will become one point of contact in analytical matters between Ascendis and specified Contract Manufacturing Organizations (CMOs). You will work to ensure continuous good relations and alignment with CMOs worldwide and stay updated with insights into their methods and processes. It is expected that in the collaboration you will contribute to areas such as analytical testing and test methods as well as regulatory guidelines and requirements on analytical validation. You will join a team of highly experienced colleagues. 

With direct report to the Director, QC Drug Substance 

Your main tasks are:  

  • Coordination between Ascendis and CMOs of analytical activities, such as technology transfer, validation strategies and supplier agreements 
  • Review and approval of analytical validation activities performed by the CMOs 
  • Review of analytical validation, release and stability testing incl. trending and control charts 
  • Facilitate and support analytical performance and efficiency improvements
  • Establish procedures for internal review and handling of analytical data for commercial manufacturing
  • Scientific and GMP-compliance review of analytical deviations and changes
  • Write regulatory documentation and follow-up on post-approval commitments to authorities
  • Keep abreast with scientific and regulatory development in areas of analytical testing, analytical methods and analytical validation 

Criteria of success in the role will be to efficiently coordinate analytical activities for the commercial manufacturing of large molecule drug substance, starting materials and intermediates for TransCon Growth Hormone. Moreover, you are expected to actively contribute to the establishment of continuous process verification programs to the annual product review process and establish close and high-standard collaborations with the CMOs.

Your qualifications are several years of documented practical analytical experience from the pharmaceutical industry within chromatographic analyses (HPLC/UPLC), either from an Analytical Development Laboratory or from a QC Laboratory. It will be an advantage if you have experience with cell-based potency assays and ELISA. Furthermore, your knowledge and experience within the analytical chemistry field will enable you to guide project teams at CMOs through conceptual as well as specific practical discussions. Preferably, you have analytical experience with analysis of large molecules, and preferably with polymers, proteins and/or peptides as well.

You have a Master’s Degree in Chemistry, Engineering, Pharmacy, or the like. 

You are proficient in English at a professional level, both written and spoken, and you master MS Office. Experience with MS Project or other project tools is an advantage. 

You are a person wita structured and systematic approach to solving tasks and possess outstanding collaboration and communication skills. As the job involves many stakeholders and coordination of activities both internally and externally, you thrive with being in contact with new people. You are a highly motivated individual who enjoys being challenged and working in collaborative environments. You possess a high energy level and focus on details when required. You have excellent abilities in terms of keeping an overview even with many active tasks at the same time.

Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in preparing Ascendis Pharma to become a pharmaceutical company with commercial production and will work with highly skilled and experienced colleagues. 

Travelling: Approx. 10-20 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 Senior Research Consultant Elisabeth Haun, Unique Human Capital on M: +45 28 90 33 88. All applications must be in English and are treated confidentially.

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