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QC Manager with project coordination and transfer experience

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 PPQ stage and approaching the commercial phase. Therefore, Ascendis Pharma is looking to hire a QC Manager within Analytical Chemistry to ensure a smooth tech-transfer from Development to Commercial Manufacturing. Furthermore, the QC Manager will participate in the establishment of QC performance tracking tools in order to ensure high quality of the commercial manufacture and in the establishment of close and high-standard cooperation with the CMOs used by Ascendis Pharma.

As QC Manager you will be responsible for QC drug substance for a late stage project. Furthermore, you will assume the responsibility for the activities related to QC for the commercial manufacturing process including establishment of QC performance tracking tools. You will participate in the outline of pre-launch activities and post PPQ activities at the CMOs that manufacture intermediates and drug substance. You will use your experience within the fields of biologics drug substance analysis as well as late-stage development to guide and drive the process for having drug substance analysis performed in a timely manner.

You will become one point of contact in analytical matters between Ascendis and specified CMOs. You will work to establish and 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 in areas such as analytical testing, test methods, tech transfer as well as regulatory guidelines and requirements on analytical validation. You will join a team of highly experienced colleagues and you will report to the Director, Quality Control (QC).

Criteria of success in the role will be to coordinate analytical activities for the commercial manufacturing of large molecule drug product 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. You must take ownership for establishing and maintaining a successful and smooth collaboration with Ascendis colleagues and with the CMOs. Moreover, you will actively contribute with your analytical knowledge to further build up Ascendis’ QC capabilities.

Your main responsibilites are:

  • Coordinating analytical activities between Ascendis and CMOs
  • Responsibility for coordination of project related activities, when projects are tranferred internally and externally
  • Ensuring a smooth tech-transfer from Development to Commercial Manufacturing and betweeen different CMOs
  • Establishing QC performance tracking tools
  • Scientific and GMP-compliance review of analytical deviations and changes
  • Reviewing and approval of analytical validation activities performed by the CMOs
  • Reviewing analytical validation
  • Facilitating and supporting analytical performance and efficiency improvements
  • Establishing procedures for internal review and handling of analytical data for commercial manufacturing
  • Writing of regulatory documentation and follow-up on post-approval commitments to authorities
  • Keeping abreast with scientific and regulatory development in areas of analytical testing, analytical methods and analytical validation

You hold a relevant academic degree – preferably a Master of Science in Chemistry, Engineering, Pharmacy or the like. You have several years of documented practical analytical experience from the pharmaceutical industry within chromatographic analyses (HPLC/UPLC, LC-MS, SE-HPLC), either from an Analytical Development Laboratory or from a QC support laboratory. It will be an advantage if you have experience with cell-based potency assays and ELISA, and if you have experience with the commercial setup of stability studies. 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 experience with analysis of large molecules, and preferably with polymers, proteins and/or peptides as well. Furthermore, it will be an advantage if you have experience with tech transfer from development to commercial manufacturing, tech transfer between different CMOs and QC performance tracking tools.

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

You have a structured and systematic approach to solving tasks. 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. You have excellent abilities at keeping an overview 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: 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 Consultant Louise Nielsen, Unique Human Capital on M: +45 29 74 24 24 or Research Consultant Elisabeth Haun, Unique Human Capital on: elh@uhc.dk. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
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cvr: 31502705
Stamholmen 157
2650 Hvidovre
Skelagervej 375E
9000 Aalborg
Søren Frichs Vej 42R
8230 Aabyhøj
Unique Human Capital Poland Sp. z o.o.
ul. Gie³dowa 4a, lokal 191
01-211 Warszawa
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