Associate Principal Scientist
Ascendis Pharma, Denmark

Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
No
Qualification
As mentioned in job details
Total Vacancies
1 Job
Posted on
Feb 26, 2021
Last Date
Mar 26, 2021
Location(s)

Job Description

Join the Drug Product Manufacturing team in an innovative and fast-growing biotech company

Ascendis Pharma is currently expanding Drug Product Commercial Manufacturing resources to support our TransCon Growth Hormone launch and to support our development pipeline. Therefore, Ascendis Pharma is hiring a passionate Associate Principal Scientist with deep insight into fundamentals of microbiology, aseptic techniques, and environmental monitoring.

You will become first point of contact within Microbiologic amp; Aseptic production matters between Ascendis and specified Contract Manufacturing Organizations (CMOs). You will work to ensure continuous good relations and alignment with CMOs and stay updated with insights into their methods and processes. You will be expected to contribute with high level knowledge about microbiologic and aseptic methods including environmental monitoring as well as high level knowledge about regulatory requirements with-in these fields. You will join a team of highly experienced colleagues and you will report to the Director of Drug Product Manufacturing.

Your main responsibilities are:

  • Assist development and commercial manufacturing as technical expert with-in microbiology, environmental monitoring, and aseptic techniques
  • Scientific and GMP-compliance review of deviations and changes with-in microbiology, environmental monitoring, and aseptic techniques
  • Review and approval of validation activities performed by the CMOs
  • Support regulatory documentation and follow-up on post-approval commitments to authorities
  • Stay updated with scientific, cGMP and regulatory development in areas of microbiology, environmental monitoring, and aseptic production in general

Criteria of success in the role will be to supervise, support and be the expert for activities with-in microbiology, environmental monitoring, and aseptic production for the commercial manufacturing of products and products in development.

You hold a relevant academic degree preferably a Master of Science in pharmacy, microbiology, or the like. You have several years (+10) of documented practical experience from the pharmaceutical industry within microbiology analyses either from an analytical development laboratory and/or from a QC laboratory and from an aseptic production environment. Furthermore, your knowledge and experience within the microbiologic and aseptic field will enable you to guide teams both internally and at CMOs through conceptual as well as specific practical issues and discussions.

You are proficient in English at a professional level, both written and spoken. As the job involves many stakeholders and some 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 in working in collaborative environments. You possess a high energy level and focus on details. 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 getting Ascendis Pharma to become a pharmaceutical company with commercial production and you will work with highly skilled and experienced colleagues within the Drug Product manufacturing and QC disciplines.

Travelling: Approx. 10-15 days per year.

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

For more details about the job or the company, please contact Thomas Bjerg on M +45 93 60 62 64 or , alternatively Lars Wæhrens on M + 45 61 61 26 91 or .

Applications will be evaluated when received, so please apply as soon as possible. All applications must be in English and are treated confidentially.

Job Specification

Job Rewards and Benefits

Ascendis Pharma

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