Scientist Drug Product

Scientist Drug Product

Ascendis Pharma

Hellerup, Denmark

Description:

As Scientist Drug Product at Ascendis Pharma the primary tasks are to ensure that our commercial Drug Products are produced and delivered in accordance with current legislations and approvals. You will take part in ensuring a smooth tech-transfer from Development to Commercial Manufacturing and to establish close and high-standard cooperation with the CMOs used by Ascendis Pharma for commercial aseptical produced Drug Products. Additionally, tracking of process performance will be an important part of the work.

You will take part in securing our supply of commercial manufactured drug products. Moreover, you will take part in consolidating and documenting the validated state.

The position reports to the Director of Drug Product Manufacturing and the candidate will be a part of a highly dedicated and experienced team.

The main responsibilities are:

• Supporting internal specialists in securing and documenting the validated state of our commercial drug products;
• Supporting validation of transportation activities;
• Involved in authoring regulatory documentation for filing in new countries;
• Supporting manufacturing activities at the CMOs, including follow up on deviation, changes, production metrics, CPV activities and optimization projects;
• Support inter-departmental communication and ensure effective handoffs to execute on important project milestones;
• Ensure manufacturing metrics are established and reported.
• You hold hold a relevant university degree-preferably a Masters of Sciences, Pharmacy, Engineering, or the like;
• The successful applicant will have a proven record of working within the aseptic processing field and preferable with a track record of hands-on aseptic processing and documentation. The following qualifications are appreciated:
  • A minimum of 3 years of experience within the field of drug product manufacturing from the pharmaceutical industry;
  • Experience within aseptic processing;
  • An analytical mindset and ability to troubleshoot complex issues;
  • Experience within regulatory and QA requirements (EMEA and FDA regulations) for drug product to be manufactured for market supply;
  • Ability to manage details and at the same time ensure a holistic approach towards all steps in the manufacturing process including analyses and regulatory impact.
• You are proficient in English and Danish at a professional level, both written and spoken, and you master MS Office;
• You are a personwho has apersonal commitment to delivering results. You are analytical and science-driven, and you identify and resolve problems in a timely manner. You are a flexible, adaptable, and robust person with a hands-on attitude. You are pragmatic with an open and communicative approach and with the ability to develop effective working relationships with employees at all levels. You can handle and deliver on routine jobs, while at the same time having the ability to move projects forward.

Apply Now

More Job Searches

Denmark      Clinical Research      Manufacturing and Logistics      Quality Assurance      Regulatory Affairs      Ascendis Pharma