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Drug Product MSAT Scientist

  1. Denmark
Denmark
  1. Contract
Competitive
  1. Life Sciences
19-01-2021
25567/ZM

This vacancy has now expired

Drug Product MSAT Scientist - Denmark

Denmark is a hive of activity for the Life Sciences Industry at present with no shortage of major expansion/ new build facilities. We have an exciting opportunity for a Drug Product MSAT Scientist to join a major project for a global biotech organisation, located in Denmark, with great longevity of employment possibility.



Key Responsibilities:
  • Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for the Drug Product facility.
  • Specific focus will be on the drug product until operations – secondary, fill finish and label & pack.
  • Investigation and resolution of process deviations, root cause investigations, CAPAs, process improvements, change controls and preparation of regulatory filings.
  • Strong knowledge of cGMP compliance, site and regulatory agency requirements.
  • Assists in evaluating process performance by comparing manufacturing data to historical data from other sites.
  • Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process.
  • Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the site.
 

This job might be for you if you have:
  • Minimum BSc or equivalent with at least 5 years’ experience in Drug Product manufacturing technical support ideally in the biopharmaceutical industry including experience with process validation.
  • Previous experience acting as a process SME within the drug product unit operations within a biopharmaceutical manufacturing facility.
  • You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.
  • Excellent verbal & written communications skills. Interpersonal and facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams.
  • You have proven problem-solving ability, project management skills, including leading cross functional teams and balancing multiple project assignment
 


For more information on this project/position, please apply with a copy of your up to date CV today! 




The candidate must have the rights to work in the location stated in the job advert.

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