Technical Osd Specialist
3 weeks ago
As the Technical OSD Specialist, you will also be responsible for the following:
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Technical OSD Specialist will be varied, however, the key duties and responsibilities are as follows:
Establish and develop technical relationships with CMO's and Contract Laboratories, carrying out trouble shooting activities, such as root cause analysis of analytical or manufacturing challenges.
Deliver and carry out Validation and Technology Transfer protocols, drafting and reviewing analytical transfer protocols as well as any transfer of analytical procedures.
Contribute with data management, including data for regulatory submissions, including project EMO (External Manufacturing Organisation) meetings.
Lead and support on investigations related to analytical testing and manufacturing of EMO products.
ROLE REQUIREMENTS:
Working experience of Small Molecule API's, Oral Solid Dose, Biological Drug Substances or Aseptic Filling.
2. Proven hands on experience within a pharmaceutical manufacturing, analytical testing or technology transfer.
3. A working knowledge and practical experience of external manufacturing organisations
Key Words: OSD, Oral Solid Dose, Technology Transfer, API, EMO, External Manufacturing Organisation
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