- Reference: GY43169
- Job Type: Permanent
- Location: Galway, Galway city, Mayo
- Category: Science, Pharmaceutical & Food
The R&D Principal Process Scientist will be the Subject Matter Expert (SME) that develops manufacturing platforms/processes for sterile products including liquid, sustained release and lyophile products
- Develops platform processes and controls that can support manufacture of different types of sterile products e.g.
- Potent products
- Aseptic liquids/lyophiles
- Suspensions and sustained release products
- Selection of equipment and process train for optimal manufacturing process (quality and cost)
- Application of scientific and engineering principles to develop process understanding and scale up from laboratory to commercial scale
- Nomination of process parameter ranges, set point conditions and control strategy
- Generate reports on process development and scale up for use in regulatory correspondence
2. Generates process experimental plans to define a scalable manufacturing process on laboratory/pilot scale
- Identification of unit operations (e.g. component preparation, compounding, Milling/homogenisation, filtration, transfer, filling, lyophilisation terminal sterilization)
- Nomination of process parameters
- Leads cross functional QbD evaluation for process
- Designs experiments that support nomination of a scalable process
- Execution and reporting of studies and subsequent interactions with Regulatory agencies
- Creation of GMP documentation
3. For scale up and transfer of processes to internal and third party sites. Leads and co-ordinate activities cross functionally with other R&D sites, Manufacturing, Quality and Regulatory groups.
4. Writes and supervises preparation or reports and content required for submission
- E.g. Registration batch process development, 3.P.2 sections, QbD process risk analysis
5.Ensures compliance with EHS and GMP procedures.
6. Perform other duties as assigned.
Knowledge/ experience of development and scale up of sterile/aseptic manufacturing processes for a variety of parenteral dosage forms. Experience with process development and successful scale up from laboratory/pilot to commercial scale.
SKILLS AND ABILITIES
Knowledge of sterile processing unit operations and controls, scientific and engineering principles of scale up, QbD, GMP requirements for sterile product manufacture.
Minimum of a third level Degree in Engineering or Science related discipline with a minimum of 8 years’ relevant experience with preferred experience in development, scale up and manufacture of sterile products.
However, a combination of experience and/or education will be taken into consideration.
Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with managers or directors and communicate ambiguous concepts. Ability to present to groups across the organization.
Ability to apply engineering principles and statistical tools to aid scale up.
Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.
For a confidential discussion and a more detailed job spec (more information on the role), please contact Claire O’Donnell on 091-706717 or email firstname.lastname@example.org
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