LSC have a great contract opportunity for a Process Development Specialist to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Assess product impact associated with proposed changes to commercial processes under the change control process.
- Generate product impact assessments associated with process excursions and deviations, with reference to product technical documentation.
- Support new product introduction team, as a process subject matter expert; This would include but is not limited to, recipe development and protocol execution, as well as troubleshooting and investigation support.
- Review and approve changes to operating procedures, electronic batch records, and product documentation.
- Identifies and implements operational opportunities for current and new sterile operations
- Risk assessments and mitigation projects relating to line performance.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Typically 4-6 years drug product experience in areas such as drug product formulation, vial/pre-filled syringe filling or lyophilisation
- Qualification in Lean and 6-sigma methodologies would be an advantage.
- New product introduction (NPI), process development, MSAT experience in a GMP environment would be advantageous.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Adam Murphy on 021 4777329 if you have anymore questions about this role!
