LSC have a great contract opportunity for a Tech Transfer Lead (Junior) to join a South Dublin based Biopharmaceutical company (Confirmed shift pattern: 2 days on 7am-7pm, 2 nights on 7pm-7am, 4 days off) that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have 2 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
KEY RESPONSIBILITIES:
- Development of documentation and process design for characterisation studies, engineering runs, electronic batch record creation, validation plans, process performance qualifications for syringe filling.
- Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.
- Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards) with a full understanding of CMC business process related to technology transfer.
- Participate in process validation cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organizational goals and project milestones.
- Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
- Actively communicates across functions and sites and is a strong collaborator with all the functional groups at the receiving site, sending site and corporate functions.
- Act as the responsible point contact from ADL site for the transfer project for drug product teams and Global Operations Teams.
- Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations and input to site validation guidance documents.
- Collate and report on relevant shipping and filter validation.
- Assist in deviation and exception resolution and root cause analysis.
- Contribute to product quality assessments and process flow documents.
ABOUT YOU:
- Third level Bachelor's degree in science, engineering or equivalent discipline with 2 years experience in a commercial manufacturing or NPI role OR Master's degree & 1 years of directly related experience OR Associate's degree & 5 years of directly related experience.
- Strong technical writing skills.
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Problem solving ability and excellent oral and written communications skills.
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 Kathy Gillen on 021 4777329 if you have anymore questions about this role!
