LSC have a great contract opportunity for a Manufacturing Technology Specialist to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
If you have 5 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!
ABOUT THE PROJECT - KEY RESPONSIBILITIES
- Downstream (Purification Focus): to include buffer preparation, purification and viral reduction steps, including chromatography, ultrafiltration, viral reduction filtration and viral inactivation technologies and DS formulation and bulk fill.
- To identify and implement process improvements, e.g. yield, cycle time reduction through evaluation of process performance using data analytics tools.
- Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies (e.g. health authority query support - timely responses / data gathering etc.).
- To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution.
- Identify or support process improvements (through change control or CAPA) and participate in implementation of Lean initiatives on site.
- Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process.
ABOUT YOU - ARE YOUR SKILLS A MATCH
- Minimum BSc or equivalent with at least 5 years' experience in drug substance manufacturing technical support in the biopharmaceutical industry.
- You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.
- Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organization, and in local group settings.
- Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.
- Can effectively partner with and influence stakeholders without direct solid line authority. Drives technical decisions balancing product quality and operational requirements.
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 any more questions about this role!
