This is what you will do:
The Manufacturing Support Team provides manufacturing support to complex life-changing biological products. The team provides a key interface between the shift operations teams and day-based cross-functional support.
The Manufacturing Support Specialist is responsible for operational support activities related to the drug substance manufacturing operations including documentation, investigations, changes, improvement projects, and supports routine day-to-day compliance for the BDS facility.
You will be responsible for:
* Perform technical writing to edit and create documents (batch records, SOPs, Work Instructions, etc.) to support Biopharmaceutical Manufacturing Operations.
* Lead, author, and coordinate Good Manufacturing Practice deviations through the quality management system. This will involve leading structured problem-solving of deviations and the identification and implementation of robust CAPAs.
* Actively monitor and trend investigation and error topics to ensure appropriate and proactive improvements are implemented.
* Raise, own, and participate in change controls while meeting the regulatory requirements defined in relevant health authority submissions, cGMPs, and local Health and Safety requirements.
* Ownership of Operations related supplier issues.
* Identify, own, and drive improvement projects for the BDS facility and its supporting processes and functions.
* Participate and/or lead risk assessments.
* Participate in inspection readiness projects and support internal audits and health authority inspections.
* Collate routine metrics.
You will need to have:
* A minimum of 5 years’ experience in Manufacturing Operations in a Pharmaceutical or Biopharmaceutical company, ideally with experience in both upstream and downstream processing.
* Good knowledge of GMP/HPRA/FDA regulatory requirements.
* Strong technical writing skills.
* Self-starter with strong communication, problem-solving, and presentation skills.
* Ability to work effectively in a cross-functional environment as well as independently on a consistent basis.
* Work collaboratively in a matrix environment.
* Proven ability to work well as part of a team and on own with minimum supervision.
We would prefer for you to have:
* BSc or MSc in Chemical Engineering, Bioscience, or Biotechnology.
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