Job Description
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. #J-18808-Ljbffr