Job Description
Lead, coach and mentor your teamBe responsible for the supervision and execution of filling, lyophilization, equipment preparation, formulation, buffer preparation and support processing activities in the biologics fill finish facility to meet clearly stated operating objectives.Promote a culture of contamination control and compliance with aseptic best practice.Liaise with functional leadership teams (Ops, Quality, Engineering, Supply Chain etc) on operational activitiesDaily reporting on the status of all operations and support activities.Provide clear and concise communication to your team on their tasks and goals so that they can work effectively.Provide technical expertise for investigation and resolution of process deviations, root cause investigation, CAPAs, process improvements, review and approval of change controlsResponsible for verification and update of manufacturing control system transactions accurately and in a timely fashion.Act as key point of technical contact for aseptic fill finish activities.Liaise with program management, supply chain, technical operations quality and engineering groups to ensure effective planning, scheduling and execution of commercial and NPI clinical manufacturing.Responsible for driving operations excellences and Key operations targets including OEE where applicable.Provide direct interface as a subject matter expert with QA department to interaction with HPRA, FDA and applicable health authority and internal audits.Lead cross functional risk assessments and continuous improvement projectsEnsure the execution of fill finish, lyophilization, equipment preparation, buffer preparation and formulation processing activities to meet clearly stated operating objectives.Responsible for manufacturing compliance with all safety, environmental and quality related SOPs.Drive safety improvements and initiatives across the operationPromote a culture of Right First Time, Behavioural Based Safety, Always Audit Ready and Human Error Reduction within their team.Work closely with the other Technical Shift Leaders to ensure interdepartmental activities are planned and executed safely.Requirements
You will have a Degree, Masters or PhD in Life Sciences, Process Engineering, Biopharmaceutical Engineering or Chemical Engineering disciplineWith 5 + years experience in batch processing, automation, commissioning and validation in an FDA/HPRA regulated industry and 1+ years team leadership experienceDetailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.Comprehensive understanding of the principles of contamination control and regulatory expectations for aseptic processing.Has a technical background in pharmaceutical, biologics, or similar industriesExperience of start-ups and/or new product introductions to bio-pharmaceutical/pharmaceutical facilities (Biologics Preferred)Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality and safety requirements.
