Title: Manufacturing Operations Lead

Summary:
The Operations Lead will serve as primary production process owner responsible for New Product Introduction and Life Cycle Management Projects and process improvements projects. They will be operations point of contact for coordination of the manufacturing effort and will be responsible for driving process efficiencies as part of the project for operations. They will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to ensure streamlined manufacturing operations are enabled in both vial and syringe manufacturing facilities.

Responsibilities:
* Function as the site interface between the Product Delivery Teams (PDT's), and Manufacturing operations.
* Develop, review, and approve generic batch records and parameter value lists across Formulation, Filling, and Inspection.
* Develop, review and update Production, Engineering, Operating Procedures & training materials.
* Assist in providing training on scientific or technical aspects of the process/project.
* Evaluate, plan, and implement solutions for process improvement opportunities.
* Support scheduling and execution of Characterisation, Engineering and PPQ runs including ensuring all necessary pre-requisites are included on the schedule and assess process performance by observation of floor operations and review of performance data.
* Provide troubleshooting support throughout the project and on the floor during execution of activities.
* Hold people to account for delivery and behaviours within Product team.
* Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing.
* Partner with Learning & Performance to define training strategy's for NPI's and complex projects.
* Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current SOP's, batch documentation and licences.
* Develop, review and update Protocols for manufacturing activities.
* Documentation and approval of protocol deviations for manufacturing activities.
* Liaise with Process Development regarding process changes in an effective and timely manner.
* Own and lead change controls as required by the NPI Project Team.
* Review and approve bills of materials.
* Develop, review and update Product Quality Risk Assessments.
* Contribute and assist with corporate, FDA, HPRA and other regulatory bodies during company audits.

Qualifications and Experience:
* Bachelor's degree in a science discipline.
* Knowledge of relevant regulations and regulatory requirements (GMP, EH&S).
* 3+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry.
* Project Management and organizational skills, including ability to follow assignments through to completion.
* Problem solving skills: Gathers data from key stakeholders, analyses and interprets information to develop solutions to technical problems of moderate complexity.
* Negotiation and Influence skills.
* Take initiative to identify and drive improvements.
* Excellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skills
* Escalate issues professionally and in a timely manner.
* Decision Making skills and confidence to challenge others on decisions that impact the manufacturing area.
* Ensures compliance within regulatory environment.
* Demonstrated ability to work independently and deliver right first-time results under minimal direction.

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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.