Industry: Pharma/Biotech/Clinical Research Work Experience: 5+ years City: Dublin State/Province: Dublin Country: Ireland Job DescriptionAbout PSC Biotech PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
Employee Value Proposition Employees are the "heartbeat" of PSC Biotech; we provide unparalleled empowering career development through Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client's expectations regarding the quality of all scalable and business unit deliverables, staying under budget, and ensuring timelines for our deliverables are being met.
This role will require the candidate to provide process development support to new product introductions (NPI) and lifecycle changes to the site, provide subject matter expertise for unit operations, and support ongoing production. The candidate will provide technical support to large molecule and small molecule drug product manufacturing at the client site as well as part of the global Process Development (PD) organization. The client is currently operating with one RABS vial filling machine and one syringe filling machine.
Two major projects are ongoing: one to introduce an Isolator Vial Fill Line which is now in its qualification phase, and two, the significant increase in output volume from the Syringe Fill Line. Successful applicants will be directly involved in these projects.
RequirementsFunctions: Leads new product introductions and lifecycle changes into Vial filling and Syringe filling from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer.Be a key contributor to regulatory filings as part of the NPI process throughout the authoring, editing, and submission process but also be responsible for response to regulator questions as and when required.Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation for parenteral products through the NPI or post-NPI phases.Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer, and validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.Develops and characterizes drug product processes and transfers technology to commercial drug product sites.Identifies and implements operational opportunities for current and new sterile operations.Troubleshoots issues with drug product processing technologies and equipment.Leads and conducts risk assessment for drug product operations and propose/implement appropriate CAPA.Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.Development and execution of validation plans, process performance qualifications (PPQs) for vial and syringe filling with a cross-functional team.Ensuring all aspects of activity within any given process validation adhere to required policies and procedures, including safety and training.Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards).Assist in the development of any existing validation program to ensure continued compliance with the necessary regulations.Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.Contribute to product quality assessments and process flow documents.Liaise with Operations, Engineering, and external vendors regarding new or amended equipment which would impact the validated product.Lead or assist in deviation and exception resolution and root cause analysis.Participate as required in project activities and be developing own project management techniques.Basic Qualifications: A third-level bachelor's degree in science, Engineering or a relevant Quality discipline with 5 years' experience in a similar role OR Master's degree & 3 years of directly related experience OR Associate's degree & 10 years of directly related experience.Knowledge of cGMPs and other worldwide regulatory requirements.Problem-solving ability and excellent oral and written communication skills.Preferred Qualifications: PhD or Masters in Science or Engineering.5+ years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation.Strong skills in applying fundamental engineering and scientific principles to the design, implementation, and process validation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes. Knowledge of protein biochemistry regarding chemical and physical stability.Project management skills including the ability to manage multiple projects and evaluate project resource requirements.Strong knowledge of Quality systems, Drug Product Manufacturing, and Validation.Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent communication skills are essential for this role.
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