Job DescriptionAbout PSC Biotech Who we are? 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.
'Take your Career to a new Level' PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/Biotech Industry. We offer a permanent contract of employment giving exposure of working in top pharmaceutical client sites in a diverse cultural work setting.
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 with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Overview: This role will require the candidate to provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes. The candidate will establish themselves in a product lead role where the majority of input provided will be leading process performance qualification (PPQ). In addition, the candidate will be expected to provide technical support to biologics drug product manufacturing at the client site as part of the global Process Development organization.
RequirementsResponsibilities would include the following: Leads new product introductions to PM2 and PM3 from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer to PM2 or PM3.Be accountable for the success of the product transfer project from initiation to the transfer, through line characterization, engineering studies, process performance qualification, and ultimately to regulatory approval.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 Change Control/NC/CAPA and technology transfer.The position will report to the Process Development Senior Engineer. Moderate international travel might be required during the course of the project.Key Responsibilities: Development of validation plans and process performance qualifications for vial and syringe filling.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) with a full understanding of CMC business processes related to technology transfer.Participate in process validation cross-functional teams at the site to ensure adherence to required policies and procedures and be responsible for delivering against organizational goals and project milestones.Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.Actively communicate across functions and sites and be a strong collaborator with all the functional groups at the receiving site, sending site, and corporate functions.Act as the responsible point of contact from the client site for the transfer project for drug product teams and Global Operations Teams.Assist in the development of any existing validation program to ensure continued compliance with the necessary regulations and input to site validation guidance documents.Collate and report on relevant shipping and filter validation.Assist in deviation and exception resolution and root cause analysis.Contribute to product quality assessments and process flow documents.Basic Qualifications: 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: Doctorate or master's 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 (PpK / batch homogeneity) and/or lyophilization processes. Knowledge of protein biochemistry with regard to 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.Confirmed the shift pattern: Its 2 days on 7am-7pm, 2 nights on 7pm-7am, 4 days off.
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