About 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 though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our clients expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met. Job Title: Tech Transfer Lead This role will require the candidate to provide process development support to new product introductions (NPI) and lifecycle changes to 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 client site as well as part of the global Process Development (PD) organization. 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. Requirements The input provided will also include support of process performance and implementation of process improvement strategies and will include the following: 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 adheres 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 to 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 bachelors degree in science, Engineering or a relevant Quality discipline with 5 years experience in a similar role OR Masters degree & 3 years of directly related experience OR associate degree & 10 years of directly related experience Knowledge of cGMPs and other worldwide regulatory requirements. Problem solving ability and excellent oral and written communications 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 skill is essential for this role. #LI-AP1
5+ years
The input provided will also include support of process performance and implementation of process improvement strategies and will include the following: · 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 adheres 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 to 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 degree & 10 years of directly related experience · Knowledge of cGMPs and other worldwide regulatory requirements. · Problem solving ability and excellent oral and written communications skills. Preferred Qualifications: · PhD 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, 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 skill is essential for this role.
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