Senior Tech Transfer Lead

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 cloudbased 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 point which includes the opportunity to work with the most talented cohort of likeminded 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 diversecultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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 of process performance qualification (PPQ). In addition the candidate will be expected to provide technical support to biologics drug product manufacturing at client site as part of the global Process Development organization.

Requirements

Responsibilities 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 success of the product transfer project from initiation to the transfer through line characterisation engineering studies process performance qualification and ultimately to regulatory approval.
  
• Provide solutions when trouble shooting drug substance freezing/thawing formulation filling vials/syringes/devices lyophilisation inspection and transportation for parenteral products through the NPI or postNPI 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 Process Development Senior Engineer. Moderate international travel might be required during the course of the project.
  

Key Responsibilities:

• Development of validation plans process performance qualifications for vial and syringe filling.
  
• 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) with a full understanding of CMC business process 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 to deliver against organizational goals and project milestones.
  
• Preapprove and postapprove process validation protocols and assessments from a quality system documentation perspective.
  
• Actively communicates across functions and sites and is a strong collaborator with all the functional groups at the receiving site sending site and corporate functions.
  
• Act as the responsible point contact from 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 to 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 communications 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 freezethawing filtration mixing filling (PpK / batch homogeneity) and/or lyophilisation 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 crossfunctional teams to advance complex projects to completion. Excellent Communication skills are essential for this role.
  
• The successful candidate will need to be prepared to participate in 24/7 support approx.
  
• Confirmed the shift pattern: Its 2 days on 7am7pm 2 nights on 7pm7am 4 days off.
  

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