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.

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

Functions:

• 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 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 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 crosssite 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.
  
• Preapprove and postapprove 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 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 freezethawing 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 crossfunctional teams to advance complex projects to completion. Excellent communication skill is essential for this role.