Upstream Technical Expert

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics) - 8 Tuas Bay Lane Singapore

Job Purpose
 
Responsible for technology transfer activities at site level. -Leads technical transfer project team at site and liaises efficiently with involved functions (e.g. Development, Supply Chain, Production Unit, Quality Control, HSE, other sites).
 
Key Responsibilities
 
  • Support the transfer of new products on site and the manufacturing sciences and technology oversight of commercial processes being manufactured.
  • Evaluate the applicability of new upstream processes on site with detailed facility fit assessments and process improvement initiatives.
  • Ensure the implementation of new processes in routine production in collaboration with the tech transfer team and all internal site stakeholders.
  • Assist the Process Sciences Team as necessary in the design and execution of experiments within the small scale and pilot scale labs.
  • Perform site support for scale-up, optimization and validation of upstream processes and commercial support of all commercial manufacturing campaigns.
  • Assist the Process Sciences, Tech Transfer and Validation teams in the technical oversight for ongoing process monitoring (OPM) and ongoing process verification (OPV) activities throughout the product lifecycle.
  • Provide manufacturing with critical information for maintaining consistent process robustness and manufacturing reliability
  • Provide continuous support for troubleshooting and improvement of existing processes and equipment for Quality System assessments and product impact assessments.
  • Assist as necessary in the preparation of protocols and study procedures (including statistical process control, method transfer and process and equipment validation)
  • Provide technical oversight and support to the process science labs for investigations, projects / studies that support Tech Transfer and Commercial Manufacturing support (including planning and execution of operations at laboratory and pilot scale).
  • Participate in drafting of documentation for regulatory submissions and provides technical expertise for site audit support.
  • Provide technical support for global BioProduction Ops initiatives and participate in the driving implementation of best practices and information sharing across global MS&T groups.
  • Provide training within MS&T and the Production Unit local and globally in areas relevant to upstream processes and platform improvements.
  • Act as a role model in accordance with the Novartis Values and Behaviors and established leadership standards.
  • Drive a culture of health & safety and compliance and adhere to all related procedures.
 
Requirements
 
  • Min Bachelor Degree in Biotechnology, Biochemical Engineering or related discipline.
  • Min. 8 years’ experience in Cell culture late stage process development, MS&T or cGMP production support.
  • Thorough understanding of manufacturing processes and related process equipment.
  • Experience in supporting large scale manufacturing support required.
  • Experience in process transfer, scale up and site licensure desired.
  • Intermediate level of statistics knowledge and expertise desired.
  • Experience in regulatory submission review and support, inspection readiness and routine audit interaction desired.
  • Strong experience in reviewing and writing technical reports, regulatory and validation documents.


Post Date 14 December 2017
End Date 28 December 2017

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Company Profile

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics)

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics)

Singapore - West - Tuas

Novartis BioProduction Operations Singapore is a new entrant to the Singapore biologics sector. Our facility will focus on drug substance manufacturing based on cell culture technology. The site is designed to handle small and large scale volumes to support both clinical and commercial production of potential new products.