This role is a Person-in-Plant position based at SK bioscience (Andong), Sanofi’s CMO partner.
Report to MSAT Drug Substance Head Viro & Bacterio CoE - MLE (France)
Direct report to this position : None
THE POSITION
The Scientific Liaison, or Product Process Specialist (SPP), for Pneumo conjugate vaccine is a member of the Manufacturing Technology group of Sanofi Vaccines and supports the process knowledge and life-cycle management of Bacterial vaccines. This includes expertise in the production of drug substance and drug product, manufacturing assistance, and improvements in process and testing. The Associate SPP is recognized as a primary point of contact and a technical contributor for troubleshooting non-conformance occurrences in manufacturing at Sanofi’s Partner in South Korea as well as a member of process improvement and new process implementation teams.
RESPONSIBILITIES
Make the link with sanofi CMC team on the Partner site to allow successful delivery of the different CMC CTD section required for initial submission
Subject matter expert / technical expert for production of Pneumo conjugate family of vaccines, life-cycle improvements, and testing at Sanofi’s Partner in South Korea.
Recognized as a point of contact and technical contributor for troubleshooting non-conformance occurrences in manufacturing and supporting their on-time resolution.
Support tech transfer, scale-up, and process validation of processes to support project objectives
Facilitate process monitoring, trend analysis, and investigations required for batch disposition, resolution of non-conformances and input to product life cycle. Must demonstrate the ability to critically analyze data from complex systems and recommend efficient courses of action for resolution.
Propose opportunities for application of new technologies or process to existing platform to improve productivity, throughput, purity, quality, and/or compliance.
Review and approve user requirements for manufacturing equipment.
As a member of the CMO support team, effectively communicate status, risks, and opportunities to departmental or global partnership management and/or the project team.
Provide technical support for regulatory submissions and reviews and maintain knowledge in technological advancements and regulatory trends applicable to the area of expertise.
Work closely with other members of the department to share knowledge and competencies.
MUST HAVE QUALIFICATION
Bachelors or Masters in basic biological sciences, engineering, or pharmacy with 6+ years’ experience or PhD with 1+ years’ experience in biological processes or analytics in a cGMP environment. Candidate should possess educational and professional experience, commensurate with the position.
Expertise in Bioprocesses with knowledge of both drug substance and drug product operations
Excellent written and oral skills in Korean and English
Expertise in large scale equipment setup, troubleshooting and maintenance
Has ability to work under very tight timelines while understanding the priority of the business and deliver results.
Strong interpersonal and communication skills: impactful oral and written communication.
NICE TO HAVE SKILLS
Preferred expertise in Polysaccharide production and Aseptic filling
Experience leading complex, multi-disciplinary troubleshooting efforts and data analysis
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