Site Name: Singapore - Tuas
Posted Date: Apr 1 2023
MSAT department is focused on the potential of science to address the unmet needs of patients. We commits to those areas where we think we can really change the course of medicine and bring big new ideas to life. MSAT Product Stewardship team manages the entire lifecycle of products manufactured at GSK Tuas from inception, through engineering design and manufacture, to service and disposal of manufactured products. Product Steward and Product Expert oversight and ownership of all changes related to product (i.e. process change, raw material change that has potential impact to product & process) with the end to end view from incoming materials to finished product. MSAT Product Stewardship team implements and maintains the control strategy for drug substance production and introduces lifecycle changes (manages eCC for process parameters, process materials etc). MSAT Product Stewardship team drives process lifecycle management for next generation and continuous improvement of biologics drug substance manufacturing. They provide technical oversight of our commercial products and processes with an end to end view and throughout their lifecycle. They monitor process performance and product quality with CPV cycle. Holistic view of how the following inputs from other pillars of MSAT department has a cumulative impact on the process during PQR review such as (1) deviations & CAPAs, new validation/requirements from MSAT Manufacturing Support, (2) new understanding of the process from MSAT Process Science & Manufacturing Technology that leads to update of CPP, TRA & PCS, (3) new equipment, raw material, process parameters from MSAT Technology Transfer that could impact the process performance. MSAT Product Stewardship team provides technical assistance to commercial manufacturing team, including change assessment, process monitoring, troubleshooting and continuous improvement. Product Expert plays a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients\xe2\x80\x99 lives. One meaningful and holistic approach to today\xe2\x80\x99s current challenges within the pharmaceutical industry is to focus on Product Lifecycle Management (PLM), which is a business transformation approach to manage products and related information across the enterprise. In recent years PLM has provided many pharmaceutical organizations with the ability to increase their ability to get products to market quicker, ensure greater regulatory compliance and efficiencies while reducing development costs. The primary focus of the MSAT Product Expert role is to manage the entire lifecycle of products and processes manufactured at GSK Tuas from inception, through engineering design and manufacture, to service and disposal of manufactured products. The role of site MSAT Product Expert is the care keeping and continuous improvement of the body of technical knowledge that the site has. It includes how we manufacture our products and transmitting that product & process knowledge into manufacturing instructions. MSAT Product Expert reports to MSAT Product Stewardship Manager.

Key Responsibilities Area

Continued Process Verification :

• Participate to the CPV cycle of the designated product.
• Assist the Product Steward to manage CPV / QRB meetings
• Apply KPIs to enable meaningful CPP/CQA trending and reporting of key process data as well as to quickly identify changing quality trends and issues.
• Review and analysis process trending, identify changing quality trends and issues.
• With the support of Product Steward, suggest corrective actions to solve issue and improve the robustness and consistency of the manufacturing process. o Responsible of the initiation and maintenance of TRA, PCS, DTP, CQA and QTTP of the designated product.
• Compile, interpret, and organize process and product data for periodic reviews, as well as audits / regulatory support.
• Closely interact with the MSAT Manufacturing Support Engineers and VS to monitor process performance through real-time performance data.
• Collect, record, and product report metrics.
• Establish visual tracking and other tools to enhance Audit readiness and trend analysis.
• Read and interpret statistical diagrams, drawings, and other schematics. Monitor processes for performance and problem indicators.
• Update and manage the lifecycle of the process History file of the product.
• Aide users in both the Discoverant and PKM systems. Provide training as needed for both systems.
• Assess impact of changes on current validated process status and identify need for revalidation/revaluation activities.
• Provide product expertise for the commercial production (i.e. expertise in the management of critical deviation).
• Provide expertise in the periodic quality review.
• Remain relevant in new business intelligent tools and become a SME in the field.
• Provide product expertise for the commercial production (i.e. expertise in the management of critical deviation).
• Work closely with MSAT Manufacturing Support and MSAT Process Science & Manufacturing Technology teams to identify and confirm critical process parameters needed for equipment and process validation.

Audit Preparation & Project Management :

• Participate in L2 audit, corporate and regulatory inspections and front the inspector\xe2\x80\x99s questions as Subject Matter Expert.
• Lead projects related to product life cycle changes or optimisation.
• Lead product investigation task forces or working groups.
• Represent MSAT department or site during technical transfer activities as required

Product Lifecycle Management :

• Manage the entire lifecycle of products and processes manufactured at GSK Tuas from inception, through engineering design and manufacture, to service and disposal of manufactured products.
• Own and promote robust end-to-end product stewardship, ensuring single point of contact for products within the site and across sites for multi-site products.
• Manage end-to end process and product changes from design of the change control strategy, redaction, execution of PPQ protocol and reports to the submission of the changes. Provide justification/verification projects generate sufficient process knowledge by thoroughly testing critical variables.
• Review and release regulatory proposals or product information required for regulatory filings.
• Support and where appropriate lead optimisation of pharmaceutical processes by applying sound scientific reasoning (first principles) and following integrated process and technology strategies.
• Develop a deep product knowledge to become a recognized product expert for the site.
• Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area.
• Committed to knowledge sharing/transfer inside sites, other MPUs as well TRD.
• Write, review, and revise SOPs (Standard Operating Procedures).
• Report Product Impact assessment in process deviations when they occur.
• Coordinate/lead product task forces with representatives from other departments.
• Ensure the robustness of manufacturing processes so that all site products are validated and remain in constant state of validation throughout the product lifecycle.
• Maintain up to date consolidated PLM (Product Lifecycle Management) plans.
• Own and actively manage the Product Improvement Portfolio (PIP) allowing for prioritization and ensuring cross-functional contribution, as necessary.
• Analyse all assigned areas of operations for potential improvement opportunities and makes applicable recommendations for process, system, procedure, and operational changes to improve operations and quality.
• Apply appropriate change management methods to promote implementation of technology changes. Facilitate organizational change by helping to prepare personnel to accept and actively participate in new changes, through communication, coaching, and educational workshops.

Environment, Health, Safety and Wellness :

• Support, promote and participate in site\xe2\x80\x99s safety and wellness initiatives. Be a role model when appointed as a EHS Committee member, advocate and display safe behaviour and mindset at all time.
• Contribute and support EHS training activities aligned with Site vision and goals. Use PPEs correctly while working and follow the safety training and safety instructions and health rules and regulations.
• Contribute to the establishment of an active workplace safety. Be continuously on the lookout for anything that could lead to an accident. Be aware of the behaviour of colleagues too.
• Make daily safety inspections, provide input and feedback. about safety problems and solutions.
• Report all near miss accidents, dangerous occurrences or unsafe situations.
• Participate in enforcement inspections.
• Comply with all applicable safety standards.

Skills, Knowledge & Experience

• Scientist or Engineer with relevant experience in polysaccharide based Vaccines processes.
• University degree in Engineering and/or Science.
• Advanced science degree in data analytics or similar field is an asset.
• 5 - 8 years\xe2\x80\x99 experience cGMP-related commercial / clinical manufacturing / R&D experience
• Understanding of databases and SQL
• Strong MS Office background (Excel, Word, Project, PowerPoint, Visio, etc.)
• Have strong trouble shooting capabilities. Be able to use engineering thinking and principles to tackle complex technical/process issues.
• Have excellent written and verbal communication skills.
• Quantitative & qualitative analytical skills.
• Strong project management, planning, organizational and communication skills desired.
• Strong understanding of Life Cycle Management disciplines, cross functional skills and processes.
• Experience with process monitoring and statistical analysis of data using statistical software (such as RedStar, Spotfire, JMP, MiniTab, Discoverant, etc.)
• Proven project management experience : major projects with high level of complexity.
• Proven experience with complex, multiworkstream project management.
• Feel comfortable working in various cross functional teams.

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