上海招聘

Job Description :  GTO Principle Scientist 

Part A:  Overall Responsibility

To support activities related to technical manufacturing plant support & technical studies on technical / technology transfer projects, process improvement & productivity initiatives, material and process trouble shootings studies.  And ensure all supporting project are defined, planned, documented and executed in the compliance manner to Johnson & Johnson procedures, Regulatory requirement, GMP, EHS&S, Corporate quality standards and in accordance to J&J CREDO.

Part B:  Principal Responsibilities

1.              Embrace and practice the following Global Leadership Imperative

·       Integrity and CREDO-based actions

·       Connect (Collaboration and teamwork)

·       Shape (Innovation, Lead and adapt to change, Take and manage risk

·       Lead (Performance and development of self and others, Diversity)

·       Deliver (Empowering people, Global and enterprise – wide mindset, strategic thinking)

1. Global Technical Operation – Base Business Responsibilities

Key Role & Responsibility

• Technology Transfer (TT) project - Lead transfer of products from one manufacturing site to another manufacturing site within the AP network. The scope of work will include but no limited to: -
• Collect and review historical data of product stability/ process performance
• Coordinate the Development Plan/ GCC for TT formula with team members on their task deliverable to be included in the respective documents.
• Involving in formulation & raw material review and process design for manufacturing scale up mixing process. Perform laboratory batch study and manufacturing plant scale up trials.

·       To ensure all the mixing operation systems are updated accurately prior to scale up activities.

• To ensure all documents such as MWI, stability and bulk holding protocols are put in place and manage approval process as required.

·       Lead Technical assessment for formula bracketing and matrixing strategy for the mixing scale up activities

• Ensure local standard procedures and site specific specifications are up to date for validation or revised and manage approval process
• Execute product technology transfer project as per project timeline. Ensure completeness of documentation on timely basis.

·       Cost Improvement Projects (CIP) – To lead technical studies to support local or regional CIP initiative for productivity and / or cost improvement project and identify improvement opportunities to drive productivity and cost improvement which including raw material or process changes which are well defined and planned, documented and ensure execution in manner meeting GMP, health, Safety and Environmental and corporate quality standards.  The scope of CIP project will include but no limited to: -

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2. Manufacturing mixing process cycle time improvement
3. Productivity improvement
4. Eliminate non-value-added activities which drive cycle time improvement
5. Process improvement via technology innovation
6. Process Optimization  

• Plant Support (IM & EM) – to lead technical supports to internal and external manufacturing plant.  The scope of plant support will include but no limited to: -
• Provide ongoing general assistance in various miscellaneous plant activities
• Provide ongoing solutions to general challenges and issues that arise
• Site capacity increase qualification (tank qualifications,etc)
• Process qualification for secondary vessel to improve plant plannnig flexibility & agility.

• Manufacturing Process capability Improvements - identify critical process parameters, propose alternate process modifications.
• Product Complaint related to batch specific or site related.
• Support site alternate raw material phase in phase out event including site specific technical assessment
• Support mixing MWI specifications/ SAP BOM revision as required
• Product campaigning and sequencing study
• To coordinate accelerated stability program for formulation & process qualification if needed.
• To support Rapid Response event pertaining to plant capacity related and emergency site qualification
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·       Investigations and CAPA support  - to render technical support on trouble shooting, non-conformance investigation and root cause analysis pertaining to product formula, raw material and mixing process design.  The scope of INV/CAPA support will include but no limited to: -

• Extend techncial support to investigations related to product OOS or process deviation, and Consumer Complaints related to product only
• Conduct thorough root cause and historical data analysis, identify root cause and assess product impact
• Conduct laboratory experimentation as needed related to investigations and root cause analysis
• Write technical justification and other documentation including Product Impact Assessment, Technical Justifications and INV reports
• Ensure R&D lead CAPA related to process & formula design

3.         Documentation Control

·       Ensure all technical studies (qualifications, trial runs, lab batch studies etc.) are appropriately documented as per documentation system.

·       Ensure relevant technical specifications are maintained through change control procedure (GCC) & route for approval through Johnson & Johnson Global Spec system (TRU).

·       Ensure that specifications are maintained through change control procedure (GCC).

·       Ensure compliance to SOP requirements for specification and documentation.

·       To create bill of material (BOM) and maintaining BOM via SAP system for GTO lead project. Ensure mixed bulks BOMs in SAP system are accurately maintained.

·       To maintain in house GTO data base and formulation matrix in timely basis.

·       To revise the product relevant document through Johnson & Johnson Global Spec system (TRU).

5.         Self-Development

·       Identify improvement and seize learning opportunities, assimilate past lessons learnt and self-aspire to continuously challenge and improve status quo to sharpen technical as well as leadership skills.

·       Be participative and contributing team player in the organization.

·       Be responsible in self-development plan via proactive scheduling with 5-Conversation in timely basis. 

6.         GMP and EHS&S (Environmental, Health, Safety and Sustainability)

·       Ensure daily work practices adhere to GMP and HSE requirement

·       Ensure work station is clean and in order

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