390824BR
Feb 18, 2024
China
About the Role
Location: Haiyan, Zhejiang
About the role:
The purpose of the job is to lead and execute the technical activities related to site according to project timeline without delays in the execution. The person must ensure process, technology and product is transferred to the site and will act as the go-to person for MS&T related activities withing the project and during transfer and implementation. Responsible for technology transfer activities at site level (within, inbound and outbound), including any scale-up or other process adaptations. Leads technical transfer project team at site and liaises efficiently with involved functions (e.g. Technical Development, Supply Chain, Production Unit, Quality Control, HSE, other sites.)
Key Responsibilities：
Stewardship – for transfer assigned
• Manage change control for process transfers and process adaptations and modifications
• Prepare regulatory submission, generation and review of source documents and CMC sections of the dossier
• Drafting and approval of SOPs and WI related to process, in alignment with Operations and Quality
• Process design: approval of aseptic processing steps within manual/semi-automated process, including media fills, smoke studies, etc.
• Review and update Quality Risk Assessment (QRA) prior to transfer and prior to validation, adapt control strategy if needed.
• Review first APQR after transfer to ensure adequate product performance.
• Counterpart with development for implementation of new processes, batch size increase, new components implementation, etc.
Validation – for transfer assigned
• Ensure that all relevant technical information and documentation for validation is available.
• Define pre-validation / validation strategy incl. process, cleaning, packaging and supportive studies (e.g., hold times). Coordinate technical, regulatory and validation batches at site.
• Support Validation Lead / Validation Expert in creation of validation protocol and report.
• Review validation protocol and report.
• Initiate monitoring and Ongoing Process Verification phase.
• Input, review and approval of equipment URS, changes, design documents, risk assessments (e.g. SRA and FRA), change controls, deviations and design reviews
• Prepare, review and approve commissioning, qualification and validation master plans
• Review, approval and execution of FAT/SAT, validation documentation including cleaning validation, shipment validation, process validation, technical transfer, filter validation, leachable and extractable, mixing validation, VHP, smoke tests and any other validation activity
• Documentation preparation, review and approval for qualification and validation
• Input on layout, pressure cascades, environmental monitoring strategy and parameters, contamination control strategy based on process and product knowledge
• Assessment of equipment and line set-up for manufacturing
Launch & Transfer
• Act as SPOC on site for technical transfer.
• Perform technical feasibility assessment for supply point decision in close collaboration with other stakeholders. Determine scope / design of technical batches for transfer.
• Provide input into overall project strategy and plans including timelines.
• Initiate local change control in system on site and ensure approval and closure.
• Establish site project plan, elaborate scientifically sound technical strategies with project team, develop contingency plans, identify hurdles and propose solutions. Assess and plan site resource needs and get management approval for the overall project costs (e.g. FTEs, batch costs, investments and external costs), strategies, and timelines.
• Form and lead site project team - set priorities for project and project team meetings, coordinate project team activities, ensure that Novartis guidelines and HSE and GMP guidelines are met.
• Ensure that project tracking documentation/tools are up-dated according to plan.
• Ensure timely availability of technical documentation according to Novartis guidelines. Write Manufacturing Process Transfer Documents (protocol, report).
• Review key documents and coordinate input for relevant registration documents for accuracy and completeness (as appropriate).
• Liaise with global project manager, giving site (CMC team for development transfers) and site functions. Ensure knowledge transfer from giving site to receiving site including to operators.
• Contribute to inspection (Pre Approval Inspection PAI) readiness.
• Ensure site readiness for technology acceptance and campaign start-up.
• Establishes local procedures & templates for technical transfer.
• Knowledge transfer to operations
• Planning of PQ and validation activities
• Project management collaboration to ensure equipment readiness for process validation
• Project execution and commercial readiness according to plan
Manufacturing Excellence – for transfer assigned
• Contribute to process improvement and optimization for product transfers.
Training
• Own the Training Curriculum for own Job Profile and direct reports.
Novartis Manufacturing Manual
• Support implementation of Novartis Manufacturing Manual principle 3.
About the role:
The purpose of the job is to lead and execute the technical activities related to site according to project timeline without delays in the execution. The person must ensure process, technology and product is transferred to the site and will act as the go-to person for MS&T related activities withing the project and during transfer and implementation. Responsible for technology transfer activities at site level (within, inbound and outbound), including any scale-up or other process adaptations. Leads technical transfer project team at site and liaises efficiently with involved functions (e.g. Technical Development, Supply Chain, Production Unit, Quality Control, HSE, other sites.)
Key Responsibilities：
Stewardship – for transfer assigned
• Manage change control for process transfers and process adaptations and modifications
• Prepare regulatory submission, generation and review of source documents and CMC sections of the dossier
• Drafting and approval of SOPs and WI related to process, in alignment with Operations and Quality
• Process design: approval of aseptic processing steps within manual/semi-automated process, including media fills, smoke studies, etc.
• Review and update Quality Risk Assessment (QRA) prior to transfer and prior to validation, adapt control strategy if needed.
• Review first APQR after transfer to ensure adequate product performance.
• Counterpart with development for implementation of new processes, batch size increase, new components implementation, etc.
Validation – for transfer assigned
• Ensure that all relevant technical information and documentation for validation is available.
• Define pre-validation / validation strategy incl. process, cleaning, packaging and supportive studies (e.g., hold times). Coordinate technical, regulatory and validation batches at site.
• Support Validation Lead / Validation Expert in creation of validation protocol and report.
• Review validation protocol and report.
• Initiate monitoring and Ongoing Process Verification phase.
• Input, review and approval of equipment URS, changes, design documents, risk assessments (e.g. SRA and FRA), change controls, deviations and design reviews
• Prepare, review and approve commissioning, qualification and validation master plans
• Review, approval and execution of FAT/SAT, validation documentation including cleaning validation, shipment validation, process validation, technical transfer, filter validation, leachable and extractable, mixing validation, VHP, smoke tests and any other validation activity
• Documentation preparation, review and approval for qualification and validation
• Input on layout, pressure cascades, environmental monitoring strategy and parameters, contamination control strategy based on process and product knowledge
• Assessment of equipment and line set-up for manufacturing
Launch & Transfer
• Act as SPOC on site for technical transfer.
• Perform technical feasibility assessment for supply point decision in close collaboration with other stakeholders. Determine scope / design of technical batches for transfer.
• Provide input into overall project strategy and plans including timelines.
• Initiate local change control in system on site and ensure approval and closure.
• Establish site project plan, elaborate scientifically sound technical strategies with project team, develop contingency plans, identify hurdles and propose solutions. Assess and plan site resource needs and get management approval for the overall project costs (e.g. FTEs, batch costs, investments and external costs), strategies, and timelines.
• Form and lead site project team - set priorities for project and project team meetings, coordinate project team activities, ensure that Novartis guidelines and HSE and GMP guidelines are met.
• Ensure that project tracking documentation/tools are up-dated according to plan.
• Ensure timely availability of technical documentation according to Novartis guidelines. Write Manufacturing Process Transfer Documents (protocol, report).
• Review key documents and coordinate input for relevant registration documents for accuracy and completeness (as appropriate).
• Liaise with global project manager, giving site (CMC team for development transfers) and site functions. Ensure knowledge transfer from giving site to receiving site including to operators.
• Contribute to inspection (Pre Approval Inspection PAI) readiness.
• Ensure site readiness for technology acceptance and campaign start-up.
• Establishes local procedures & templates for technical transfer.
• Knowledge transfer to operations
• Planning of PQ and validation activities
• Project management collaboration to ensure equipment readiness for process validation
• Project execution and commercial readiness according to plan
Manufacturing Excellence – for transfer assigned
• Contribute to process improvement and optimization for product transfers.
Training
• Own the Training Curriculum for own Job Profile and direct reports.
Novartis Manufacturing Manual
• Support implementation of Novartis Manufacturing Manual principle 3.
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
Essential Requirements:
• BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree. Desirable MSc. or equivalent experience
• 8 years of relevant experience in pharmaceutical manufacturing; comprehensive know how in pharmaceutical technology, project management experience
• Fluent in English and proficient in Mandarin
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Accessibility and Accommodation:
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.
• BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree. Desirable MSc. or equivalent experience
• 8 years of relevant experience in pharmaceutical manufacturing; comprehensive know how in pharmaceutical technology, project management experience
• Fluent in English and proficient in Mandarin
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Accessibility and Accommodation:
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Operations
SMALL MOLECULES
China
Jiaxing
Novartis Pharma Beijing
Technical Operations
Full Time
Regular
No
