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Job Title Senior Field Manager Product Transfer
In this role you will
With evolving GSK pipeline and new product transfers in emerging markets, GSK Vaccines global Technology Transfer department is looking for a Product Transfer Sr.
Field Manager expected to closely oversee and influence transfer operations at local receiving sites.
The Senio Field Manager Product Transfer is responsible to :
Act as point of contact for global Transfer team for end-to-end transfer activities, from design / engineering phases, utilities qualification and equipment readiness to process runs and validation
Closely oversee the overall process transfer activities at receiving site (routine operation, field, technical support, and validation) for primary and secondary process and ensure detailed plans are in place
Support and oversight of validation activities on the field : execution of validation (water run, engineering run, Process validation
Represent GSK transfer team at receiving site and provide recommendations on-the-field where applicable, by liaising with global technical experts (providing all technical information to the SPOC product transfer)
The support will cover the following expertise : media preparation, primary process (upstream and downstream processes) secondary processes (formulation, filling, visual inspection, CCIT, Packaging, aseptic processes) transversal support (HVAC, environmental monitoring, CIP, SIP, clean utilities, media simulations), utilities and equipment qualification and providing the risk assessment support
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following :
Participate in transfer governing bodies (PMCs and Steering Committees) and provide updates on the progress of transfer activities at receiving site and timely escalation of potential issues
To support the execution of the validation strategy and planning for all transversal validations (autoclave, Clean Utilities, CIP, SIP, etc.
by liaising between the global Transfer and the local teams
To oversee maintenance and requalification programs at receiving site
To oversee equipment qualification at receiving site for new equipment or for re-qualifications needed for the transfer
To oversee utilities qualification at receiving site, in case of revamps or new areas installed
To follow completion of engineering activities and escalate any issues / delays to the global Transfer team
To provide technical advice to the local team in case of issues, deviation and CAPA definition related to the technical field, as needed
To highlight potential risks to timely transfer execution and collaborate in the preparation of the mitigation strategy
To ensure and maintain oversight of a detailed plan of engineering, qualification and validation activities at receiving site
To oversee the availability of all documentation required to support the validation (URB, BD, FAT, SAT, IQ, OQ, VMP, PQ, VSR, Continuous Validation, risk assessment...) at receiving site
Liaise with local Engineering Services when support is requested from partner’s facility design for escalation to global Transfer team
Provide all technical / product information to technical partner according to the phasing defined in the project charter, focusing primarily on process but also on QC, QA, Engineering and Regulatory aspects
Extensive on-site presence at local receiving facilities is expected
Qualifications & Skills :
University degree in Chemical or Biotechnology Engineering preferred with minimum 8-10 years experience in managing engineering projects in Vaccines field, Life sciences, Pharma, Biotechnology
Preferred Qualifications & Skills :
Scientific and technological know-how related to vaccine manufacturing and secondary operations.
Expertise in vaccine products
Expertise in vaccine products
Flexibility to face rapidly changing environment and priorities
Ability to work in a matrix organization
Project management skills
Skills to report internally and externally
Social skills to foster teamwork of people belonging to different organizations / departments / sites.
Excellent communication and negotiation skills
Lean / Six Sigma capabilities and Orange / Green Belt certification will be an added value
Fluency in English is a must; Hindi mother tongue is preferred