Responsibilities :
Lead complex technology transfers with a focus on right-first-time execution and risk management.
Perform as SME to identify technical areas for improvement, and supply chain improvement
Lead drug product Process Performance Qualification and preparation of regulatory reports. Support the internal and external teams to ensure manufacturing site readiness, reliability, and sustainability.
As needed, provide SME input on complex investigations, root cause identification, product impact assessment and corrective and preventive actions implementation.
Represent Pharmaceutical Innovative Medicine Supply Chain in interfacing with external manufacturing company.
Manages international sample shipments, execution of shipping route verification studies per SOPs, supports investigations and CAPAs as technical expert in the Drug Product manufacturing process.
Reviews and approves batch records, validation protocols, data, and reports.
Requirements :
Demonstrated technical competency and experience with biologic drug product.
Demonstrated experience in managing technology transfers and / or Life Cycle Management projects and investigations.
Partnering with R&D and JSC groups to improve the fit for plant and commercialization of new products into the supply chain.
Demonstrated leadership in providing integration of activities, information across multifunctional groups and sites.
Planning and logistics skills capable of effective integration of deliverables at the manufacturing site level.
Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams.
Ability to influence and lead peers, superiors, and external partners, including interaction with senior management.
Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly.
Ability to manage complexity and change.
Personal attitude and mindset.
Motivated, self-starter able to work independently with demonstrated problem solving skills.
Drives for innovation and change to ensure competitiveness.
Can-do mentality : takes initiative, creates a result-oriented working spirit in his / her team.
Engineer or Scientist, MSc or equivalent in a technical field (Chemistry, Pharmaceutics, Biological Sciences, Chemical Engineering) with +4 years of experience in biopharmaceuticals, or Bachelors + 8 years.
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