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Sr Associate Contract Development & Mfg
Amgen
Hyderabad, IND
Full-time
Senior · 9+ years experience
Discovered 2 weeks ago
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Responsibilities:
- Project Management and Technology transfers: The role involves leading and managing new product introductions (NPI) and technology transfers to external (third party) manufacturing organizations. This includes coordinating cross-functional teams, ensuring adherence to business processes, and overseeing multiple complex projects. Responsibilities also cover project planning, budgeting, communication, and reporting, as well as driving continuous improvement initiatives to enhance quality, efficiency, and alignment with company priorities.
- Follow-up and track activities in a department-wide project from conception to implementation and close-out. Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to the right level.
- Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; contract inputs and requirements, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.
- Own Deviations (Major/Minor). Maintain and monitor systems to ensure all deviations received are appropriately investigated and concluded per the company's quality standards and procedures. Optimize deviations management, corrective and preventive actions effectiveness to prevent reoccurring events.
- Own SICAR | CAPA | CAPA EV and more complex change control records.
- Site performance monitoring: Report contract site performance metrics to site lead; identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardisation of performance tools used by the Work Centre Teams (WCT), oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team.
Qualifications:
- Preferred Requirements:
- Bachelor’s in Business Administration, Engineering or Science-related field with 5 to 9 years of experience
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