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
5+ years of experience in protein, API, DS, DP or packaging manufacturing environment
5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
2+ years of project management experience leading multi-functional and/or multi-location team
1+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products
Preferred Competencies
Demonstrated matrix management and influencing skills.
Strong organisational and cross-functional project management skills.
Strong technical background with understanding of pharmaceutical manufacturing, commercialisation, and cGMP knowledge / experience.
Demonstrated negotiation skills, accountability to deliver results and meet deadlines while handling contending priorities
Strong project management skills.
Operational Excellence proficiency and ability to drive continuous improvement.
Financial/budgeting knowledge and business acumen.
Problem-solving and critical thinking and decision-making skills.
Understanding of contractual requirements.
Technical writing and multi-level communication skills.
Demonstrated ability to lead effectively in collaborative/team environment.
Demonstrated ability to take initiative, drive action, and work under minimum supervision.
Proficiency in Microsoft Office especially Project, Excel, PowerPoint, Visio, and Smartsheet
Why Join Amgen
Be part of a global biotechnology leader known for scientific innovation and patient impact.
Collaborate with international teams and gain exposure to world-class manufacturing and technology practices.
Work in a growth-focused environment with access to professional development programs and cross-functional learning.
Hybrid work model and inclusive culture that values well-being, diversity, and work-life balance.
NOTE: The successful candidate is required to locate close to Hyderabad, India.
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