This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
The Specialist, Contract Development & Manufacturing at Amgen provides technical support to the External Supply manufacturing team, solves complex production problems, and implements improvements to enhance efficiency and quality. Working within a diverse Commercialisation & Performance Execution (CPE) team, this role works in partnership with different departments & stakeholders to ensure a smooth manufacturing process and compliance with quality standards. The role helps provide information insights and data analysis; identify problems and troubleshoot to evaluate options and solutions; drive precision through the execution of transactional/tactical tasks to ensure Amgen Contract & Development Manufacturing (ACDM) work cell (hub) success. The role also requires applying process, operational, and scientific expertise, as well as basic compliance knowledge and analytical and troubleshooting abilities, to support quality records originating from manufacturing sites throughout Amgen’s External Supply network. Additionally, the role provides a strategic dimension to the External Supply manufacturing network to improve operational competitiveness and ensure uninterrupted global supply of medicines to our patients – Every Patient, Every Time.
Job Responsibility:
Own Deviations (Major/Minor)
Liaise with Third Party CDMOs to maintain and monitor systems to ensure all deviations received are appropriately investigated and concluded per Amgen’s quality standards and procedures
Lead investigation teams to identify meaningful root causes and robust corrective and preventative actions by effectively utilizing advanced root cause analysis tools
Optimise deviation management, corrective and preventive actions effectiveness to prevent reoccurring events
Own SICAR | CAPA | CAPA EV | Change Control quality records
Liaise with Third Party CDMOs to maintain and monitor systems to ensure these quality records are appropriately managed and tracked to completion per Amgen’s quality standards and procedures
Report Third Party CDMO 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
Follow-up and track activities in a department-wide project (e.g., Technology Transfer) 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
Mentoring and leading of peers within own team and supporting the various functional areas in External Supply
Facilitation of cross-functional teams (internal and external to the site)
Work closely with the suppliers and External Supply peers to address and close critical investigations and Corrective Actions
Participate in the assessment or implementation of continuous improvement projects or initiatives
Requirements:
Bachelor’s in Business Administration, Engineering or Science-related field
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
Nice to have:
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
What we offer:
Competitive salary structure
generous Total Rewards Plan for staff and eligible dependents
comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, life and disability insurance
discretionary annual bonus program
exceptional learning, development and career advancement opportunities
hybrid work model
inclusive culture that values well-being, diversity, and work-life balance