Description
**Specialist Contract Development & Manufacturing**
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.
**NOTE:** The successful candidate is required to be located within Rep. of Ireland.
**Responsibilities:**
**Manufacturing Operations:** 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.
**Site Performance Monitoring:** 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.
**Project Management and Technology transfers:** 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.
**Teamwork:** 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.
**Win**
**What we expect of you**
The successful candidate for this role will bring the following education, skills and experience.
**Preferred 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
**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
**Thrive**
**What you can expect of us**
In addition to a competitive salary structure, Amgen offers a 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, empowering employees to grow and build long-term careers. At Amgen, we are committed to nurturing talent and providing meaningful pathways for professional development.
**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.
