12 Month Contract - Highly Remote
NOTE: The successful candidate is required to be located within Rep. of Ireland.
Sr Associate Contract Development & Manufacturing
The Sr Associate 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 the 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.
Responsibilities
Manufacturing Operations: The successful candidate is expected to own and execute
various quality record types, including Deviations (Major/Minor), CAPA, SICAR, Change
Control and perform metrics oversight responsibilities. Liaise with Third Party CDMOs to
maintain and monitor systems to ensure all record received are appropriately investigated
and concluded per Amgen's quality standards and procedures. Support/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.
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
Teamwork: Facilitation of cross-functional teams (internal and external to External Supply).
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. Communicate with all levels of the
organization, facilitate development of solutions to critical business issues, and effectively
define objectives to enable effective metric generation and reporting.
What we expect of you
The successful candidate for this role will bring the following education, skills and
experience.
Preferred Requirements:
Master's Degree (L9) in Business Administration, Engineering or Science-related field
Bachelor's Degree (L8) in Business Administration, Engineering or Science-related field,
with 2+ years of experience in GMP protein, API, DS, DP or packaging manufacturing
environment
Ordinary Bachelor's Degree or lower (L7 or lower) in Business Administration,
Engineering or Science-related field, with 5+ years of experience in GMP protein, API,
DS, DP or packaging manufacturing environment
Experience in roles requiring knowledge of cGMP principles, FDA and other regulatory
agency guidelines, and validation principles
Understanding of applicable manufacturing/testing processes (i.e. protein, API, Drug
Substance, Drug Product, Packaging, Device manufacturing processes)
Preferred Competencies:
Strong technical background with understanding of pharmaceutical manufacturing,
commercialisation, and cGMP knowledge / experience.
Problem-solving, critical thinking and decision-making skills.
Demonstrated negotiation skills, accountability to deliver results and meet deadlines
while handling contending priorities.
Technical writing and multi-level communication skills.
Demonstrated ability to perform effectively in a 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
Demonstrated experience with QMS and Digital tools including Veeva Vault,
TrackWise, AI software.
Experience with supporting/managing Third Party CDMO sites
