Sr Associate Contract Development and Manufacturing

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