Contract Development and Manufacturing Specialist Specialist

Amgen Contract Development and Manufacturing Specialist

About Amgen

Amgen has been a Biotechnology Innovator since 1980, head quartered in Thousand Oaks in California. The Amgen site in Dún Laoghaire (ADL) has been open since 2011 and as such has continued to grow in the Amgen Network. At ADL we specialise in Formulation, Aseptic Drug Product Filling and Lyophilisation. Committed to serving our patients and continuing building a space where ideas from all perspectives can thrive.

Role Summary

Amgen is seeking a Specialist to join the External Process Development Organization. The ACDM, Contract Testing Laboratory (CTL) Specialist will work with CRO’s/CTLs’s to deliver on Amgen’s pipeline molecules. The CTL team in ACDM will develop the external sourcing strategy for Amgen’s commercial and development portfolio for external contract testing laboratory.  The CTL team is part of the External Supply organization is accountable for the execution of testing activities associated with the laboratory within scope.

Role Responsibilities include:

• Laboratory Supplier relationship management, including development and reporting of metrics and monitoring performance to continuously improve efficiency and effectiveness of suppliers.
• Building and maintaining strong partnerships with all external laboratory functions to increase overall effectiveness and success of programs. 
• Ability to operate in cross-functional teams
• Project management of a portfolio of cross-disciplinary external projects traversing the areas of Drug Product, Drug Substance, and Attribute Sciences.  Primary focus will be to manage delivery of analytical work packages (method qualification, method transfer, release testing, stability testing, characterization sample management) with external contract laboratories
• Actively participate in cross-functional teams with clear accountability for performance and ensure the quality, cost, and delivery of products from Amgen's Contract Testing Laboratory sites are consistently met, as well as lead issue resolution, problem solving and serve as an escalation agent.
• Responsible to ensure analytical escalations are captured and communicated accurately and timely
• Identification of project optimization opportunities (timeline, budget, technical execution), prioritization of a rolling portfolio of projects
• Ensure that designated ACDM lead programs meet compliance, speed, quality, and cost targets through strong scientific and technical understanding of the programs and drug product development.
• Identification of project optimization opportunities (timeline, budget, technical execution), prioritization of a rolling portfolio of projects
• Supplier evaluation and selection
• This position will require occasional domestic and international travel

Basic Qualifications

• Doctorate degree and 2 years of engineering, science or business management experience OR
• Master’s degree and 4 years of engineering, science or business management experience OR
• Bachelor’s degree and 6 years of engineering, science or business management experience OR
• Associate's degree and 10 years of engineering, science or business management experience OR
• Leaving Certificate and 12 years of engineering, science or business management experience

Preferred Qualifications

• Advanced degree in engineering or the sciences.
• Experience in large molecule analytical development including method development, method qualifications/transfers/validations, release, stability and characterization testing. 
• Self-starter with a high-level of comfort with ambiguity and complexity and the ability to multi-task while consistently delivering quality results
• Experience interfacing with domestic and international CTL /CRO organizations
• Strong understanding of cGMP, Regulatory/CMC, legal, Quality requirements and import/export policies
• Demonstrated understanding of drug development and commercialization for synthetic and/or biologic therapeutics
• Experience as team member/leader of cross-functional and matrixed teams including effective writing, presentation, organizational and interpersonal skills to address a broad scope of audiences
• Proven business acumen, high level strategic thinking, and strong analytical skills with the ability to structure, pragmatically scope, and solve complex problems
• Demonstrated quantitative skills including experience in business process development, continuous improvement, operational excellence and performance management

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

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Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.