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LIVE, WIN, THRIVE

At Amgen, your ideas are the first step. We’re on a continued goal of transforming biotech to better understand human diseases and how to fight them. Here’s what it takes: The courage to dive into the challenges most won’t and never forgetting who relies on our success. With our combined perspectives, we can build a better world for patients. Join us and discover purpose through your career.

Role: Sr. Associate, Contract Development & Manufacturing – (12-month fixed term contract)

LIVE

What you will do

Reporting to the Director of Manufacturing Operations, Large Molecules, this position is responsible for support of manufacturing operations of Horizon Therapeutics’ s commercially marketed products at our CMOs.

This is a role for a professional who has a solid foundation of experience in a biotechnology manufacturing plant. It is a career development opportunity to gain further experience with a wide range of products and technologies as well as collaborating with a function such as Tech Development, Quality and Supply Chain.

Responsibilities:

• Work closely with Contract Manufacturing Organisations (CMO’s) to identify and assist and monitor improvements in manufacturing processes and operations

• Completes investigations and deviations in a timely manner to meet compliance standards

• Assesses and oversees implementation of process related change controls and Corrective Actions (CAPA’s)

• Interfaces regularly and builds strong working relationships with other departments, such as Technical Development, Quality Assurance, Quality Control, Supply Chain and Project Management

• Reviews Batch records, Standard Operating Procedures or other controlled documents as needed

• Gather and review CPV (Continuous Process Verfication) trend data as required

• Participates in continuous process monitoring to identify areas of focus for continuous improvement and process robustness

• Develop effective collaborative working relationships with counterparts within CMOs

Be part of our team

We are a team of agile, out-of-the-box thinkers who are inspired to do more because we know we are part of something bigger. Striving to build meaningful careers at a company whose values we share because when we live up to our potential, we help patients live up to theirs.

WIN

What we expect of you

To excel in this role, you should possess the following qualifications and skills:

• Batchelors or Master’s degree in Biochemistry, micobiology, biochemical engineering or related field

• 3+ years’ experience within manufacturing or technical operations in the pharmaceutical (biologics industry) with 3 years in a manufacturing drug substance process role

• Experience in investigations, using investigational tools and QMS systems

• Thorough understanding of good manufacturing/laboratory practices (GMP/GLP) and regulatory compliance/documentation requirements

• Proven track record in identifying improvement opportunities, engaging in cross-functional improvement efforts.

• International travel of up to about 2 weeks at a time will periodically be required when circumstances allow.

This role requires good judgment and strong initiative. You need to have the ability to effectively prioritise and manage a diversified workload, often to strict deadlines. You should have strong interpersonal skills, a professional approach with excellent written and verbal communication skills.

Our core values include Growth, Accountability, and Transparency. These core values and the competencies that support them are how we interact with one another and with the patients we serve.

In Horizon, we value and look to recruit people with these values and competencies.

THRIVE

What you can expect of us

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

• Vast opportunities to learn and move up and across our global organization

• 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

• Flexible working from home and remote options available for specific roles within Ireland

APPLY NOW

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

Equal Opportunity Statement

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

We will ensure that individuals with disabilities are provided a 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 an accommodation.