Specialist Quality Control Support - Empower

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities but it will also integrate sustainability innovations to reduce carbon and waste as part of Amgens plan to be a carbon-neutral company by 2027.

Specialist Quality Control Support - Empower

What you will do

Lets do this. Lets change the this pivotal role you will support ANC Quality Control as the sites Business Process Owner (BPO) for Empower. Reporting directly to the Manager of Quality Control Support you will serve as a subject matter expert for QC Empower based systems. Your expertise will help drive the startup validation and ongoing success of the QC Chemistry team utilizing the Empower based systems and enable manufacturing excellence. Because this role is tightly integrated with manufacturing operations occasional extended hours shift work or weekend support for troubleshooting may be required.

Working under minimal supervision the successful candidate will contribute to both startup and daily operations of the QC organization by:

System Leadership

• Leading QC Chemistry activities including Empower 3 FR5 qualification validation and upgrades.
• Managing the Empower BPO function including troubleshooting training and participation in cross-functional meetings.

Technical Expertise

• Supporting validation documentation for UPLC HPLC and CE computerized systems.
• Developing and executing Empower-based method transfer plans.
• Authoring reviewing and revising a wide range of documents: SOPs test methods safety assessments trend reports qualification/validation summaries technical reports and method/technical assessments.

Operational Support

• Owning and managing Deviation or CAPA records to maintain compliance and quality standards.

Continuous Improvement & Compliance

• Participating in audits initiatives and cross-functional or global projects.
• Driving process efficiency and ensuring alignment with quality and regulatory expectations.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The vital professional we seek is an effective leader with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Quality Analytical testing experience OR
• Associates degree and 8 years of Quality Analytical testing experience OR
• Bachelors degree and 4 years of Quality Analytical testing experience OR
• Masters degree and 2 years of Quality Analytical testing experience OR
• Doctorate degree

Preferred Qualifications:

• Experience working in a GMP Quality Control Chemistry Laboratory.
• Degree in Scientific Field such as Chemistry or Pharmaceutical Sciences or related scientific field.
• 4 years of relevant laboratory experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred.
• Experience with Chemistry Quality Control testing including but not limited to: HPLC UPLC Concentration and USP-NF methods.
• Strong Leadership Collaboration and Communication skills.
• Strong knowledge of laboratory techniques.
• Proficient in the use of Empower method templates and sample sets in Empower.
• Knowledge of related regulatory/industry considerations compliance issues templating and/or scientific discovery.
• Strong written and verbal communication skills including technical writing and presentation.
• Experience with equipment and method validation verification and transfer including the change control process.
• Interact effectively with variety of communication and working styles and ability to work well in teams.

What you can expect of us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

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.

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