HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Strategic Planning & Operations Manager

Amgen’s Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes innovative analytical tools to guide that development. Be part of Amgen's Attribute Sciences Business Operations team which supports compliance, safety, budget, lab operations, training, and resource management. As part of the Lab Operations team you will work closely with AS scientists, Information Systems (IS), and Quality Assurance (QA) to ensure the readiness of critical lab equipment.

Responsibilities Include

• Author/review/approve quality documents, such as: SOPs, user requirements, risk assessments, Data Integrity Assessments, Controlled Temperature Chamber documents, COTS validation protocols/reports.
• Provide various client areas with accurate and consistent requirements to help them make critical technical decisions
• Provide equipment and instrument support for Attribute Sciences staff, including Maximo administration (i.e. system ownership, etc.)
• Drives continuous improvement opportunities to increase compliance, alignment of equipment and instrument inventory, department’s standard methodologies and projects.
• Develops and maintains assessment and reporting tools to enable evaluation, communication, and issue of potential impacts / risks.
• Adheres to Current Good Documentation Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.
• Alerts senior leadership of quality, compliance and safety risks.
• Completes required assigned training to permit delivery of required tasks.
• Support ad-hoc special projects

Basic Qualifications

• Master’s degree OR Bachelor’s degree and 2 years of Scientific and/or Business Analysis and/or Quality Assurance experience OR
• Associate’s degree and 6 years of Scientific and/or Business Analysis and/or Quality Assurance experience OR
• High school diploma / GED and 8 years of Scientific and/or Business Analysis and/or Quality Assurance experience

Preferred Qualifications

• Experience in the biopharmaceutical or pharmaceutical industry, which includes understanding of cGMP requirements and current standards for analytical instrument qualification (USP <1058>, etc)
• Experience qualifying analytical instrumentation/computerized systems and software applications
• Excellent oral and written communication skills and excellent social skills
• Ability to prioritize tasks and work in a fast-paced work environment
• Experience in leading multiple, complicated priorities in a fast-paced environment
• Knowledge of software/equipment lifecycle and 21 CFR Part 11
• Familiarity with coordinated service providers and processes (i.e. JLL, ULS, PKI)
• Familiarity with environmental monitoring systems (ie. CEMS)
• Project management skills and experience
• Direct COTS Validation experience with pharmaceutical or biopharmaceutical processes

Thrive

Some of the vast rewards of working here

As we work to develop treatments that look after 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 improve your potential along your career journey
• A diverse and expansive 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 for a career that uses imagination

Objects in your future are closer than they appear. Join us.

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