Associate Scientist PKMD Lab Operations

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer heart disease inflammatory conditions rare diseases and obesity and obesity-related conditions. 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.

Associate Scientist PKMD Lab Operations

Lets do this. Lets change the this vital role you will be responsible for ensuring that laboratory equipment computerized systems and associated processes remain compliant fit for intended use and inspection-ready throughout their lifecycle. The role provides validation leadership and support for GxP-regulated systems and equipment including planning risk assessment change control testing documentation implementation maintenance and retirement activities.

This position partners with system owners laboratory scientists IT automation Quality Data Integrity and external vendors to maintain regulatory compliance and data integrity in alignment with 21 CFR Part 58 and Part 11 requirements. The Associate Scientist also supports equipment setup and assists scientific staff with compliant data generation quality control user access reporting and SOP adherence.

Key Responsibilities:

Computerized System Validation (CSV)

• Lead and support validation activities for computerized systems laboratory software and GxP-regulated applications.
• Develop validation strategies using risk-based validation principles.
• Author review and maintain validation deliverables including:
  • Validation Plans (VPR)
  • Risk Assessments
  • Requirements Specifications
  • Qualification Protocols
  • Traceability Matrices
  • Validation Summary Reports (VSR)

• Coordinate and execute qualification and validation testing activities.
• Ensure systems maintain a validated state throughout their lifecycle.

Change Control & Lifecycle Management

• Lead validation assessments for equipment and system changes.
• Evaluate software upgrades patches configuration changes and system enhancements.
• Participate in system implementation expansion relocation and decommissioning activities.
• Support periodic reviews and lifecycle documentation maintenance.

Compliance & Data Integrity

• Ensure compliance with applicable regulations including GxP requirements and electronic records controls.
• Support audit readiness and regulatory inspections.
• Review system security user access controls audit trail functionality and data integrity controls.
• Investigate and document validation exceptions deviations and corrective actions.

Cross-Functional Collaboration

• Partner with laboratory operations system owners SMEs IT automation quality and vendors.
• Facilitate validation kickoff meetings testing coordination and issue resolution.
• Provide validation guidance for new technologies laboratory instruments and business processes.
• Support business continuity and disaster recovery planning for regulated systems.

Documentation & Training

• Maintain complete and accurate validation documentation in approved quality systems.
• Develop and update validation procedures work instructions and templates.
• Train users and stakeholders in validation processes and change control requirements.
• Contribute to continuous improvement initiatives that enhance efficiency while maintaining compliance.

We are all different yet we all use our unique contributions to serve patients. The Associate Scientist we seek is a researcher with these qualifications.

Basic Qualifications:

Masters degree and 1 year of laboratory experience

OR

Bachelors degree and 3 years of laboratory experience

Preferred Qualifications:

• Advanced degree preferred.
• 5 years of experience supporting equipment quality laboratory operations information systems or regulated environments.
• Experience with computerized system validation and lifecycle management.
• Experience working in GLP GCP or other regulated environments.
• Experience supporting laboratory instruments data systems or automation platforms preferred.
• Strong understanding of validation methodologies.
• Knowledge of risk-based validation approaches.
• Familiarity with validation documentation traceability testing and change control.
• Understanding of data integrity principles and regulated system requirements.
• Excellent technical writing and documentation skills.
• Strong organizational communication and project coordination abilities.
• Ability to work effectively across multiple functions and priorities.

• Systems remain inspection ready and in a validated state.
• Validation deliverables are completed accurately and on schedule.
• Regulatory findings related to validation and data integrity are minimized.
• Effective support of system implementations upgrades and lifecycle activities.
• Strong stakeholder satisfaction and cross-functional collaboration.

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:

• A comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions group medical dental and vision coverage life and disability insurance and flexible spending accounts
• A discretionary annual bonus program or for field sales representatives a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship for this role is not guaranteed.

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.

Salary Range