Associate Scientist - PKMD - Lab Operations

BioSpace; Thousand Oaks (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

Amgen is seeking an Associate Scientist PKMD Lab Operations in Thousand Oaks, CA. You will lead validation of laboratory software and GxP‑regulated equipment, ensuring compliance and data integrity while coordinating with cross‑functional teams.

Responsibilities include risk-based validation planning, documentation, and lifecycle management to keep systems inspection ready and validated. The role emphasizes collaboration, quality, and continuous improvement in a regulated environment.

Qualifications

• Masters degree and 1 year of laboratory experience.
• Bachelors degree and 3 years of laboratory experience.
• Experience with validated laboratory systems and GLP/GCP environments.

Responsibilities

• Lead validation activities for computerized systems and lab software.
• Develop risk-based validation strategies and plans.
• Coordinate qualification and validation testing activities.
• Maintain systems in a validated state throughout their lifecycle.

Skills

Validation leadership

Data integrity

Documentation

Cross-functional collaboration

Education

Masters + 1 year lab experience

Bachelors + 3 years lab experience

Tools

Laboratory instruments

Job description

Associate Scientist PKMD Lab Operations

Join Amgen’s Mission of Serving Patients.

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What You Will Do

In 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.

What We Expect Of You

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.

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, we will 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.

Application deadline

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

Sponsorship for this role is not guaranteed.

Equal Opportunity Employer

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.

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.