Process Development Sr Associate

Amgen • New Albany, OH

2d

About The Position

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. 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. Sr Associate Laboratory Operations - Process Development What you will do Let’s do this. Let’s change the world. In this role, the Sr Associate Laboratory Operations is responsible for the validation of laboratory instruments/equipment and be able to provide hands-on training, execution, operation, and sustainment of Process Development (PD) laboratory operations at the Amgen Ohio Site. This role has specific accountability for the general PD laboratory spaces, challenge kits, and preliminary diagnostic capabilities that support manufacturing and development activities. Reporting to the Associate Director of Process Development, this role is a key individual contributor supporting site operations, issue resolution, inspection readiness, and the lifecycle management of validated and compliant laboratory instruments/equipment/systems. The Sr Associate Laboratory Operations provides support to Process Development while partnering closely with Manufacturing, Engineering, Quality, and other cross functional departments.

Requirements

• Master’s degree OR Bachelor’s degree and 2 years of experience GMP-regulated environment Or Associate’s degree and 6 years of experience GMP-regulated environment Or High school diploma / GED and 8 years of experience GMP-regulated environment

Nice To Haves

• Educational background in Engineering, Life Sciences, or a related technical discipline.
• Experience with commissioning, qualification, and validation (CQV) of facilities, utilities, equipment, and laboratory systems.
• Direct Hands-on experience supporting PD laboratories, laboratory equipment, or validation activities.
• Experience with advanced inspection, testing, or forensic diagnostic technologies. supporting manufacturing and development operations.
• Strong knowledge of cGMP regulations, data integrity, laboratory compliance, and validation lifecycle principles.
• Proven experience leading organizations through regulatory inspections.
• Demonstrated ability to influence across functions and organizational levels.
• Strong written and verbal communication skills.
• Experience driving Operational Excellence, business process improvement, and standardization initiatives.
• Ability to thrive in a fast-paced, highly regulated manufacturing and development environment.

Responsibilities

• Lead the validations of laboratory systems, equipment, method transfer, and are commissioned, qualified, and maintained in a validated state.
• Develop and execute validation strategies aligned with regulatory expectations, corporate standards, and site business objectives.
• Own or oversee validation governance, including validation plans, lifecycle approaches, and risk-based strategies for PD Laboratory.
• Establish and maintain periodic review and ongoing monitoring programs to ensure continued state of control for validated laboratory systems, equipment, and methods.
• Provide ownership of day-to-day operation, readiness, and compliant use of PD laboratory spaces and equipment, which include device testing equipment, diagnostic tools, and controlled laboratory spaces.
• Serve as primary technical owner for assigned PD laboratory systems and equipment
• Ensure PD laboratory equipment and diagnostic technologies (e.g., X-ray inspection systems, Keyence microscopes, and other forensic analysis tools) are qualified, maintained, and used in alignment with intended use and regulatory requirements.
• Lead and support preliminary assessments of manufacturing component and process issues, partnering with Manufacturing and PD to rapidly identify potential root causes and risk to product quality.
• Partner with PD and Engineering to support new lab build-outs, renovations, modifications, technology introductions, and advanced inspection capabilities.
• Establish and maintain laboratory compliance standards, including expectations for equipment use/inventory, maintenance, documentation, and data integrity.
• Ensure laboratory and validation practices align with cGMPs, global regulatory requirements, data integrity expectations, and internal policies.
• Serve as a primary laboratory and validation contact during regulatory inspections, internal audits, and corporate assessments.
• Lead or support forensic investigations related to manufacturing deviations, atypical results, and component or equipment-related failures, including the application of advanced inspection and diagnostic techniques.
• Ensure timely and compliant resolution of deviations, CAPAs, change controls, risk assessments, and laboratory investigations.
• Maintain inspection-ready documentation, systems, and processes at all times.
• Establish, implement, and maintain laboratory and validation standards, including standardized approaches for qualification, periodic review, and ongoing verification.
• Oversee the development, qualification, maintenance, and lifecycle management of challenge kits to support equipment qualification, method verification, and manufacturing readiness.
• Ensure challenge kits and test methods are scientifically sound, fit-for-purpose, and consistently applied across PD and manufacturing lines.
• Lead or support analytical and inspection method transfers to the site, ensuring successful deployment, training, qualification, and sustained compliant use.
• Ensure alignment with global and site standards while identifying opportunities to simplify, standardize, and improve compliance outcomes.
• Own and continuously improve laboratory and validation business processes, ensuring they are efficient, compliant, and scalable.
• Drive Operational Excellence (OE) initiatives across PD laboratory operations, validation, and compliance activities.
• Apply risk-based, lifecycle, and lean principles to improve execution efficiency while maintaining regulatory compliance.
• Monitor and trend key performance indicators (KPIs) related to validation execution, laboratory compliance health, periodic review status, and inspection readiness.
• Leverage data and metrics to identify trends, risks, and improvement opportunities.
• Partner with Manufacturing, PD, Engineering, Quality, Facilities & Utilities, and Regulatory to ensure aligned execution of projects and operational priorities.
• Provide validation, laboratory, and diagnostic capability input into capital projects, tech transfers, and process changes.
• Represent Validation and PD Laboratory Operations on site and network governance forums as required.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level