Amgen · 9 hours ago
Process Development Sr Associate
US - Ohio - New Albany
Full-time
Onsite
Mid, Senior Level
$75K/yr - $102K/yr
2+ years expAmgen is a leading biotechnology company dedicated to serving patients with serious illnesses. The Process Development Sr Associate will be responsible for validating laboratory instruments and ensuring compliance with regulatory standards while supporting site operations and cross-functional collaboration.
BiotechnologyHealth CareManufacturingPharmaceutical
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
Qualification
Required
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
Preferred
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
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.
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
Recent News
2026-02-05
BioWorld Financial Watch
2026-02-05
Genetic Engineering News
2026-02-05
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