Process Development Sr Associate

Career Category

Job Description

Join Amgens Mission of Serving Patients

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. 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.

Sr Associate Laboratory Operations - Process Development

What you will do

Lets do this. Lets 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.

Key Responsibilities

Validation Leadership & Strategy

• 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.

PD Laboratory Operations & Execution

• 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.

Compliance Forensic Investigations & Inspection Readiness

• 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.

Standards Challenge Kits & Governance

• 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.

Business Processes & Operational Excellence (OE)

• 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.

Cross-Functional Collaboration

• 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.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The associate we seek will possess these qualifications.

Basic Qualifications:

Masters degree

OR

Bachelors degree and 2 years of experience GMP-regulated environment

Or

Associates degree and 6 years of experience GMP-regulated environment

Or

High school diploma / GED and 8 years of experience GMP-regulated environment

Preferred Qualifications:

• 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.

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 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.

Apply now and make a lasting impact with the Amgen team.

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.

Application deadline

Amgen anticipates accepting applications until 2/11/26; however we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.

Sponsorship

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