Job Abstract

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Senior Engineer

What you will do

Let’s do this! Let’s change the world!

As part of Amgen’s Process Development organization, Drug Product Technologies (DPT) is seeking a highly motivated Senior Engineer to provide process development support to Amgen’s clinical and commercial sterile fill-finish manufacturing plant in Thousand Oaks, CA (ATO). The candidate will play a key role in bringing a wide variety of high-quality clinical and licensed drug products to patients through demonstrated excellence in aseptic processing, technology transfer, process characterization, process validation and continuous process verification. A focus on visual inspection compliance and network alignment on best practice is a significant expectation within this role, and an established track record in Continuous Improvement is of particular interest.

Visual Inspection Support / Leadership

• Influences and supports the establishment of robust tactical and strategic objectives related to visual inspection, with particular emphasis on the evolving state of regulatory expectations, and alignment within the Amgen network.

• Engages in the New Product Introduction and ongoing manufacturing spaces to direct the development and maintenance of Manual Visual Inspection methods for an expanding product portfolio.

• Leads a cross-functional effort directed at defect limit establishment and upkeep, following a scientific methodology based on data-driven analysis of ongoing and historical performance.

• Liaises with key collaborator partners in response to defect limit excursion, and owns investigations related to same.

• Represents the Building 20 Site PD organization at global network governance level, and is responsible for policy and practice alignment.

• Provides Process Development expertise for clinical and commercial drug product particle / defect identification and contributes to the maintenance of local and global particle / defect libraries. Actively participates in unknown defect characterization.

• Supports ongoing development in the area of Visual Inspection (i.e. introduction of AVI, development and maintenance of defect panels, establishment of GMP procedures related to operations).

• Establishes a comprehensive training program for the onboarding, development and progression of members within the visual inspection area.

• Leads / supports new product introductions (NPI) and lifecycle changes into the ATO DP manufacturing site by integrating the product’s process design and requirements with the site’s procedures and capabilities.

• Designs, implements and documents off-line and on-site DP characterization studies in support / ownership of technology transfer & PPQ.

• Supports make-a-batch exercises to determine facility fit and identify gaps.

• Author and/or own high-quality process technology transfer and other technical documents.

• Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.

• Ensure that the site meets the quality requirements of its customers and applicable laws (FDA, EU & global standards).

• Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations.

• Provide input to authoring of regulatory submissions / RtQ’s.

• Leads or assists in process related deviations, exception resolution and root cause analysis to ensure smooth operations & continued supply. Assists in solving issues with drug product processing technologies and equipment.

• Embodies the use of science-based methodologies to rigorously drive to true root cause, such that decisions are both timely, and supported by clear Claims / Reasons / Evidence-based reasoning, ensuring patient safety.

• Conducts risk assessment for drug product operations and propose / implement appropriate Corrective / Preventative Actions (CAPA) for continuous improvement.

• Serve as SME in new DP manufacturing technologies introduced into B20 and work with global multi-functional teams for shared best practices and technical advancements across Amgen clinical and commercial fill-finish plants.

• Work with a team of engineers and individually to design, execute and document primary data packages related to new technology development, while demonstrating specific expertise in aseptic processing and unit operations characterization.

• Supports expansion projects by supporting equipment user requirements, FAT, Process Characterization and Validation in all sterile fill finish processing areas.

• Establishes strong working relationships with partner sites across DP Manufacturing network to foster the sharing of technical best practices, improvement opportunities and lessons learnt to deliver high-quality manufacturing processes.

• Acts as single Point of Contact (POC) to drug product teams to provide expertise/knowledge of manufacturing site process capabilities and practices across an array of processing technologies, but principally visual inspection.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications (to be reviewed and revised by HR)

• Doctorate degree OR

• Master’s degree and 2 years of Engineering and/or Operations experience OR

• Bachelor's Degree and 4 years of Engineering and/or Operations experience OR

• Associate's degree and 8 years of Engineering and/or Operations experience OR

• High school diploma/GED and 10 years of Engineering and/or Operations experience

• Advanced degree in engineering, biotechnology, life sciences or related field

• 4+ years of experience in the pharmaceutical or biotechnology industry that includes elements of visual inspection, process development, process characterization, and technical transfers to manufacturing sites.

• Demonstrated expertise in leading functional area deliverables from planning through completion, with measurable impact to business outcomes. Ability to set, and achieve, tactical and strategic goals in a dynamic manufacturing environment, with due considerations for competing priorities.

• Experience in applying fundamental engineering and scientific principles to the characterization of freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection.

• Project management skills, including the ability to manage numerous projects and evaluate project resource requirements.

• Demonstrated ability in providing leadership to multi-functional teams to advance complex projects to completion and influencing decisions.

• Ability to lead innovation, collaborate in a multi-functional team environment, and act on dynamic information at a rapid pace

• Ability to independently design and execute characterization studies, author characterization protocols, process transfer documents, application notes and technical reports

• Proficiency in technical problem solving, critical thinking, and delivery of technical solutions with limited oversight

• Capable of organizing and communicating complex technical concepts to enable business decisions

• Strong knowledge of Quality systems and Drug Product Manufacturing (GMP).

• Demonstrated ability to use interpersonal skills to build strong technical relationships.

• Self-motivation, adaptability and a positive attitude.

• Excellent communication skills, both oral and written.

• Ability to elevate relevant issues to project lead and line-management.

• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and align with company policies.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

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.

Amgen offers a Total Rewards Plan comprising 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 including:

• 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 and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.

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Salary Range