Senior Engineer - Amgen

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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

Lets do this. Lets change the world. In this vital role you will play a key role in bringing a wide variety of high-quality clinical and licensed drug products to patients through demonstrated excellence in technology transfer, critical thinking, problem solving and process improvements. As the technology transfer lead, the Senior Engineer must successfully integrate the knowledge and information generated by cross functional teams with Amgens platforms, as well as clinical and commercial facilities capabilities to ensure success through the commercialization lifecycle.

• Support technology transfers of clinical and commercial products into Amgens drug product manufacturing facility in Thousand Oaks for a variety of parenteral modalities:
• Conduct and lead make-a-batch exercises to determine facility fit and identify gaps
• Design and execute offline and on-site drug product characterization studies
• Provide manufacturing on-site support as needed
• Evaluate product impact due to manufacturing process, production scale, equipment, and raw material changes
• Author and own high-quality process technology transfer and other technical documents
• Participate in authoring and reviewing relevant sections of regulatory submissions to enable successful introduction of new processes and/or production facilities across the parenteral portfolio
• Point of contact for early to late-stage drug product teams during process design by bringing awareness of tech transfer business process, manufacturing site capabilities, and collaborating with teams to address technical challenges.
• Work directly with clinical and commercial manufacturing in support of ongoing production, new product introductions, new technology introduction, and process optimization.
• Apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering (equipment, automation, chemical, mechanical) principles to support process scale-up.
• Support continuous improvements in the drug product development process through technological innovation and application of first principles in process engineering.
• Deliver progress reports and presentations (including generation and upkeep of dashboard) to engage with and ensure that management is aware of the current status and progress.

• 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.
• Provides expertise/knowledge of manufacturing site process capabilities and practices in drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization and visual inspection.

What we expect of you

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

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

Associates degree and 8 years of Engineering and/or Operations experience

Bachelors degree and 4 years of Engineering and/or Operations experience

Masters degree and 2 years of Engineering and/or Operations experience

Doctorate degree

• Advanced degree in engineering, biotechnology, life sciences or related field.
• 4+ years of experience in the pharmaceutical or biotechnology industry that includes elements of process development, process characterization, and technical transfers to manufacturing sites.
• Technology transfer experience across different development phases, fill-finish process scale-up, and the use of gap analysis, root cause analysis, and risk assessment tools.
• 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 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.
• Ability to lead innovation, collaborate in a cross-functional team environment, and act on dynamic information at a rapid pace.
• 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.
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
• Experience with conducting statistical evaluations of data to assess statistical significance, potential correlations, and process capability.
• Experience with clinical and marketing application regulatory filings.

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.

careers.amgen.com

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.

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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