Associate Director of Engineering - Synthetic & Hybrid DS

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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.

Associate Director of Engineering - Synthetic & Hybrid DS

What you will do

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

Would you like to work with a highly motivated team of process development experts and professionals to positively impact patients’ lives?

Amgen is seeking an Associate Director of Engineering in the Drug Substance Technologies – Synthetics (DSTS) organization within process development. In this role, the Associate Director is accountable to drive technical and strategic solutions for the development, characterization, and technology transfer of synthetic and hybrid drug substance manufacturing processes across all phases of clinical development, commercial advancement, and lifecycle management.

This position is on-site and located in Thousand Oaks, CA.

Domestic and International Travel: up to 20%

Core Responsibilities:

• Contributes to and leads program deliverables for the advancement of our synthetic & hybrid portfolio through all stages of development and commercial advancement

• Accountable for establishing and implementing engineering standards for commercial process development and process characterization

• Drives excellence in execution for technical transfers of innovative DS processes

• Adheres to and drives all standards for safety, quality, and compliance

• Maximizes performance through the continuous growth of technical and strategic competencies within the engineering team

Scientific and technical eminence:

• Technical and strategic leadership of our drug substance processes utilizing a foundational chemical engineering skillset and practical knowledge of relevant unit operations.

• Process Development: supporting the development of chemical processes and positioning drug substance processes for commercialization success by designing and executing experimental plans; leading, executing and deploying process-analytical tools (PAT) to enable process understanding and design; process simulation using an array of process modeling and engineering tools; and process characterization.

• Expert Analysis: including process and technology review analysis and improvement identification; assessment of applicable new technologies and techniques.

• Contribute to increasing the effectiveness and efficiency of the department by contributing towards improvements of guidelines, procedures, practices, standards and cross-functional business interfaces and processes.

Teamwork and leadership attributes:

• Contributes effectively as an individual and routinely leads process engineering and drug substance development teams

• Builds and nurtures relationships with cross-functional partners to drive strategic initiatives and program objectives

• Identifies resource needs and establishes priority for projected activities

• Facilitates cohesiveness and builds team spirit as we work toward a common goal to develop industry-leading medicines that serve patients

• Communicates effectively with others, leveraging compassion and the principles of people-centered leadership

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 a leader with these qualifications.

Basic Qualifications:

• High school diploma / GED and 14 years of Operations experience OR

• Associate’s degree and 12 years of Operations experience OR

• Bachelor’s degree and 9 years of Operations experience OR

• Master’s degree and 7 years of Operations experience OR

• Doctorate degree and 3 years of Operations experience

• In addition to meeting at least one of the above requirements, you must have a minimum of 3 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications:

• 8+ years of relevant chemical engineering experience driving individual and group deliverables related to synthetic process development and chemical manufacturing in pharmaceutical development.

• Experience in developing and executing experimental plans to evaluate and develop processes to achieve optimum cost, robustness, safety, sustainability, and productivity.

• Experience related to technology transfer, scale-up and manufacturing of synthetic molecules and hybrid modalities in a regulated environment. This includes technical support for non-conformance investigations and other commercial support activities.

• Experience building and utilizing first-principle models (e.g., reaction kinetics, mass transfer, separations, distillations, isolations, drying, and hydrodynamics) with proficiency across several modeling platforms.

• Fluency in lab-based execution of and data interpretation for wide variety of analytical methods, process analytical tools, and solid-state characterization methods including HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size determination, etc.

• Evaluate early- and late-stage chemical processes to establish and execute lab-based pre-requisites to enable of bench/kilo laboratory experiments to ensure successful scale-up to manufacturing scales.

• Apply chemical engineering fundamentals and procedures to provide solutions to a variety of technical chemical and process issues that will be encountered during process development, tech transfer and scale-up, including leading on the floor support and rapid problem solving and decision making.

• Apply engineering principles and statistical analysis, including design of experiments, evaluate chemical processes for potential process improvements to enable successful scale-up and transfer to manufacturing sites.

• Lead and manage authoring of technical documentation required for process characterization design plans, failure-mode risk assessments for science-based determination of parameter and test criticality, engineering scale-up evaluations, process validation preparedness across all stages of development.

• Experience authoring regulatory documents for commercialization of drug substance processes: CMC Module 3, RTQs, and annual reports.

• Practical experience using data science and/or advanced statistical analysis to solve processing issues and evaluate opportunities for process improvements.

• Proficient understanding of regulatory and cGMP requirements

• Command of lab and plant operations and associated safety practices

• Excellent communication and presentation skills and motivation to lead teams of engineers and chemists through different stages of chemical process development in lab-based execution

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, we’ll 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, including remote and hybrid work arrangements, where possible

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

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