Associate Director of Engineering - Synthetic & Hybrid DS

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 awardwinning 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.

Associate Director of Engineering Synthetic & Hybrid DS

What you will do

Lets do this! Lets 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 onsite 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 processanalytical 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 crossfunctional 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 crossfunctional 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 industryleading medicines that serve patients

• Communicates effectively with others leveraging compassion and the principles of peoplecentered 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

• Associates degree and 12 years of Operations experience OR

• Bachelors degree and 9 years of Operations experience OR

• Masters 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 scaleup and manufacturing of synthetic molecules and hybrid modalities in a regulated environment. This includes technical support for nonconformance investigations and other commercial support activities.

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

• Fluency in labbased execution of and data interpretation for wide variety of analytical methods process analytical tools and solidstate characterization methods including HPLC GC MS NMR FTIR LOD TOC FBRM particle size determination etc.

• Evaluate early and latestage chemical processes to establish and execute labbased prerequisites to enable of bench/kilo laboratory experiments to ensure successful scaleup 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 scaleup 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 scaleup and transfer to manufacturing sites.

• Lead and manage authoring of technical documentation required for process characterization design plans failuremode risk assessments for sciencebased determination of parameter and test criticality engineering scaleup 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 labbased 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 wellbeing. 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 salesbased incentive plan

• Stockbased longterm incentives

• Awardwinning timeoff plans

• Flexible work models including remote and hybrid work arrangements where possible

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

In any materials you submit you may redact or remove ageidentifying 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.

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.

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