Senior Engineer - Process Development - Thousand Oaks, CA
Senior Engineer - Process Development - Thousand Oaks, CA
Posted on :
23-06-2025
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1 Vacancy
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Monthly Salary
$ 147867 - 147867
Vacancy
1 Vacancy
Posted on :
23-06-2025
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
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.
Senior Engineer - Process Development
What you will do
Lets do this. Lets change the world. In this vital role you will be accountable to advance industry leading solutions for the design development and deployment of synthetic and hybrid drug substance manufacturing processes across all phases of development through commercialization. The qualified candidate will be proficient in chemical engineering fundamentals process development & characterization and process safety & scale-up for synthetic processes using both batch and continuous technologies. The Senior Engineer will provide technical leadership for reaction engineering unit operation assessment and technology development &
implementation.
The Senior Engineer will partner with or lead a multi-functional group of engineers and scientists through the process development cycle at Amgen to ensure our process requirements and knowledge are suitable for the intended phase of technology transfer which will include process introduction clinical
manufacturing validation and commercial manufacturing. While working with our manufacturing teams to determine if equipment and manufacturing operations meet process requirements and will collaborate with the production site(s) to introduce new equipment and capabilities.
The Senior Engineer will be responsible for authoring technical reports leading risk assessments and contributing to regulatory documents through all phases of technology transfer and commercialization.
Technical and lab-based execution of bench and kilogram-scale experimentation and process modeling & simulation to design and optimize robust synthetic and hybrid processes.
Critical evaluation of novel chemical processes for the identification of process improvement opportunities and requirements vital to ensure safe and successful scale-up and tech transfer.
Design optimize and deploy process models for reaction kinetics mass transfer separations distillations isolations drying and relevant hydrodynamic operations.
Model and analyze the economic value and environmental impact of process synthetic processes and manufacturing concepts.
Initiate and complete standard practices for technology transfer of synthetic processes which include drafting process transfer documents process fit assessments manufacturing support risk analysis and process documentation.
Represent organization within a multi-functional team to ensure deliverables are aligned with tech transfer timeline such that key achievements are established and achieved.
Apply standard and sophisticated engineering techniques 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.
Routinely monitor manufacturing processes for performance indicators and operations. Lead problem resolution and provide troubleshooting guidance.
Apply engineering principles and statistical analysis including design of experiments in order to critically evaluate chemical processes for identification of process improvements and requirements vital for scale up and tech transfer.
Author review and/or approve of process documentation needed for process validation and commercialization activities.
Contribute to key regulatory and quality activities such as NDAs non-conformances process performance qualification and continued process verification.
Provide on-the-floor support to ensure successful scale-up and facilitate rapid problem solving and decision-making.
Lead or represent department as domain expert for process risk analysis.
Work closely with process development chemists formulation scientists and analytical chemists to generate and interpret data to provide improved understanding and guidance for synthesis and unit operations.
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.
Senior Engineer - Process Development
What you will do
Lets do this. Lets change the world. In this vital role you will be accountable to advance industry leading solutions for the design development and deployment of synthetic and hybrid drug substance manufacturing processes across all phases of development through commercialization. The qualified candidate will be proficient in chemical engineering fundamentals process development & characterization and process safety & scale-up for synthetic processes using both batch and continuous technologies. The Senior Engineer will provide technical leadership for reaction engineering unit operation assessment and technology development &
implementation.
The Senior Engineer will partner with or lead a multi-functional group of engineers and scientists through the process development cycle at Amgen to ensure our process requirements and knowledge are suitable for the intended phase of technology transfer which will include process introduction clinical
manufacturing validation and commercial manufacturing. While working with our manufacturing teams to determine if equipment and manufacturing operations meet process requirements and will collaborate with the production site(s) to introduce new equipment and capabilities.
The Senior Engineer will be responsible for authoring technical reports leading risk assessments and contributing to regulatory documents through all phases of technology transfer and commercialization.
Technical and lab-based execution of bench and kilogram-scale experimentation and process modeling & simulation to design and optimize robust synthetic and hybrid processes.
Critical evaluation of novel chemical processes for the identification of process improvement opportunities and requirements vital to ensure safe and successful scale-up and tech transfer.
Design optimize and deploy process models for reaction kinetics mass transfer separations distillations isolations drying and relevant hydrodynamic operations.
Model and analyze the economic value and environmental impact of process synthetic processes and manufacturing concepts.
Initiate and complete standard practices for technology transfer of synthetic processes which include drafting process transfer documents process fit assessments manufacturing support risk analysis and process documentation.
Represent organization within a multi-functional team to ensure deliverables are aligned with tech transfer timeline such that key achievements are established and achieved.
Apply standard and sophisticated engineering techniques 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.
Routinely monitor manufacturing processes for performance indicators and operations. Lead problem resolution and provide troubleshooting guidance.
Apply engineering principles and statistical analysis including design of experiments in order to critically evaluate chemical processes for identification of process improvements and requirements vital for scale up and tech transfer.
Author review and/or approve of process documentation needed for process validation and commercialization activities.
Contribute to key regulatory and quality activities such as NDAs non-conformances process performance qualification and continued process verification.
Provide on-the-floor support to ensure successful scale-up and facilitate rapid problem solving and decision-making.
Lead or represent department as domain expert for process risk analysis.
Work closely with process development chemists formulation scientists and analytical chemists to generate and interpret data to provide improved understanding and guidance for synthesis and unit operations.
Additional Qualifications/Responsibilities
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The Engineering professional we seek is an individual with these qualifications.
Basic Qualifications:
High school diploma / GED and 10 years of Engineering experience; OR
Associates degree and 8 years of Engineering experience; Or
Bachelors degree and 4 years of Engineering experience; Or
Masters degree and 2 years of Engineering experience; Or
Doctorate degree
Preferred Qualifications:
5 years of engineering experience getting results related to synthetic process development and chemical manufacturing.
Experience in developing and implementing experimental plans to evaluate and develop processes to achieve optimum cost robustness and productivity.
Experience related to technology transfer scale-up and manufacturing of synthetic molecules in a regulated environment. This includes technical support for non-conformance investigations and other commercial support activities.
Experience authoring regulatory documents for commercialization of drug substance processes: CMC Module 3 RTQs and annual reports.
Experience building and applying first-principle models (e.g. reaction kinetics mass transfer separations distillations isolations drying and hydrodynamics) with proficiency across several modeling platforms.
Knowledge of analytical techniques and solid-state characterization with proficiency in a wide variety of methods including HPLC GC MS NMR FTIR LOD TOC FBRM particle size determination etc.
Experience using data science and/or sophisticated statistical analysis to address 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
Strong communication and presentation skills
What you can expect from 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 including remote and hybrid work arrangements where possible
Salary Range
119195.00 USD - 147867.00 USD
Required Experience:
Senior IC
Employment Type
Full Time
Key Skills
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