Engineer, Drug Product Process Engineering - Thousand Oaks, CA bei Amgen
Amgen · Thousand Oaks, Vereinigte Staaten Von Amerika · Onsite
- Professional
- Optionales Büro in Thousand Oaks
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 to Veterans, 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 you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
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.
Engineer, Drug Product Process Engineering
What you will do
Let’s do this! Let’s change the world!
The Engineer will join Drug Product Process Engineering team that is part of Commercial Drug Product Technologies at Amgen and will be a key contributor to drug product process development, commercialization, and life cycle management of Amgen’s parenteral product portfolio. The Engineer will be responsible for integrating the knowledge and information generated by cross functional teams with Amgen’s platforms and clinical and/or commercial manufacturing capabilities to ensure success through the commercialization lifecycle. The Engineer will operate in product/process development and aseptic manufacturing environments in a highly matrixed cross functional manner. This position is based in Thousand Oaks, CA at the Amgen headquarters. This role is primarily a first-shift role but may require some time on call during second or third shifts.
In this role, the Engineer will:
Work with a team of process scientists and/or engineers to design, execute, document, and generate primary data packages related to process development and technology transfer, while developing and applying their experience in aseptic processing, equipment, automation and unit operation characterization
Support continuous improvements in the drug product development process through technological innovation and application of first principles in process engineering
Support technology transfers of pipeline and commercial products as well as lifecycle management of products for a variety of parenteral modalities
Conduct make-a-batch exercises to determine facility fit and identify gaps
Design and execution of offline and on-site drug product characterization studies
Evaluation of product impact from manufacturing process, production scale, equipment, and raw material changes
Author and/or own high-quality process technology transfer and other technical documents
This role provides development opportunities in the following areas:
Dynamic, matrixed organization and collaboration – the Engineer interfaces with a broad array of partners on a routine basis, providing visibility to those other areas of the business and how these functions work together to meet organizational goals.
Operational efficiency and business skills application – this role provides an opportunity to apply core technical skills to Amgen’s process development operations.
Process development – Provide technical input and support to the drug product tech transfer process by executing development studies including filling recipe development, lyophilization process scale-up etc.
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
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.
Engineer, Drug Product Process Engineering
What you will do
Let’s do this! Let’s change the world!
The Engineer will join Drug Product Process Engineering team that is part of Commercial Drug Product Technologies at Amgen and will be a key contributor to drug product process development, commercialization, and life cycle management of Amgen’s parenteral product portfolio. The Engineer will be responsible for integrating the knowledge and information generated by cross functional teams with Amgen’s platforms and clinical and/or commercial manufacturing capabilities to ensure success through the commercialization lifecycle. The Engineer will operate in product/process development and aseptic manufacturing environments in a highly matrixed cross functional manner. This position is based in Thousand Oaks, CA at the Amgen headquarters. This role is primarily a first-shift role but may require some time on call during second or third shifts.
In this role, the Engineer will:
Work with a team of process scientists and/or engineers to design, execute, document, and generate primary data packages related to process development and technology transfer, while developing and applying their experience in aseptic processing, equipment, automation and unit operation characterization
Support continuous improvements in the drug product development process through technological innovation and application of first principles in process engineering
Support technology transfers of pipeline and commercial products as well as lifecycle management of products for a variety of parenteral modalities
Conduct make-a-batch exercises to determine facility fit and identify gaps
Design and execution of offline and on-site drug product characterization studies
Evaluation of product impact from manufacturing process, production scale, equipment, and raw material changes
Author and/or own high-quality process technology transfer and other technical documents
This role provides development opportunities in the following areas:
Dynamic, matrixed organization and collaboration – the Engineer interfaces with a broad array of partners on a routine basis, providing visibility to those other areas of the business and how these functions work together to meet organizational goals.
Operational efficiency and business skills application – this role provides an opportunity to apply core technical skills to Amgen’s process development operations.
Process development – Provide technical input and support to the drug product tech transfer process by executing development studies including filling recipe development, lyophilization process scale-up etc.
Job_Category
Engineering
Minimum Education Required
High School/GED
City*
Thousand Oaks
Additional Qualifications/Responsibilities
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:
High school diploma / GED and 8 years of Operations or Process Development experience OR
Associate’s degree and 6 years of Operations or Process Development experience OR
Bachelor’s degree and 2 years of Operations or Process Development experience OR
Master’s degree
Preferred Qualifications:
M.S. in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related discipline
Experience in a role that working with cross functional groups to achieve results.
Highly proficient in presentation skills and the ability to draft technical documents.
Familiarity with aseptic processing, drug product manufacturing, cGMPs, statistical design, analysis of experiments, and process characterization
Fill/finish process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools
The ability to use engineering principles to leverage bench and pilot scale models for process performance characterization
Knowledge of formulation, filling, lyophilization, visual inspection, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling and the associated GMP/Device documentation and regulatory filings
Highly proficient in presentation skills and the ability to draft technical documents.
Ability to learn and act on dynamic information at a rapid pace
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
Strong experience in a matrix team environment, interacting with Attribute Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and Quality
Salary Range
93,344.00 USD - 107,268.00 USD
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:
High school diploma / GED and 8 years of Operations or Process Development experience OR
Associate’s degree and 6 years of Operations or Process Development experience OR
Bachelor’s degree and 2 years of Operations or Process Development experience OR
Master’s degree
Preferred Qualifications:
M.S. in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related discipline
Experience in a role that working with cross functional groups to achieve results.
Highly proficient in presentation skills and the ability to draft technical documents.
Familiarity with aseptic processing, drug product manufacturing, cGMPs, statistical design, analysis of experiments, and process characterization
Fill/finish process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools
The ability to use engineering principles to leverage bench and pilot scale models for process performance characterization
Knowledge of formulation, filling, lyophilization, visual inspection, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling and the associated GMP/Device documentation and regulatory filings
Highly proficient in presentation skills and the ability to draft technical documents.
Ability to learn and act on dynamic information at a rapid pace
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
Strong experience in a matrix team environment, interacting with Attribute Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and Quality
Salary Range
93,344.00 USD - 107,268.00 USD
State*
California
Salary Range
$75,000-$100,000
