Principal Engineer Process Development

  • Clayville, RI

Employment Type

: Full-Time

Industry

: Engineering



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Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that these molecules become medicines. Many of the technologies we're employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping oncology patients., Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Principal Engineer Process Development
Employer
Amgen
Location
Rhode Island, RI, US
Posted
Jul 08, 2019
Ref
R-76319
Discipline
Engineering, Manufacturing & Production, Process
Hotbed
Ideal Employer
Required Education
High School or equivalent
Position Type
Full time
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Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that these molecules become medicines. Many of the technologies we're employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping oncology patients.
Amgen is seeking a Principal Engineer Process Development located at our Rhode Island site reporting to the Director of Process Development. This position will develop network influence by partnering with colleagues in Process Development, Manufacturing, as well as Quality and Information Systems. The role will immerse the staff member in all aspects of operations in a commercial bulk drug facility.
Responsibilities:
* Lead and direct the activities of the downstream process team supporting manufacturing at the Rhode Island site.
* Manage a group that applies extensive technical expertise in the coordination of tech transfers involving the planning, design, and implementation of new products to the manufacturing facility.
* Apply fundamental scientific principles and employs an extensive technical knowledge of process, unit operations, and equipment in complex technology introduction, process characterization, optimization, scale-up, or manufacturing support projects.
* Provide technical support and lead troubleshooting of clinical and commercial drug substance manufacturing. Engage with site to resolve processing issues, and conduct technical assessment on process/product impact due to changes in equipment, scale, and raw materials.
* Design and execute experimentation to support process scale up, perform technical review of data, and author and review GMP documentation.
* Keep current on the latest industrial, scientific and regulatory trends to assist in the review and authorship of relevant sections of global regulatory filings.
Basic Qualifications
* Doctorate degree and 2 years of Process Development experience
* OR
* Master's degree and 6 years of Process Development experience
* OR
* Bachelor's degree and 8 years of Process Development experience
* OR
* Associate's degree and 10 years of Process Development experience
* OR
* High school diploma/GED and 12 years of Process Development experience
Preferred Qualifications
* Advanced Degree in Chemical Engineering, Biochemical Engineering or relevant life Sciences subject with significant experience in the purification of macromolecules.
* Proven ability to manage and deliver results in a highly fluid, interactive matrixed environment
* 10+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing processes.
* 5+ years of experience in engineering in biotech/pharmaceutical industry supporting GMP manufacturing.
* Experience in the creation of regulatory filing sections and regulatory inspections.
* Understands operational aspects of biopharma and/or engineering industries
* 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, and programs or directing the allocation of resources.
* Experience managing a technical group.
* Able to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
* Solid written and verbal communication skills in English.
* Strong communication, relationship building, leadership and mentoring skills
* Ability to prioritize efforts and delegates resources.
* Multi-task project expertise
* Understands operational aspects of biopharma and/or engineering industries
We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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* Doctorate degree and 2 years of Process Development experience * OR * Master's degree and 6 years of Process Development experience * OR * Bachelor's degree and 8 years of Process Development experience * OR * Associate's degree and 10 years of Process Development experience * OR * High school diploma/GED and 12 years of Process Development experience, * Advanced Degree in Chemical Engineering, Biochemical Engineering or relevant life Sciences subject with significant experience in the purification of macromolecules. * Proven ability to manage and deliver results in a highly fluid, interactive matrixed environment * 10+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing processes. * 5+ years of experience in engineering in biotech/pharmaceutical industry supporting GMP manufacturing. * Experience in the creation of regulatory filing sections and regulatory inspections. * Understands operational aspects of biopharma and/or engineering industries * 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, and programs or directing the allocation of resources. * Experience managing a technical group. * Able to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements * Solid written and verbal communication skills in English. * Strong communication, relationship building, leadership and mentoring skills * Ability to prioritize efforts and delegates resources. * Multi-task project expertise * Understands operational aspects of biopharma and/or engineering industries We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.


Associated topics: biochemistry, bioengineering, bioinformatic, biophysics, msat, neuro, neuroscience, pain, pathogenesis, pharmaceutical


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