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Process Characterization Engineer (Downstream)
- Regeneron Pharmaceuticals (East Greenbush, NY)
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Regeneron is currently looking for a Process Characterization and Technology Engineer in the Process Sciences Downstream Department. This is a lab based position with a focus on raw materials. Process Characterization and Technology Engineers support production in many ways, including troubleshooting processes, qualifying new raw materials, investigating unexpected results, performing small-scale raw material studies and technical writing. Process Characterization and Technology Engineers will lead and execute lab-based studies with a focus on raw materials to assess the impact of changes to the manufacturing process and document the changes accordingly.
As a Process Characterization & Technology Engineer, a typical day might include the following:
+ Apply engineering and scientific principles to design, execute, document, and present on small-scale experiments to improve process knowledge on downstream raw materials, chromatography, filtration, or stability.
+ Develop a fundamental understanding to assess potential changes/impact to the manufacturing process from a raw material perspective, as a result of change notifications, secondary sourcing, raw material investigations, and risk assessments.
+ Operate AKTA AVANT and AKTA PURE chromatography systems for small scale experiments.
+ Design experiments, procure lab materials, prepare buffers, execute lab experiments, collect data, and present data.
+ Analyze data using a combination of statistics, engineering principles, and other techniques to gain insights into manufacturing process performance.
+ Apply engineering and scientific knowledge in support of process troubleshooting and risk assessments.
+ Present study findings at intra and interdepartmental meetings.
+ Write technical documents to support raw material changes and regulatory updates.
+ Author protocols, reports, technical documents, and risk assessments as they relate to changes from raw materials in the manufacturing process.
This role might be for you if you:
+ Enjoy working in a fast-paced biopharmaceutical laboratory and desk-work environment to support the manufacturing of medicines that address serious diseases in a cGxP setting.
+ Understand chromatography purifications and filtration processes for monoclonal antibodies.
+ Are detail oriented, quality driven, and well organized.
+ Prioritize lab work, reporting and documentation and adapt to constantly evolving business needs.
+ Can take on new and sometimes ambiguous challenges, learn quickly, and train others.
+ Enjoy working in both a team environment and individually leading dynamic projects.
+ Can develop and drive scientific and/or business-related improvement ideas.
+ Have a solid understanding of Microsoft Suite (Word, Excel, PowerPoint).
+ Have experience with technical writing, authoring documents, and contributing to risk assessments.
+ Previous experiences with raw material evaluations is a plus.
To be considered for the Process Characterization and Technology Engineer, you must be willing and able to work Monday-Friday, 8am-4:30pm and occasional off-shift or weekend work as needed. You must have a B.S in Engineering; Chemical Engineering or Biological Engineering preferred.
+ Process Characterization & Technology Engineer: 2+ years of experience
+ Sr Process Characterization & Technology Engineer: 5+ years of experience
+ Or equivalent combination of education & experience
Previous experiences with downstream purifications in a cGxP environment is preferred. Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$66,400.00 - $126,800.00
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