Process Development Engineer - Bioreactor Scale-Up and Development

Location
Tarrytown, New York, US
Posted
May 19, 2018
Ref
12373BR
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:
We are seeking a Process Development Engineer to work in the Bioreactor Scale-Up and Development group within Pre-Clinical Manufacturing and Process Development. This person will be primarily involved in developing clinically-enabling bioreactor processes intended for use in cGMP manufacturing.

Responsibilities:
• Cultivation of mammalian cells using aseptic technique in bench and pilot scale bioreactors for the production of monoclonal antibodies.
• Scale-up process evaluation and troubleshooting in support of clinical productions.
• Detailed data analysis of seed train, production, and quality data in support of process understanding and technology transfer followed by authoring of development reports and process transmittals and documentation in electronic notebooks
• Active involvement in Technology Transfer Start-Up Teams, which includes technology transfer via written process transmittals and on-site support to our manufacturing facility in Albany, NY during clinical production campaigns.
• Supports technology development and improvement initiatives. Identifies value adding opportunities for improvement and proposes potential solutions.
• Production of various nonclinical reagents in support of Regeneron's Research and Development activities.
• Utilizes subject matter expertise to design, lead, and react to experiments/projects with minimal guidance. Designs and conducts experiments independently and effectively prioritizes tasks. Draws conclusions and proposes next steps. Develops novel procedures.
• Consistently incorporates scientific literature and technical documentation to ongoing development independently.
• Technical writing and presentations to senior management are lucid and succinct with clear line of sight between hypothesis and conclusion
• Responsible for maintaining scientifically current (state of the art) laboratory environment and/or product inventory. Maintains accurate and complete records consistent with company policy and legal requirements.
• Has cross-functional knowledge and skills, contributes within his/her own functional area.
• Contributes to lab equipment maintenance and safety to help create a safe, effective and efficient working environment.
• Anticipates and recognizes potential problems with laboratory supplies / equipment and acts to prevent and solve problems.
• Keep up with SOP training and/or compliance responsibilities.
• Assist with managing departmental product inventory and distribution within Regeneron and to collaborators.
Requirements:
The ideal candidate will have a Bachelors or Masters degree in either Chemical Engineering, Biochemical Engineering, or Biochemistry (3.0 or better GPA strongly preferred), and 0 - 2 years experience in the biotech or pharmaceutical industry.

Experience with Cultivation of mammalian cells using aseptic technique in bench and pilot scale bioreactors for the production of monoclonal antibodies strongly preferred.

Experience with any of the below preferred:
NOVA FLEX
Bench top Bioreactors (Sartorius Biostat DCU, Applikon, WAVE)
Single Use and/or Pilot Scale Bioreactors
Medium Prep skid
SIP
Incubators
Raman Spectroscopy
LIMS

Level will be commensurate with experience.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

Requisition Number: 12373BR