Process Sciences Associate (Downstream)

Rensselaer, NY, United States
Jun 27, 2019
Required Education
Masters Degree/MBA
Position Type
Full time
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: Supports scientific investigations, manufacturing monitoring, and technology enhancements related to production processes for biological drugs.

Essential Duties and Responsibilities may include, but are not limited to, the following:

• Performs root cause analysis in manufacturing investigations related to downstream unit operations of biologics manufacturing processes.

• Drafts study protocols and author study reports for manufacturing support and scientific studies.

• Conduct small-scale lab operations; perform statistical analysis of data, and present results in cross-functional meetings.

• Performs scientific investigations (EOE & DNF).

• Provides technical support for manufacturing operations.

• Serves as a subject matter expert (SME) for manufacturing downstream operations, data analysis and manufacturing support activities.

• Support Material Science and raw material evaluation and control plan by conducting technical assessment and lab-scale experiments.

• Provide support to scale down model development and perform DOE experiments.

• Develop statistical process control and modeling tools for manufacturing investigations and manufacturing process control.

• Participates in process and quality risk assessments.

• Participated in tech transfer activities.

• Reviews and/or approves Manufacturing documentation associated with the transferred process.

• Conduct formulation and stability studies to support regulatory filing.

• Support Process Microbiology Lab activities for manufacturing investigations.

• Support Process Analytical Technology (PAT) in developing new software and statistical process modeling tools.

• Participated in new technology initiative efforts and continuous improvement projects.

• Knowledge/experience about high-throughput technology for downstream applications is desirable.

Knowledge, Skills & Abilities:

• Lab skills in protein separation, filtration and purification.

• Scale-down model development.

• Raw material controls.

• JMP and advanced statistical software programs.

• Interpersonal, oral, and written communication skills;

• Word processing, spreadsheet, database management, statistical analysis, graphing, and presentation programs.

• cGMP operations.

• Process microbiology.

• Protein formulation and stability.

• Computer programming and software development.

• Process statistics and modeling.

Education and Experience:

• Requires BS chemical engineering, biochemistry, life sciences or related discipline with 2+ years of relevant experience; MS with 1+ years of relevant experience.

• Experience working in a purification sciences team, knowledge of protein separation techniques, experimental design and data analysis using advanced mathematical tools required.

• Knowledge of complex raw material chemistry and experience in the identification of chemical markers is beneficial.

*Level will be determined by education and 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.