Sr Process Scientist (Downstream)

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.

Job Summary and Essential Functions:

Process Scientist will support scientific investigations and perform small scale studies related to production processes for biological drugs. Essential Duties and Responsibilities may include, but are not limited to, the following:

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

• Draft 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

• Perform scientific investigations (EOE & DNF)

• Provide technical support for manufacturing operations

• Serve 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

• Participate in process and quality risk assessments

• Participate in tech transfer activities

• Review 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

• Participate in new technology initiative efforts and continuous improvement projects

• Responsible for leading, coaching, and developing direct reports

Knowledge, Skills & Abilities:

• Lab skills in protein separation, filtration and purification

• Scale-down model development

• Raw material controls

• Protein formulation and stability

• Process microbiology

• Design of experiment, and advanced statistical analysis

• Process statistics and modeling

• cGMP operations

• Word processing, spreadsheet, database management, graphing, and advanced presentation

• Project management, interpersonal, cross-cultural, communication, negotiation and problem solving skills

• Ability to maintain integrity and honesty at all times

• Ability to work independently or as part of a team

• Ability to communicate with transparency

• Continuously drive to improve processes for improved performance

• Demonstrate respectful behavior at all times

• Accountable for technical performance and results of team

• Manage internal and external relationships

• Develop strategy and create metrics to measure effectiveness of strategy

• Translate ambiguity into actionable steps

• May manage others through influence rather than direct authority

• Ability to resolve conflicts and coach others on problem solving

• Handle issues appropriately and with a sense of urgency

• Prioritize based on business needs

• Identify and effectively communicate risks

• Ability to problem solve and identify root cause

#LI-KS1

Education and Experience:

PhD in chemical engineering, biochemistry, or related discipline with 3+ years of relevant experience.

Experience in working in a purification sciences team, knowledge of protein separation techniques, experimental design, data analysis using advanced mathematical tools, materials science, and protein formulation and stability is required. Knowledge of microbiology and complex raw material chemistry and experience in the identification of chemical markers is beneficial. Candidate will support programs that reflect best practices in the industry.
Managerial experience is highly desired

Level of Scientist to be determined based upon 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.