Process Development Engineer II - Synthetic and Bioconjugation Scale-Up Technologies (SBST)

Regeneron develops life-changing medicines for people with serious diseases. The Process Development Engineer II will develop scalable, GMP-ready bioconjugation and purification processes, apply Quality by Design and statistical design of experiments, and support technology transfer and scale-up to manufacturing partners or internal suites. The role also involves cross-functional collaboration, data analysis, documentation, and mentoring junior team members.

Responsibilities

• Works at the bench to design and develop scalable, robust and controlled GMP-ready bioconjugation and purification processes
• Collaborates with analytical groups within or outside the organization to establish supportive analytical characterization techniques
• Discusses plans and data in cross-functional teams to evaluate processes and determine developmental goals, ensuring integrated program success
• Proactively complies with lab safety and environmental safety expectations of both Regeneron and regulatory bodies such as the FDA and Department of Transportation (DoT)
• Uses statistical design of experiments (DOE) to optimize bioconjugation processes, including conjugation reactions, purification operations, and analytical characterization
• Partners with the External Manufacturing group and other key partners at Regeneron's IOPS organization to provide technical assessment of CDMOs intended for GMP production, successfully transferring processes with immediate, first-time success
• Researches, identifies, and develops new technologies to improve processes, generate predictive process models, and pioneer novel at-line/in-line process analytical technologies (PAT)
• Authors robust technology transfer documentation and supports production with onsite presence during scale-up/GMP manufacturing activities
• Analyzes and presents data in a clear and cohesive manner to a broad audience, facilitating data-driven decision making
• Authors, reviews, or provides domain expertise for publications, reports, tech transfer documents, regulatory support documents, and patents
• Acts as a responsible lab citizen by ensuring timely maintenance of lab equipment, keeping the lab tidy and organized, and proactively planning for lab resources
• Coaches and mentors junior team members of the organization as needed

Preferred

• Experience with antibodies in the bioconjugates space is highly preferable
• Hands-on experience with bioconjugation processes (lysine-based, cysteine-based, site-specific, etc.) with practical knowledge of downstream purification techniques such as chromatography, ultrafiltration/diafiltration, and membrane technologies is preferred
• Experience with a variety of analytical characterization tools such as electrophoresis, mass spectrometry, high-performance liquid chromatography (HPLC), and UV spectroscopy is preferred
• Antibodies experience
• Bioconjugation processes
• Downstream purification techniques
• Chromatography
• Ultrafiltration
• Diafiltration
• Membrane technologies
• Analytical characterization tools
• Electrophoresis
• Mass spectrometry
• High-performance liquid chromatography
• UV spectroscopy

Benefits

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Insurance benefits (e.g. medical, dental, vision, life and disability)
• Paid time off
• Family support benefits
• Onsite, full-time

Company

• Develops and commercializes biopharmaceutical medicines for serious diseases
• Tarrytown, New York, USA
• http://www.regeneron.com/
• Founded in 1988
• 10001+ employees

Qualifications

• Bachelor's degree + 5-6 years relevant experience, or Master's degree + 3-4 years relevant experience, in chemical/biochemical engineering or a related field
• Strong initiative with the drive to complete challenging tasks and learn new technologies
• Strong fundamental understanding of protein purification and technology transfer principles
• Capable of multi-tasking and working both independently and in a collaborative, cross-functional environment
• Excellent interpersonal, verbal, and written communication skills
• Strong critical thinking and problem-solving skills
• Experience with antibodies in the bioconjugates space is highly preferable
• Hands-on experience with bioconjugation processes (lysine-based, cysteine-based, site-specific, etc.) with practical knowledge of downstream purification techniques such as chromatography, ultrafiltration/diafiltration, and membrane technologies is preferred
• Experience with a variety of analytical characterization tools such as electrophoresis, mass spectrometry, high-performance liquid chromatography (HPLC), and UV spectroscopy is preferred

Required skills

• , Bioconjugation Processes, Protein Purification, Chromatography, Ultrafiltration/Diafiltration, Electrophoresis, Mass Spectrometry, High-Performance Liquid Chromatography (HPLC), UV Spectroscopy, Design of Experiments (DOE), Technology Transfer, Antibody Bioconjugates

Experience

• 3-4 years