Process Development Engineer II - Synthetic and Bioconjugation Scale-Up Technologies (SBST)
$93,900.00 - $153,300.00
ApplyProcess Development Engineer II - Synthetic and Bioconjugation Scale-Up Technologies (SBST)
Posted 18 days ago
SENIORITY
Lead
SALARY
$93,900.00 - $153,300.00
About the role
- Tarrytown, NYWork model/flexibility: Onsite, full-time
- Discover your role: 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
- This role requires: 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
- 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
- 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#pmpd
- Does this sound like you?
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