Regeneron
Biotechnology
ProcessDevelopmentAssociate,SyntheticandBioconjugationScale-UpTechnologies(SBST)(1of2)
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Process Development Associate, Synthetic and Bioconjugation Scale-Up Technologies (SBST) (1 of 2) at Regeneron. Skills: Bioconjugation, Purification processes, Technology transfer. Develop conjugation processes. Develop purification processes”
What You'll Achieve.
Ensure timely entrance to clinic; Ensure product commercialization; Ensure integrated program success; Ensure robust processes; Ensure controllable processes; Achieve first-time success
Industry & Context.
Problem-solving skills
What They're Looking For.
Must Have
Bachelor's + 0-3 years experience, Chemical/Biochemical engineering degree
Nice to Have
Antibodies in bioconjugates experience, Hands on bioconjugation processes experience, Practical knowledge of downstream purification techniques, Experience with variety of analytical characterization tools
What You'll Do.
Develop conjugation processes
Develop purification processes
Technology transfer workflows
Design scalable processes
Develop GMP-ready processes
Collaborate with analytical groups
Establish analytical techniques
Determine developmental goals
Comply to environmental safety
Use statistical design of experiments
Optimize bioconjugation processes
Provide technical assessment
Research new technologies
Identify new technologies
Develop new technologies
Generate predictive process models
Author technology transfer documentation
Support production during scale-up
Support GMP manufacturing
Provide domain expertise
Maintain lab equipment
Coach junior team members
Mentor junior team members
How You'll Work.
Team & Collaboration
Cross-functional teams; External Manufacturing group; IOPS organization
Communication Scope
Presenting data; Technical writing
Full Job Description
Regeneron's Preclinical Manufacturing & Process Development group (PMPD), located in Tarrytown NY, is seeking a hardworking and dynamic **Process Development Associate** for its new Synthetic and Bioconjugation Scale-up Technologies (SBST) group. In this exciting new role, you will develop conjugation and purification processes for bioconjugation of proteins to a diverse range of small-molecules. You would work in close collaboration with cross-functional teams for process development and optimization using the principles of Quality by Design (QbD) to make the processes suitable for GMP production. This role also involves process scale-up and technology transfer of manufacturing related workflows to Contract Development and Manufacturing Organizations (CDMOs) or Regeneron based manufacturing suites to ensure timely and reliable entrance to the clinic through product commercialization. ## **A typical day in the role of Process Development Associate II might include:** * Working at the bench to design and develop scalable, robust and controlled GMP-ready bioconjugation and purification processes. * Collaborating with analytical groups within or outside the organization to establish supportive analytical characterization techniques. * Discussing plans and data in cross functional teams to evaluate processes and determine developmental goals and ensure integrated program success. * Proactively complying to lab safety and environmental safety expectations of both Regeneron and regulatory bodies such as Food and Drug Administration (FDA), Department of Transportation (DoT), etc. * Using statistical design of experiments (DOE) to optimize bioconjugation processes including conjugation reactions, purification operations, and analytical characterization. * Partnering with External Manufacturing group and other key partners at Regeneron’s IOPS organization to provide technical assessment of CDMO’s intended for GMP production and successfully transferring processes with immedi
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