Process Scientist- Lifecycle Management
Regeneron is looking for a Process Scientist for our IPC (In-Process Controls) Development and Lifecycle Management Team with a Monday – Friday, 8am-4:30pm schedule. Regeneron has successfully commercialized numerous products. Gaining approval from regulatory agencies is dependent on demonstrating that our processes are robust, consistent, and produce quality product, done in part through in-process controls applied to our production processes. In this role you will write and review documents that support Manufacturing, Quality Control, and CMC Regulatory Departments. The Process Scientist develops, manages, and maintains the IPC program for each product. In this fast-paced environment with a strong pipeline, scientists in Process Sciences have an opportunity to work on various aspects of the process and business.
As a Process Scientist, a typical day might include the following:
- Working with a multi-functional team to support technology transfer and scale-up of processes from Regeneron’s process development team
- Analyzing development studies, enrichment studies, process validation and characterization studies, chemical stability studies, and/or historical manufacturing data to support development of process control programs.
- Evaluating product and process risks and providing justification for implementing process controls or for making updates to existing process control programs.
- Assessing criticality of product attributes to support the creation of product specifications.
- Drafting process control documents, including Process Control Strategy documents, In-Process Control (IPC) Development Reports, and Process Performance Monitoring Plans, including setting relevant limits using appropriate scientific rationale or statistical analysis, where appropriate.
- Coordinating with team members to obtain additional data as needed to create, update, and make changes to the process control programs.
- Presenting process control program structure, rationale, and methodologies during multi-functional meetings and to senior leadership when required.
- Participating in brainstorming sessions where we look for ways to continuously improve our Process Control Development and Lifecycle Management processes.
This role might be for you if you:
- Understand antibody manufacturing processes. You have in-depth knowledge of liquid chromatography; experience in analytical chemistry, pharmaceutical sciences and protein characterization using a variety of analytical tools for solution-based analyses.
- Enjoy working in a fast-paced environment.
- You are diligent, quality-driven, and well organized.
- You have the dedication to balance multiple projects. Prioritize, and complete them independently while excelling at keeping all impacted parties well informed.
- Can take on new and sometimes ambiguous challenges, learning quickly.
- Detail-oriented, good interpersonal and effective technical writing and verbal communication skills.
- You enjoy working in a team environment but can also take ownership of multi-faceted projects and technical reports.
- Can develop and drive scientific and/or business-related improvement ideas.
- Have a solid understanding of Microsoft Suite (Word, Excel, PowerPoint).
To be considered for the Process Scientist you must be willing and able to work Monday-Friday, 8am-4:30pm. For various levels you must have the following:
Process Scientist: PhD in an engineering/life science or related field; Chemical Engineering or Biochemistry preferred
Sr. Process Scientist: PhD in an engineering/life science or related field; Chemical Engineering or Biochemistry preferred and 2+ years of relevant experience
Experience with liquid chromatography and/or protein purification and a practical understanding of statistical methods is required. Level is determined based on qualifications relevant to the role.