Process Associate jobs in Albany, NY

Regeneron is looking for a Process Sciences Associate for our Process Controls Development and Lifecycle Management Team. Regeneron has successfully commercialized numerous products. Gaining approval from regulatory agencies is dependent on demonstrating that our processes are robust, and consistent, and produce quality product, done in part through in-process controls applied to our production processes. This is a non-lab-based position that is responsible for writing and reviewing documents that support Manufacturing, Quality Control, and CMC Regulatory Departments. As a Process Sciences Associate, you will be developing, leading, and maintaining the In-Process Control (IPC) program for each product. In this fast-paced environment with a strong pipeline, associates in Process Sciences have an opportunity to work on various aspects of the process and business.

In this role, 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 stakeholders to acquire additional data as needed to support the creation, updates, and changes to process control programs.

• Communicating 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 thorough, quality-driven, and well organized.

• You have the dedication to balance multiple projects and prioritize and implement them independently while excelling at keeping all impacted parties well advised.

• 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 complex 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 Sciences Associate you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a bachelor’s degree in an engineering/life science or related field; Chemical Engineering or Biochemistry preferred, as is a practical understanding of statistical methods. For various levels you must have the following:

• Process Sciences Associate I: 0-2 years

• Process Sciences Associate II: 2 years

Experience with downstream chromatography and protein purification preferred. Level is determined based on qualifications relevant to the role.