Regeneron is looking for a Process Sciences Associate for our 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, consistent, and produce quality product, done in part through in-process controls applied to our production processes. This position will be 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 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. This is a non lab oriented position.
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 Regenerons 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 have a bachelors degree in an engineering/life science or related field and the following years of experience required for each level; as is a practical understanding of statistical methods. Experience with downstream chromatography and protein purification preferred.
Process Sciences Associate I: 0-2 years
Process Sciences Associate II: 2+ years
Process Sciences Associate III: 5+ years
Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
$55,700.00 - $121,300.00