Regeneron's Bioreactor Development group, located in Tarrytown, NY and which scales-up Cell Culture processes for our Preclinical Manufacturing and Process Development (PMPD) organization at the company, is are seeking an Process Development Associate II. In this role you will be primarily involved in developing clinically-enabling bioreactor processes intended for use in cGMP manufacturing and in resolving critical problems in Upstream Bioreactor Development and Scale-Up.
A Typical Day in the Role Might Look Like:
This Job May Be For You If:
- Cultivate mammalian cells using aseptic technique in bench and pilot scale bioreactors to produce monoclonal antibodies.
- Evaluate and troubleshoot the scale-up of processes in support of clinical productions.
- Analyze seed train, production, and quality data in support of process understanding and technology transfer, followed by the authoring of development reports, process transmittals and documentation in electronic notebooks
- Participate on Technology Transfer Start-Up Teams, which include technology transfer via written process transmittals and virtual and on-site support to our manufacturing facility in Albany, NY during clinical production campaigns.
- Support technology development and improvement initiatives, specifically assisting with Raman spectroscopy development. Identify value adding opportunities for improvement and propose potential solutions.
- Produce various nonclinical reagents in support of Regeneron's Research and Development activities.
- Execute experiments/projects and analyze data alone or in collaboration with others
- Link scientific literature and technical documentation to ongoing development
- Maintain scientifically current (state of the art) laboratory environment and/or product inventory. Maintain accurate and complete records consistent with company policy and legal requirements.
- Possess cross-functional knowledge and skills and contribute within his/her own functional area.
- You contribute to lab equipment maintenance and safety to help create a safe, effective and efficient working environment.
- You anticipate and recognize potential problems with laboratory supplies / equipment and act to prevent and solve problems.
- You adhere to SOP training and/or compliance responsibilities.
- You can assist with managing departmental product inventory and distribution within Regeneron and to collaborators.
This role requires a BS/MS in an Engineering field with 0-3+yrs industrial experience. Experience with NOVA FLEX, Sartorius Biostat DCU Bench top Bioreactors, Applikon bench top bioreactors, WAVE bioreactors, ABEC/Hyclone Single Use Bioreactors (50-500L), ABEC Stainless Steel Pilot Scale (40-500L) bioreactors, Medium Prep skid, CIP, Biosafety cabinets, incubators, autoclave, Perfusion Bioreactor, Continuous Processing, SynTQ, PI Historian, JMP, LIMS, Kepware, SIMCA, Raman spectroscopy is a plus.
Please clearly state your GPA on your CV.
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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.