We are seeking a highly-motivated Sr. Scientist to join the Process Development (PD) team within the Formulations Development Group (FDG)of Regeneron Pharmaceutical Inc. at Tarrytown, NY.
You will be responsible for planning and driving Drug Product (DP) process development activities across our genetic medicines and biologics pipeline. This will entail supporting risk assessments and technology transfer to manufacturing sites, developing scaled-down models, and contributing towards setup of in-house drug product process development capabilities. The PD team supports programs across all stages of clinical development and provides technical leadership towards clinical & commercial drug product process development and technology transfer. We provide technical support towards GMP manufacturing, engineering and validation campaigns as well as life cycle management activities for drug products.
The candidate will play a vital role in maintaining efficient lab operations by overseeing, managing, and optimizing the laboratory operations of our Drug Product Pilot Facility (DPPF). In addition to the DP process responsibilities, you will be responsible for ensuring smooth and effective lab functioning, making their contribution integral to our overall success.
A day as a Senior Scientist may look like:
- Lead and support DP process development activities for different unit operations across multiple programs. Responsibilities also include supporting implementation of small-scale models to ensure effective characterization of different unit operations and ensuring a seamless technology transfer to the manufacturing sites.
- Support setup of in-house drug product (DP) process development capabilities in FDG. Responsibilities include supporting laboratory layout and setup, updating and optimizing inventory, procuring tools and equipment, overseeing equipment installation and operation, and working closely with key members of formulation development, manufacturing and facility management teams to develop full functionality of DP process laboratory.
- Design, deliver, and document fill and finish development and research studies to understand impact of process parameters on product quality attributes.
- Lead, review, and complete project plans supported by strong scientific rationales and technical approaches.
- Ensure strong strategic partnerships & communication with colleagues from Research Groups, Drug Product & Drug Substance Manufacturing (internal and external partners, CMOs), Project Management, Regulatory Sciences, and Quality.
- Be an effective communicator and remain cognizant of both project work (e.g., reports, memos, presentations) and timelines.
- Participate in scientific conferences and forums to seek out, recognize and assesses new technologies to facilitate efficient and robust process development within FDG.
This role may be for you if:
- You have experience with drug product formulation and process development and characterization.
- You have experience overseeing lab activities, coordinating maintenance, and optimizing workflows.
- Experience in developing and implementing small scale models (computational and empirical).
- Collaborate closely with multi-functional teams to support manufacturing activities and process improvement initiatives.
- Experience in lab management or related roles.
- Experience in designing, executing, and reporting research studies.
- Experience in fill-finish activities including environmental monitoring, design of media fill, and execution of smoke studies is a plus.
- Excellent oral and written communication skills.
In order to be considered qualified for this role, you must have a degree in Pharmaceutical Sciences, Pharmaceutics, Chemical or Biomedical Engineering, or related field. Will consider a PhD with 0-3 years of relevant industry working experience, or a BS/MS with 8+ years of relevant experience.
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)