Tarrytown, NY, United States
Nov 11, 2020
Required Education
Position Type
Full time
Regeneron's Formulation Development Group is seeking a Scientist, Drug Product Process Development to lead & support process development activities within the group. As a Scientist in this role you will be responsible for planning and executing DP process development activities, developing scale-down models, supporting risk assessments and technology transfer to manufacturing sites. Additionally, the position will be vital in contributing towards setup of in-house drug product (DP) process development capabilities.

A Typical Day Might 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.
  • Independently design, execute and document formulation, fill and finish development studies to understand impact of process parameters on product quality attributes.
  • Support setup of in-house drug product (DP) process development capabilities in Formulations Development Group. Responsibilities include supporting laboratory layout and setup, procuring tools and equipment, coordinating equipment installation and operation and working closely with key members of formulation development, manufacturing and facilities management teams to develop full functionality of DP process laboratory
  • Write complete internal and/or external "publications" that require minimal revisions (i.e., peer reviewed publications, patents, business plans)
  • Routinely author and review guidelines, protocols and reports, regulatory sections, and risk assessments to support technology transfer to manufacturing sites.
  • Present work at group, department and cross functional meetings as a process lead in drug development team meetings.
  • Seek out, recognize and assesses existing and new technologies to improve process development capabilities in Formulations Development Group. Act as a knowledgeable resource on prevalent manufacturing related technologies and processes.
This Role May Be For You If:
  • You have strong initiative and drive to complete challenging tasks and learn new technologies related to DP process development.
  • You are capable of multi-tasking, working both independently and within a team environment.
Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemical or Biomedical Engineering (or related field) with 1-3 years of relevant industry working experience. Experience with drug product (formulation and process) development and characterization is preferred. Proven skill set & understanding in support of GMP manufacturing, quality and regulatory functions. Possesses strong capability with analytical instruments in characterizing protein therapeutics. Hands-on experience and know-how of DP process related unit operations is a plus. Experience in developing and implementing small scale models is highly desirable. Knowledge of Chemometrics, along with Data Science and Process Knowledge also preferred. Excellent oral and written communication skills. Able to work effectively with cross-functional teams in a matrix environment.

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.