Job ID: 289602798
Last Updated: 7/31/2018
Scientist (Drug Product/Formulation Development)
Regeneron Pharmaceuticals, Inc.
Accepts J-1 Visas
We are seeking a Scientist to lead & support process development activities within the Formulations Development Group of Regeneron Pharmaceutical Inc. at Tarrytown, NY.
The Scientist 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 contribute towards setup of in-house drug product (DP) process development capabilities.
Leads 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.
Supports 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, 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.
Independently designs, executes and documents formulation, fill and finish development studies to understand impact of process parameters on product quality attributes.
Writes complete internal and/or external "publications" that require minimal revisions (i.e., peer reviewed publications, patents, business plans)
Routinely authors and reviews guidelines, protocols and reports, regulatory sections, and risk assessments to support technology transfer to manufacturing sites.
Presents work at group, department and cross functional meetings, and contributes as a process lead in drug development team meetings.
Seeks out, recognizes and assesses existing and new technologies to improve process development capabilities in Formulations Development Group. Contributes as a knowledgeable resource on prevalent manufacturing related technologies and processes.
Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemical or Biomedical Engineering (or related discipline) with 1-3 years of relevant industry working experience.
Experience with drug product (formulation and process) development and characterization is preferred.
Demonstrated 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.
Excellent oral and written communication skills
Able to work effectively with cross-functional teams in a matrix environment.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regenerons unwavering commitment to combining good science & good business.
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