Sr. Scientist - Drug Product Process Development (siRNA & mAb)

Regeneron Pharmaceuticals•Tarrytown, GA

7d•$109,900 - $179,300•Onsite

About The Position

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a highly motivated Sr. Scientist to join our Process Development (PD) team within the Drug Product Development and Technology (DPDT) department. In this role, you will plan and execute drug product (DP) process development activities, developing cross-scale models, supporting risk assessments, and leading technology transfer to manufacturing sites, while helping set up in-house drug product process development capabilities. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Requirements

Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemical or Biomedical Engineering (or related subject area) with 0-3 years of relevant industry working experience, a MS with 8+ years, or a BS with 10+ years
Ability to work effectively in a team environment and capacity to quickly adapt to changes in project direction
A consistent record of publications with creative, productive, and insightful statistical-based analysis
Excellent oral/written communication skills and interpersonal skills to support frequent interactions with collaborators

Nice To Haves

Experience with biologics drug product (formulation and process) development and characterization
Strong capability with analytical instruments in characterizing protein therapeutics
Proven skills and understanding in support of GMP manufacturing, quality, and regulatory functions
Hands-on experience and know-how of DP process related unit operations
Experience in developing and implementing small-scale models

Responsibilities

Lead DP process development activities for different unit operations across multiple programs (with a focus on siRNA and mAb drug products)
Support implementation of cross-scale models to successfully bridge the gap between lab and manufacturing while supporting the increasing pipeline of new modalities
Ensure effective characterization of different unit operations for a seamless technology transfer to the manufacturing sites
Support setup of in-house DP process development capabilities in the Formulations Development Group, including laboratory layout and setup, procuring tools and equipment, overseeing equipment installation and operation, and working closely with formulation development, manufacturing, and facility management teams to develop full functionality of the DP process laboratory
Independently design, execute, and document formulation, fill and finish development studies to understand the impact of process parameters on product quality attributes
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, and contribute as a process lead in drug development team meetings
Seek out, recognize, and assess existing and new technologies to improve process development capabilities in the Formulations Development Group, serving as a knowledgeable resource on prevalent manufacturing-related technologies and processes