Sr. R&D Specialist - FDG Process Development
We are seeking a Sr. R&D Specialist to lead & support process development activities within the Formulations Development Group of Regeneron Pharmaceutical Inc. at Tarrytown, NY.
In the role of Sr. R&D Specialist you will lead 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 lab operation & expansion of in-house drug product (DP) process development capabilities.
A Typical Day in the Role of Sr. R&D Specialist May Look Like:
•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 DP Process lab operation and expansion 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 facility management teams to support full functionality of DP process laboratory.
•Independently designs, executes and documents formulation, fill and finish (e.g. freeze-thaw, mixing, filtration, filling) development studies to understand impact of process parameters on product quality attributes.
•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.
This Role Might Be For You If:
•You have strong initiative and drive to complete results-oriented tasks and learn new technologies related to DP process development.
•You are capable of multi-tasking, working both independently and within a team environment.
This role requires a Bachelors or Masters in Pharmaceutical Sciences, Pharmaceutics, Chemical or Biomedical Engineering (or related field) with 8+ years (Bachelors) or 5+ years (Masters) of relevant industry working experience. Experience with drug product (formulation and process) development and characterization. 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. Experience in developing and implementing small scale models is highly desirable.
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.