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Village of Tarrytown, New York, United States
Onsite
Regeneron's Drug Product Development & Technology is seeking a Senior Associate Scientist as we work to support all stages of pre-clinical, clinical, commercial formulation, and drug product development for various drug product modalities. In this role, you will apply biochemical and biophysical methods to carry out developability assessment and formulation development studies on monoclonal antibody-based therapeutics, to support drug substance and drug product development.
Job Duties:
Design and independently execute phase-appropriate formulation development studies, such as formulation screening, stability and compatibility studies, to support drug product development for early and late-stage development programs.
Conduct pre-formulation studies for monoclonal antibodies, bioconjugates and peptides, using various biophysical and biochemical techniques to identify critical quality attributes for formulation and drug product development.
Develop analytical methods for drug products, with primary focus on peptides, and supporting focus on antibody–drug conjugates, siRNA, monoclonal antibodies, and bispecific antibodies
Develop and qualify analytical methods for critical quality attributes to support formulation development, DP process development, and stability testing for programs in preclinical and clinical stage.
Characterize drug product formulation to support the process development and manufacturing of clinical drug substances and drug products.
Document findings and lab records in electronic laboratory notebook by following the organizational best practices and policies.
Contribute to formulation development technical reports to provide insights into process development and manufacturing of clinical drug substances and drug products.
Participate in meetings and present study results in cross-functional team meetings or department meetings.
Author protocols, technical documents for internal use and support regulatory filings.
Take part in the general laboratory and instrument maintenance.
Take direction and guidance for data-driven decision making, priority setting and technical problem solving.
Generate and organize data figures and data tables in a clear and insightful way
Communicate critical data in timely manner to supervisor and team
Strong ability to prioritize and manage multiple tasks effectively.
Highly organized, detail-oriented, self-motivated, effective team player.
Excellent oral and written communication skills.
This role requires a B.S or M.S degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Biophysics, Biomedical Engineering, Analytical Chemistry, Chemical Engineering, or a related discipline with at least 3 years of industrial experience. The ability to design and execute experiments, as well as interpret, document, and communicate results with minimal supervision is required. Strong technical knowledge base and relevant experience with protein/peptide chemistry, biophysical/biochemical characterization of proteins, bioanalytical method development and biomolecule product development is desirable. Hands-on experience with biochemical and biophysical techniques for protein characterization, including chromatography (SEC, IEX, RP), viscosity, gel electrophoresis (CE-SDS, MCE, cIEF, iCE), particle size (DLS, HIAC, MFI), spectroscopy (UV-Vis, CD, AUC, fluorescence), and thermostability characterization (DSC, DSF) is desirable.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)