Stellenbeschreibung
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.
A Typical Day in the Role Might Look Like:
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.
This Role Might Be For You if You:
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
Possess strong ability to prioritize and manage multiple tasks effectively.
Are highly organized, detail-oriented, self-motivated, effective team player.
Have 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 are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$80,300.00 - $131,100.00