Sr. Associate Scientist, Drug Product Development and Technology (1 of 3)
Regeneron
12 hours ago
On-site
Tarrytown, NY
Operations
Job Duties:
- Design and independently execute phase-appropriate formulation development studies (formulation screening, stability and compatibility studies) to support drug product development for early and late-stage programs.
- Conduct pre-formulation studies for monoclonal antibodies, bioconjugates, and peptides to identify critical quality attributes (CQAs) for formulation and drug product development.
- Develop analytical methods for drug products (primary focus on peptides; supporting focus on antibody–drug conjugates, siRNA, monoclonal antibodies, and bispecific antibodies).
- Develop and qualify analytical methods for CQAs to support formulation development, DP process development, and stability testing for preclinical and clinical programs.
- Characterize drug product formulations to support process development and manufacturing of clinical drug substances and drug products.
- Document findings and lab records in an electronic laboratory notebook.
- Contribute to formulation development technical reports to provide insights into process development and manufacturing.
- Participate in meetings and present study results in cross-functional/department meetings.
- Author protocols and internal technical documents; support regulatory filings.
- Support general laboratory and instrument maintenance.
Job Requirements:
- Take direction and guidance for data-driven decision making, priority setting, and technical problem solving.
- Generate and organize data figures and data tables clearly and insightfully.
- Communicate critical data to supervisor and team in a timely manner.
- Strong ability to prioritize and manage multiple tasks.
- Highly organized, detail-oriented, self-motivated, effective team player.
- Excellent oral and written communication skills.
Qualifications:
- B.S. or M.S. in Pharmaceutical Sciences, Chemistry, Biochemistry, Biophysics, Biomedical Engineering, Analytical Chemistry, Chemical Engineering, or related discipline.
- At least 3 years of industrial experience.
- Ability to design and execute experiments; interpret, document, and communicate results with minimal supervision.
- Desirable: protein/peptide chemistry; biophysical/biochemical protein characterization; bioanalytical method development; biomolecule product development.
- Desirable hands-on techniques: chromatography (SEC, IEX, RP), viscosity, gel electrophoresis (CE-SDS, MCE, cIEF, iCE), particle size (DLS, HIAC, MFI), spectroscopy (UV-Vis, CD, AUC, fluorescence), thermostability (DSC, DSF).
Application:
- Apply now to take your first step towards living the Regeneron Way.
Benefits:
- In the U.S., benefits may include health and wellness programs (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.
Compensation:
- Salary range (annually): $80,300.00 - $131,100.00.
- Design and independently execute phase-appropriate formulation development studies (formulation screening, stability and compatibility studies) to support drug product development for early and late-stage programs.
- Conduct pre-formulation studies for monoclonal antibodies, bioconjugates, and peptides to identify critical quality attributes (CQAs) for formulation and drug product development.
- Develop analytical methods for drug products (primary focus on peptides; supporting focus on antibody–drug conjugates, siRNA, monoclonal antibodies, and bispecific antibodies).
- Develop and qualify analytical methods for CQAs to support formulation development, DP process development, and stability testing for preclinical and clinical programs.
- Characterize drug product formulations to support process development and manufacturing of clinical drug substances and drug products.
- Document findings and lab records in an electronic laboratory notebook.
- Contribute to formulation development technical reports to provide insights into process development and manufacturing.
- Participate in meetings and present study results in cross-functional/department meetings.
- Author protocols and internal technical documents; support regulatory filings.
- Support general laboratory and instrument maintenance.
Job Requirements:
- Take direction and guidance for data-driven decision making, priority setting, and technical problem solving.
- Generate and organize data figures and data tables clearly and insightfully.
- Communicate critical data to supervisor and team in a timely manner.
- Strong ability to prioritize and manage multiple tasks.
- Highly organized, detail-oriented, self-motivated, effective team player.
- Excellent oral and written communication skills.
Qualifications:
- B.S. or M.S. in Pharmaceutical Sciences, Chemistry, Biochemistry, Biophysics, Biomedical Engineering, Analytical Chemistry, Chemical Engineering, or related discipline.
- At least 3 years of industrial experience.
- Ability to design and execute experiments; interpret, document, and communicate results with minimal supervision.
- Desirable: protein/peptide chemistry; biophysical/biochemical protein characterization; bioanalytical method development; biomolecule product development.
- Desirable hands-on techniques: chromatography (SEC, IEX, RP), viscosity, gel electrophoresis (CE-SDS, MCE, cIEF, iCE), particle size (DLS, HIAC, MFI), spectroscopy (UV-Vis, CD, AUC, fluorescence), thermostability (DSC, DSF).
Application:
- Apply now to take your first step towards living the Regeneron Way.
Benefits:
- In the U.S., benefits may include health and wellness programs (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.
Compensation:
- Salary range (annually): $80,300.00 - $131,100.00.