Prin. Scientist, Analytical R&D
Merck
5 hours ago
Remote friendly (Rahway, NJ)
United States
Other
Responsibilities:
- Lead and/or contribute to projects in a biotherapeutics pipeline by developing and implementing biophysical and particle characterization tools.
- Build mechanistic understanding of the interplay between formulation composition, stability, device, and process to ensure robustness and quality of drug substances and drug products.
- Mentor team members in designing experiments, interpreting data, and delivering results on time.
- Use scientific expertise to develop creative solutions to challenging analytical problems.
- Author technical reports and regulatory documents; present technical data.
- Conduct independent research; publish findings; present at scientific conferences; engage with external scientific societies/organizations.
- Manage projects.
Education/Qualifications:
- Ph.D. in Biophysics, Biochemistry, Chemistry, Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or related discipline with a minimum of 8 years of relevant industry experience.
- OR M.S. with a minimum of 10 years of relevant industry experience.
Required Experience and Skills:
- Extensive experience analyzing biologics, protein/peptide stability, and protein-protein interactions.
- Extensive experience with subvisible particle characterization methodologies; develop and execute analytical control strategies.
- Strong background developing and implementing biophysical characterization assays (e.g., CD, IR, DSC, AUC).
- Understanding of protein aggregation mechanisms and how they link to analytical methodologies.
- Mentoring ability (matrix management and peer-to-peer coaching).
- Initiative, creativity, and innovative problem solving.
- Ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.
- Excellent oral and written communication; can work independently and cross-functionally.
- Experience authoring/reviewing internal technical reports, IND/BLA regulatory filing sections, and external scientific publications.
- Established scientific reputation and external influence (publications, patents, presentations, and involvement/leadership in cross-company working groups/consortia).
Desired Experience and Skills:
- Experience characterizing biologics modalities (mAb, antibody-drug conjugates, fusion proteins, peptides).
- Experience characterizing lyophilized protein formulations.
- Experience with extraneous matter (EM) investigations for particle identification.
- Experience/knowledge in formulation development and relevant analytical method development.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.
Requisition ID: R393635
- Lead and/or contribute to projects in a biotherapeutics pipeline by developing and implementing biophysical and particle characterization tools.
- Build mechanistic understanding of the interplay between formulation composition, stability, device, and process to ensure robustness and quality of drug substances and drug products.
- Mentor team members in designing experiments, interpreting data, and delivering results on time.
- Use scientific expertise to develop creative solutions to challenging analytical problems.
- Author technical reports and regulatory documents; present technical data.
- Conduct independent research; publish findings; present at scientific conferences; engage with external scientific societies/organizations.
- Manage projects.
Education/Qualifications:
- Ph.D. in Biophysics, Biochemistry, Chemistry, Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or related discipline with a minimum of 8 years of relevant industry experience.
- OR M.S. with a minimum of 10 years of relevant industry experience.
Required Experience and Skills:
- Extensive experience analyzing biologics, protein/peptide stability, and protein-protein interactions.
- Extensive experience with subvisible particle characterization methodologies; develop and execute analytical control strategies.
- Strong background developing and implementing biophysical characterization assays (e.g., CD, IR, DSC, AUC).
- Understanding of protein aggregation mechanisms and how they link to analytical methodologies.
- Mentoring ability (matrix management and peer-to-peer coaching).
- Initiative, creativity, and innovative problem solving.
- Ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.
- Excellent oral and written communication; can work independently and cross-functionally.
- Experience authoring/reviewing internal technical reports, IND/BLA regulatory filing sections, and external scientific publications.
- Established scientific reputation and external influence (publications, patents, presentations, and involvement/leadership in cross-company working groups/consortia).
Desired Experience and Skills:
- Experience characterizing biologics modalities (mAb, antibody-drug conjugates, fusion proteins, peptides).
- Experience characterizing lyophilized protein formulations.
- Experience with extraneous matter (EM) investigations for particle identification.
- Experience/knowledge in formulation development and relevant analytical method development.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.
Requisition ID: R393635