Senior Scientist, Sterile Product Development (On-site)
Merck
Primary Responsibilities
- Design and develop sterile products for biologics (monoclonal antibodies, fusion proteins, antibody-drug conjugates) for injectable and ophthalmic routes.
- Support product development for early and late-stage assets; develop mechanistic understanding of degradation and the process design space.
- Screen/develop robust drug product compositions; develop scalable processes and define primary packaging.
- Coordinate GxP manufacture activities and perform compatibility characterization for toxicology and clinical studies.
- Document experimental findings in formulation development reports and regulatory filings.
- Participate in and lead formulation development teams; interface with stakeholders to drive milestones.
Education Requirements
- Masterβs (4 years) or Ph.D. (or expected graduation 2026) in Chemical/Biochemical/Biomedical Engineering, Pharmaceutics, Pharmaceutical Chemistry/Sciences, Chemistry, Biochemistry, or related field.
Required Experience/Skills
- Protein stability; protein-protein/protein-excipient interactions; biologic molecule design; formulation screening; characterization; process development/modeling; stability predictive modeling; basic sterile product development.
Preferred
- Course work in biochemistry/protein design/pharmaceutics/physiology/pharmacokinetics/protein sciences/chemical kinetics/transport phenomenon/physical pharmacy.
- Experience in biologics formulation and process development; critical attribute definition for scale-up; analytical development; CMC (including ocular dosage forms); peptide therapeutics; non-conventional drug delivery (e.g., emulsions, suspensions, injectable depot).
Required Skills
- Biologics, bioprocessing, characterization techniques, data analysis, drug delivery/formulations/product development, molecular biology techniques, pharmaceutical process sciences, protein biochemistry/purifications, stability studies, sterile products.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.