Senior Scientist, Preclinical Development (Onsite)

About the role

The Sterile Product Development (SPD) group develops non-oral dosage forms (injections, implants, inhaled, ocular) for biologics, mixed modalities, vaccines, and small molecules from preclinical toxicology studies through commercialization. The team ensures robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization to enable scalable processes without compromising stability, safety, efficacy, and delivery. Development leverages smart experimental design, cutting-edge analytical tools, and predictive approaches to inform molecule, formulation, and process selection, translating preclinical candidates into non-oral drug products.

Responsibilities

• Design and develop sterile products for biologics (monoclonal antibodies, fusion proteins, antibody-drug conjugates) for injectable and ophthalmic routes of administration (lab-based, on-site role).
• Support product development of early and late-stage assets while building mechanistic understanding of degradation and process design space.
• Screen and develop robust drug product compositions, develop scalable processes, and define primary packaging.
• Coordinate GXP manufacturing activities and compatibility characterization to enable drug product processing and dosage administration in toxicology and clinical studies.
• Build deep fundamental knowledge around the drug product and document experimental findings and conclusions in formulation development reports and regulatory filings.
• Actively participate in and lead formulation development teams, interfacing and collaborating with key stakeholders to drive project milestones.

Requirements

Education

Master’s degree with four years of experience or Ph.D. in Chemical/Biochemical/Biomedical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related field.

Required Experience and Skills

• Protein stability
• Protein-protein/protein-excipient interaction
• Biologic molecule design
• Formulation screening
• Characterization
• Process development or process modeling
• Stability predictive modeling
• Basic understanding of sterile product development

Preferred Coursework

• Biochemistry, protein design, pharmaceutics, physiology, pharmacokinetics, protein sciences, chemical kinetics, transport phenomena, physical pharmacy

Additional Desired Experience

• Biologics formulation design/process development
• Alternative processing approaches
• Definition of critical attributes for process scale-up
• Analytical development and Chemistry, Manufacturing and Control (CMC) filing for sterile dosage forms including ocular dosage forms, peptide therapeutics, and non-conventional drug delivery technologies (e.g., emulsions, suspensions, injectable depot)

Skills

Required Skills

• Biochemistry
• Bioconjugation
• Biologics
• Biomolecular Chemistry
• Bioprocessing
• Clinical Development
• Clinical Research
• Cross-Functional Teamwork
• Design of Experiments (DOE)
• Drug Delivery Technology
• Drug Formulations
• Medicinal Chemistry
• Molecular Biology Techniques
• Preclinical Research
• Process Optimization

Preferred Skills

Not specified beyond the required skills listed above.

Pay

Base salary range for the primary location (USA – New Jersey – Rahway): $117,000.00 – $184,200.00. Actual placement within the range depends on education, qualifications, certifications, experience, skills, geographic location, government requirements, and business needs. The successful candidate is eligible for annual bonus and long-term incentive, if applicable. Additional locations (e.g., San Francisco, Los Angeles) may have different compensation guidelines.

Benefits

Comprehensive benefits package including medical, dental, and vision healthcare and other insurance benefits (for employee and family), retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days. More details available at https://jobs.merck.com/us/en/compensation-and-benefits.

Schedule and Location

• Primary location: USA – New Jersey – Rahway
• Additional location(s): San Francisco, Los Angeles (compensation may vary)
• Travel requirements: 10%
• Flexible work arrangements: Not applicable
• Shift: Not indicated
• Relocation: Domestic
• Visa sponsorship: Yes
• Valid driving license: No
• Hazardous materials: Biohazardous materials

Requisition ID: R422549. Job posting effective until 11:59:59 PM on 10/25/2026 (the day before the listed end date of 10/26/2026).