Senior Scientist, Sterile Product Development (On-site)

About the role

The Sterile Product Development (SPD) group is responsible for developing non-oral dosage forms (injections, implants, inhaled, ocular) for biologics, mixed modalities, vaccines, and small molecules from preclinical toxicology studies to commercialization. Our development teams ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization, ensuring the process is scalable without compromising stability, safety, efficacy, and delivery. During development, we leverage smart experimental design, cutting-edge analytical tools, and predictive approaches to inform molecule, formulation, and process selection. The team enables the translation of 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.
• Support product development of both early and late-stage assets while developing a mechanistic understanding of degradation and process design space.
• Conduct key studies including screening and developing robust drug product composition, scalable processes, and defining primary packaging.
• Coordinate good practice (GXP) manufacture activities and appropriate compatibility characterization to enable processing of drug product 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.
• Demonstrate initiative, strong technical background, excellent communication, and interpersonal skills.

Requirements

Masters with four years or Ph.D. Degree (or expected graduation in 2026) in Chemical/Biochemical/Biomedical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related field.

Skills

• 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 phenomenon, physical pharmacy.
• Preferred 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).
• Required Skills: Biologics, Bioprocessing, Characterization Techniques, Data Analysis, Drug Delivery, Drug Formulations, Drug Product Development, Molecular Biology Techniques, Pharmaceutical Process Development, Pharmaceutical Sciences, Product Formulation, Protein Biochemistry, Protein Purifications, Stability Studies, Sterile Products.

Pay

The salary range for this role is $117,000.00 - $184,200.00. An employee’s position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits, including:

• Medical, dental, vision healthcare, and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays, vacation, and compassionate and sick days

More information about benefits is available at Merck Compensation and Benefits.

Schedule

• Employee Status: Regular
• Relocation: Domestic
• Travel Requirements: 10%
• Shift: 1st - Day
• Flexible Work Arrangements: Not Applicable
• VISA Sponsorship: Available

Job Posting End Date: 09/8/2026