Senior Scientist, Preclinical Development (Onsite)

MSD • Rahway, NJ

2d • $117,000 - $184,200 • Onsite

About The Position

The Sterile Product Development (SPD) group develops non-oral dosage forms—including injections, implants, inhaled and ocular products—for biologics, mixed modalities, vaccines and small molecules, from preclinical toxicology through commercialization. The team selects robust compositions, primary packaging or devices, and scalable processes using fundamental understanding, characterization, experimental design, analytical tools and predictive approaches. Its work helps translate preclinical candidates into non-oral drug products.

This lab-based, onsite role designs and develops sterile products for biologics, including monoclonal antibodies, fusion proteins and antibody-drug conjugates, for injectable and ophthalmic administration. The scientist supports early- and late-stage assets and develops mechanistic understanding of degradation and process design. The role includes formulation and process development, compatibility characterization, support for GXP manufacturing, documentation for development reports and regulatory filings, and active leadership and collaboration on formulation development teams. The primary location is Rahway, New Jersey. The position involves 10% travel and biohazardous materials.

Requirements

• Master’s degree with four years of experience, or a Ph.D., in Chemical, Biochemical or Biomedical Engineering; Pharmaceutics; Pharmaceutical Chemistry or Sciences; Chemistry; Biochemistry; or a related field.
• Experience and/or knowledge in one or more of the following: protein stability; protein-protein or protein-excipient interactions; biologic molecule design; formulation screening; characterization; process development or process modeling; stability predictive modeling; or sterile product development.
• Strong technical background, initiative and motivation to excel, with excellent communication and interpersonal skills.

Nice To Haves

• Coursework in biochemistry, protein design, pharmaceutics, physiology, pharmacokinetics, protein sciences, chemical kinetics, transport phenomena or physical pharmacy.
• Experience with biologics formulation design or process development, alternative processing approaches, defining critical attributes for process scale-up, analytical development, or Chemistry, Manufacturing and Control filings for sterile dosage forms, including ocular dosage forms.
• Experience with peptide therapeutics or non-conventional drug delivery technologies such as emulsions, suspensions or injectable depots.
• Skills in biochemistry, bioconjugation, biologics, biomolecular chemistry, bioprocessing, clinical development or research, cross-functional teamwork, design of experiments, drug delivery technology, drug formulations, medicinal chemistry, molecular biology techniques, preclinical research or process optimization.

Responsibilities

• Design and develop sterile drug products for biologics intended for injectable and ophthalmic routes of administration.
• Support product development for early- and late-stage assets and develop mechanistic understanding of degradation and process design space.
• Screen and develop robust drug product compositions, scalable processes and primary packaging.
• Coordinate GXP manufacturing activities and appropriate compatibility characterization to support drug product processing and dosage administration in toxicology and clinical studies.
• Build fundamental knowledge of drug products and document experimental findings and conclusions in formulation development reports and regulatory filings.
• Actively participate in and provide leadership on formulation development teams, collaborating with key stakeholders to drive project milestones.

Benefits

• Medical, dental and vision healthcare and other insurance benefits for employees and families.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days and sick days.
• Annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree