Sr. Scientist, Preclinical Development - Biologics Product Development

MSD • Rahway, NJ

2d • Hybrid

About The Position

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 such that 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. In summary, our team enables the translation of preclinical candidates into non-oral drug products.

Requirements

• Take initiative, motivated to excel, have a strong technical background, have excellent communication and interpersonal skills
• Master's, with four years or Ph.D. Degree in Chemical/Biochemical/Biomedical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or related field
• Experience and/or knowledge in one or more of the following: 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.

Nice To Haves

• Course work in biochemistry, protein design, pharmaceutics, physiology, pharmacokinetics, protein sciences, chemical kinetics, Transport phenomenon, physical pharmacy is highly desirable.
• Biologics formulation design/process development, alternative processing approaches, definition of critical attributes for process scale-up, analytical development and Chemistry, Manufacturing and Control filing for sterile dosage forms including ocular dosage forms, peptide therapeutics, and non-conventional drug delivery technologies (e.g. emulsions, suspensions, injectable depot).

Responsibilities

• Designing and developing sterile products for biologics (monoclonal antibodies, fusion proteins, antibody-drug conjugates) drugs for injectable and ophthalmic routes of administration.
• Support product development of both early and late-stage assets while developing mechanistic understanding of the degradation and process design space.
• Key studies include screening and developing robust drug product composition, developing scalable process 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 study.
• Build deep fundamental knowledge around the drug product and document experimental findings and conclusions in formulation development reports and regulatory filings.
• Active participation and leadership on formulation development teams and interfacing and collaborating with key stakeholders to drive project milestones.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Senior