Senior Scientist, Preclinical Development (Onsite)

MSD•Rahway, NJ

3d•$117,000 - $184,200•Onsite

About The Position

The Sterile Product Development 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 group uses fundamental understanding and characterization, experimental design, analytical tools and predictive approaches to select robust product compositions, packaging, devices and processes that can scale without compromising stability, safety, efficacy or delivery. This lab-based, onsite role designs and develops sterile injectable and ophthalmic products for biologics, including monoclonal antibodies, fusion proteins and antibody-drug conjugates. The scientist supports early- and late-stage assets and develops mechanistic understanding of degradation and process design spaces. The role includes developing product composition and scalable processes, defining primary packaging, coordinating GXP manufacturing and compatibility characterization, and enabling drug-product processing and administration in toxicology and clinical studies. The scientist builds fundamental knowledge of drug products, documents findings and conclusions in formulation development reports and regulatory filings, and participates in and leads formulation development teams while collaborating with stakeholders to advance project milestones.

Requirements

Master’s degree with four years of experience, or a Ph.D., in Chemical, Biochemical or Biomedical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical 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.
Basic understanding of sterile product development.
Initiative, motivation to excel, a strong technical background, and 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 in biologics formulation design and process development.
Knowledge of alternative processing approaches and defining critical attributes for process scale-up.
Experience in analytical development and Chemistry, Manufacturing and Control filings for sterile dosage forms, including ocular dosage forms.
Experience with peptide therapeutics and non-conventional drug-delivery technologies, such as emulsions, suspensions and injectable depots.

Responsibilities

Design and develop sterile injectable and ophthalmic drug products for biologics.
Support product development for early- and late-stage assets.
Develop mechanistic understanding of product degradation and process design spaces.
Screen and develop robust drug-product compositions.
Develop scalable processes and define primary packaging.
Coordinate GXP manufacturing activities and appropriate compatibility characterization.
Enable drug-product processing and dosage administration in toxicology and clinical studies.
Build fundamental knowledge of drug products and document findings and conclusions in formulation development reports and regulatory filings.
Participate in and lead formulation development teams.
Interface and collaborate with stakeholders to drive project milestones.