Senior Scientist, Preclinical Development (Onsite)

MSD•Rahway, NJ

3d•$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 studies through commercialization. The group applies fundamental understanding and characterization to select robust compositions, primary packaging and devices, and scalable processes that maintain stability, safety, efficacy and delivery. It also uses experimental design, analytical tools and predictive approaches to guide molecule, formulation and process selection. 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 space. The role includes developing drug product composition and scalable processes, defining primary packaging, coordinating GXP manufacturing and compatibility characterization for toxicology and clinical studies, and documenting findings in development reports and regulatory filings. The scientist actively participates in and leads formulation development teams, collaborates with stakeholders, and drives 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; or basic sterile product development.
Strong technical background.
Excellent communication and interpersonal skills.
Initiative and motivation to excel.

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 or process development.
Experience with alternative processing approaches.
Experience 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 or non-conventional drug delivery technologies, such as emulsions, suspensions or injectable depots.

Responsibilities

Design and develop sterile biologic drug products 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.
Develop scalable processes and define primary packaging.
Coordinate GXP manufacturing activities and 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.
Participate actively in and lead formulation development teams.
Interface and collaborate with key stakeholders to drive project milestones.