Senior Scientist, Preclinical Development (Onsite)

Job Description

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.

Primary Responsibilities

This is a lab based (on-site) role responsible for 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

Take initiative, motivated to excel, have a strong technical background, have excellent communication and interpersonal skills

Education Requirements

Masters with four years or Ph.D. Degree in Chemical/ Biochemical/ Biomedical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or related field

Experience and Skills

Required

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

Preferred

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)

#eligibleforERP

#PRD

Required Skills:

Biochemistry, Bioconjugation, Biologics, Biomolecular Chemistry, Bioprocessing, Clinical Development, Clinical Research, Cross-Functional Teamwork, Design of Experiments (DOE), Drug Delivery Technology, Drug Formulations, Medicinal Chemistry, Molecular Biology Techniques, Preclinical Research, Process Optimization

Preferred Skills:

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