Sr. Scientist / Principal Scientist – Product Development – Early Stage
| Company | Neurocrine Biosciences |
|---|---|
| Location | San Diego, CA, USA |
| Salary | $128200 – $185900 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- BS/BA degree in Chemistry, Biochemistry, Chemical Engineering, or related field and 12+ years of pharmaceutical industry experience, specifically in a chemistry, analytical, or characterization laboratory setting. Experience with the following instrumentation and techniques is required; HPLC, Solubility Analysis, DSC, TGA, PXRD, Particle-Size Analysis, GVS, PLM, T3, and SEM. Experience managing preclinical/clinical Contract Research Organizations and Contract Manufacturing Organizations. Experience preparing INDs & NDAs OR
- MS/MA degree in Chemistry, Biochemistry, Chemical Engineering, or related field and 10+ years of similar experience noted above OR
- PhD in Chemistry, Biochemistry, Chemical Engineering, or related field and 4+ years of similar experience noted above; may include postdoc experience
- Working knowledge in the following instrument/testing: HPLC-UV, LC-MS, SEC-MALS, viscosity, osmolality, dynamic light scattering (DLS), capillary isoelectric focusing (cIEF), subvisible particulate matter, density, injectability, etc.
- Experience with antibody *and* peptide development is a plus
- Technical writing: protocols, SOPs, and reports
- Experience working at or with Contract Development and Manufacturing Organizations (CDMOs)
- Proficient in all formulation-enabling aspects of characterization for peptide and other protein-based therapeutics
- Experience in peptide chemistry and knowledge of structural predictive degradation pathways is a positive differentiator for this role
- Excellent interpersonal skills with strong oral and written communication abilities
- Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas
- Understanding of compendial methods of sterile drug product manufacturing (e.g, sterility, endotoxin, sub-visible particles, etc.)
- Exhibits leadership skill and ability, typically leads junior levels and/or indirect teams
- Excellent computer skills, communications, problem-solving, analytical thinking skills
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
Responsibilities
- Design and execute developability assessments of novel peptides/protein-based therapeutics (and salt forms thereof) to inform selection of development compounds with drug-like properties
- Design, develop, characterize and optimize various drug product formulations in support of preclinical and early stage clinical studies
- Develop phase appropriate analytical methods to support evaluation of physiochemical properties and stability of prototype peptide/protein formulations (e.g., HPLC-based assay/purity methods, SEC-MALS, DLS, isoelectric point, etc.)
- Investigate and implement new technologies utilized to characterize peptide/protein-based therapeutics to expand capabilities and platforms within the Product Development department
- Actively collaborate and share expertise with R&D partners
- Effectively communicate scientific rationale, results and interpretations at project, group and department-level meetings
- Maintain meticulous and up-to-date laboratory records and generate study reports (e.g, summary of developability studies, formulation development summaries, etc.)
- Support other activities of drug product development programs as needed.
Preferred Qualifications
- Experience with antibody *and* peptide development is a plus
- Technical writing: protocols, SOPs, and reports
- Experience working at or with Contract Development and Manufacturing Organizations (CDMOs)
- Experience in peptide chemistry and knowledge of structural predictive degradation pathways is a positive differentiator for this role.