Pharmaceutical Engineer II/ Sr Pharmaceutical Engineer

Location
San Francisco, CA
Posted
Jan 24, 2022
Ref
5858079002
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Company

Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix’s extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels.

Nurix’s wholly owned pipeline comprises targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California.


Job Summary:

Nurix is looking for a formulation scientist or pharmaceutical engineer in the drug product division of CMC to provide scientific, technical, and strategic leadership related to development of oral solid dosages (OSD) of small molecules.

 Duties/Responsibilities:

  • Perform and oversee formulation development and process optimization for clinical studies and commercialization.
  • Oversee outsourcing of analysis, development, manufacture, tech transfer and scale-up of OSD products.
  • Oversee process robustness determination and validation for small molecule oral drugs.
  • Determine critical quality attributes (CQA) for manufacturability and effect on safety/efficacy related CQA.
  • Build strategy and coauthor regulatory filings at all stages of development.
  • Work closely with cross functional teams to ensure on-time delivery and rapid development of clinical phase products to registration: analytical chemistry, chemical development, program management, supply chain, clinical pharmacology, and clinical sciences.
  • Travel as needed to transfer processes and observe manufacturing.

Required Skills/Abilities:

  • Experienced in formulation, process development, manufacture, and scale-up of oral solid dosage forms of small molecules.
  • Knowledge and familiarity with manufacturing techniques and equipment: milling, blending, roller compaction, wet granulation, fluid bed processing, hot melt extrusion, spray drying, encapsulation, compression, and coating.
  • Experience in safe handling of human therapeutic agents, including potent compounds.
  • Knowledge of analytical techniques: Dissolution, Disintegration, material characteristics (surface area, particle size distribution, density, solid fraction, hardness, friability)
  • Additional analytical experience a plus, such as: HPLC/UPLC, XRD, Raman, FTIR etc
  • Experience in cGMP environment and knowledge of 21CFR.
  • Working knowledge of Regulatory Guidances from FDA, EMA, and ICH.
  • Experience with regulatory filings.
  • Proficient with Microsoft 365
  • Experience in large data sets, data presentation and modelling a plus. (eg R, python, JMP®, Minitab®, Spotfire®, Gastroplus®)

 Education and Experience:

PhD in physical sciences, engineering or pharmaceutical sciences with 3+ years of industrial experience, Bachelor or Master degree in physical sciences, engineering or pharmaceutical sciences with 8+ years of industrial experience


Physical Requirements:

Ability to travel and wear appropriate PPE for site visits.

Prolonged periods of sitting at a desk and working on a computer may be required.