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Senior Scientist, Analytical Development and Quality Control - Early Phase (Biopharma)

162Β 000 - 186Β 000$
Π€ΠΎΡ€ΠΌΠ°Ρ‚ Ρ€Π°Π±ΠΎΡ‚Ρ‹
onsite
Π’ΠΈΠΏ Ρ€Π°Π±ΠΎΡ‚Ρ‹
fulltime
Π“Ρ€Π΅ΠΉΠ΄
senior
Английский
b2
Π‘Ρ‚Ρ€Π°Π½Π°
US
Вакансия ΠΈΠ· списка Hirify.GlobalВакансия ΠΈΠ· Hirify Global, списка ΠΌΠ΅ΠΆΠ΄ΡƒΠ½Π°Ρ€ΠΎΠ΄Π½Ρ‹Ρ… tech-ΠΊΠΎΠΌΠΏΠ°Π½ΠΈΠΉ
Для мэтча ΠΈ ΠΎΡ‚ΠΊΠ»ΠΈΠΊΠ° Π½ΡƒΠΆΠ΅Π½ Plus

ΠœΡΡ‚Ρ‡ & Π‘ΠΎΠΏΡ€ΠΎΠ²ΠΎΠ΄

Для мэтча с этой вакансиСй Π½ΡƒΠΆΠ΅Π½ Plus

ОписаниС вакансии

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TL;DR
Senior Scientist, Analytical Development and Quality Control - Early Phase (Biopharma): Leading drug product analytical method development, validation, stability programs, and lifecycle management for oncology and inflammation and immunology programs with an accent on amorphous solid dispersions, lipid-based formulations, and regulatory submissions. Focus on overseeing CDMO and CRO analytical activities, analyzing stability data, supporting PPQ and commercialization, and authoring technical and regulatory documentation.

Location: Onsite at Nurix headquarters in Brisbane, California, United States; travel up to 5% may be required.

Salary: $162,000–$186,000 per year

Company

hirify.global is a clinical-stage biopharmaceutical company developing targeted protein degradation medicines for cancer and inflammatory diseases through an AI-integrated discovery engine.

What you will do

  • Lead analytical method development, validation, and lifecycle management for drug product formulations, including amorphous solid dispersions and lipid-based systems.
  • Design and oversee development, registration batch, and commercial stability programs, including protocols, trend analysis, retest periods, and shelf-life assessments.
  • Provide technical oversight of analytical development, validation, and QC testing performed by CDMOs and contract testing laboratories.
  • Support PPQ, commercialization, commercial QC, late-phase technology transfer, and analytical control strategies.
  • Author and review analytical development reports, specifications, validation and stability documents, certificates of analysis, and storage statements.
  • Contribute to investigations, root-cause analysis, CAPAs, regulatory submissions, health-authority responses, data integrity, and inspection readiness.

Requirements

  • Advanced degree in chemistry, pharmaceutics, or a related discipline.
  • BS/MS with 14+ years or PhD with 8+ years of industrial CMC experience.
  • Strong experience in drug product analytical development and validation, including chromatographic and dissolution methods.
  • Experience with amorphous solid dispersions and/or lipid-based formulations, CDMO oversight, and contract testing laboratories.
  • Experience supporting IND, IMPD, NDA, and global regulatory filings.
  • Fluency with ICH guidelines, cGMP requirements, pharmacopeial chapters, technical writing, and cross-functional collaboration.

Culture & Benefits

  • Work in multidisciplinary teams spanning Chemical Development, Pharmaceutical Development, Regulatory, Quality, Preclinical, Supply Chain, Medicinal Chemistry, and DMPK.
  • Operate in a fast-paced environment while managing multiple priorities.
  • Follow cGMP requirements and internal SOPs.
  • Maintain organized analytical documentation and data for traceability, data integrity, and inspection readiness.

Π‘ΡƒΠ΄ΡŒΡ‚Π΅ остороТны: Ссли Ρ€Π°Π±ΠΎΡ‚ΠΎΠ΄Π°Ρ‚Π΅Π»ΡŒ просит Π²ΠΎΠΉΡ‚ΠΈ Π² ΠΈΡ… систСму, ΠΈΡΠΏΠΎΠ»ΡŒΠ·ΡƒΡ iCloud/Google, ΠΏΡ€ΠΈΡΠ»Π°Ρ‚ΡŒ ΠΊΠΎΠ΄/ΠΏΠ°Ρ€ΠΎΠ»ΡŒ, Π·Π°ΠΏΡƒΡΡ‚ΠΈΡ‚ΡŒ ΠΊΠΎΠ΄/ПО, Π½Π΅ Π΄Π΅Π»Π°ΠΉΡ‚Π΅ этого - это мошСнники. ΠžΠ±ΡΠ·Π°Ρ‚Π΅Π»ΡŒΠ½ΠΎ ΠΆΠΌΠΈΡ‚Π΅ "ΠŸΠΎΠΆΠ°Π»ΠΎΠ²Π°Ρ‚ΡŒΡΡ" ΠΈΠ»ΠΈ ΠΏΠΈΡˆΠΈΡ‚Π΅ Π² ΠΏΠΎΠ΄Π΄Π΅Ρ€ΠΆΠΊΡƒ. ΠŸΠΎΠ΄Ρ€ΠΎΠ±Π½Π΅Π΅ Π² Π³Π°ΠΉΠ΄Π΅ β†’