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8 дней назад

Process Development Senior Scientist (ADC Biologics)

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Process Development Senior Scientist (ADC Biologics): Developing commercial formulations and fill/finish processes for late-stage biologics, with an accent on ADC formulation, stability, analytical characterization, and manufacturability. Focus on integrating formulation and process data, applying AI/ML for predictive modeling, and solving technical challenges across scale-up, technology transfer, and manufacturing campaigns.

Location: Thousand Oaks, California, United States; onsite work supporting laboratory formulation, sterile filling, and manufacturing activities.

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

  • Participate in drug product commercialization teams for pipeline development and lifecycle management of commercial products.
  • Design, execute, and document formulation and process development studies for liquid and lyophilized biologics.
  • Develop ADC drug product formulations, handling procedures, and lab-scale sterile filling processes.
  • Build process understanding across unit operations, evaluate stability and in-use compatibility, and support scalable manufacturing.
  • Apply statistical analytics, AI, machine learning, and data science to predictive modeling and technical decision-making.
  • Prepare technical, regulatory, risk assessment, control-strategy, and technology-transfer documentation; support CMO/CDMO transfers and manufacturing troubleshooting.

Requirements

  • Doctorate degree, or a master’s degree with 2 years of scientific experience, or a bachelor’s degree with 4 years of scientific experience.
  • Experience in biologics formulation development, stability testing, and fill/finish operations; direct ADC drug product formulation experience is strongly preferred.
  • Understanding of ADC development, including linker-payload stability, drug-to-antibody ratio, degradation pathways, quality attributes, and comparability.
  • Experience with analytical and biophysical techniques such as UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, and subvisible particle analysis.
  • Ability to integrate formulation, stability, and analytical data and contribute to regulatory submissions such as CTAs and BLAs.
  • Strong scientific communication and cross-functional collaboration skills.

Nice to have

  • PhD in Pharmaceutics, Biotechnology, Biochemistry, or a related field.
  • 2–4 years of postdoctoral or industry experience.

Culture & Benefits

  • Collaborative, innovative, science-based working environment.
  • Health, dental, vision, life, disability, and flexible spending benefits.
  • Retirement and savings plan with company contributions.
  • Annual bonus program and stock-based long-term incentives.
  • Paid time off and career development opportunities.

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