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8 дней назад

Process Development Senior Principal 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 Principal Scientist (ADC Biologics): Developing and commercializing biologic drug product formulations and fill/finish processes with an accent on ADC formulation, linker-payload stability, analytical characterization, and technology transfer. Focus on applying AI/ML and data science, leading matrixed drug product teams, and solving formulation, manufacturing, and regulatory challenges for late-stage biologics.

Location: Thousand Oaks, California, United States; onsite role with up to 10% domestic and international travel.

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

  • Lead laboratory studies for drug product design, formulation, process development, documentation, and technology transfer.
  • Develop and characterize liquid and lyophilized biologic formulations, with emphasis on ADC drug products and lab-scale sterile filling.
  • Integrate formulation, analytical, stability, and process data to guide product design and commercialization.
  • Lead internal and external technology transfers, process-fit assessments, CMO/CDMO collaboration, and manufacturing troubleshooting.
  • Apply AI, machine learning, and data science to predictive modeling, workflow acceleration, and decision-making.
  • Lead matrixed drug product teams and manage engineers and scientists supporting commercialization and lifecycle management.

Requirements

  • PhD, PharmD, or MD plus 2 years of scientific experience; or a master’s degree plus 5 years; or a bachelor’s degree plus 7 years.
  • Experience in pharmaceutical or biotechnology development, including formulation, fill/finish process development, process characterization, technology transfer, and design of experiments.
  • Direct ADC drug product formulation experience is strongly preferred, including linker-payload stability, drug-to-antibody ratio, degradation pathways, quality attributes, and comparability.
  • Strong knowledge of biologic formulation, stability testing, aseptic processing, manufacturing, analytical and biophysical techniques, and regulatory authoring.
  • Experience with programming and data tools such as Python, R, MATLAB, SQL, Tableau, Spotfire, or D3, plus statistical software such as SAS, JMP, or Minitab.
  • Ability to lead global multifunctional teams, solve complex problems, influence stakeholders, and learn new technologies rapidly.

Culture & Benefits

  • Collaborative, innovative, science-based environment focused on serving patients.
  • Health, dental, vision, life, disability, and flexible spending benefits.
  • Retirement and savings plan with company contributions and stock-based long-term incentives.
  • Discretionary annual bonus program and award-winning time-off plans.
  • Career development opportunities and flexible work models where applicable.
  • Visa sponsorship is not guaranteed.

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