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8 дней назад

Process Development Senior Scientist - Drug Product Technologies

126 066 - 170 560$
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 - Drug Product Technologies (ADC Drug Product Technologies): Developing liquid and lyophilized formulations and scalable fill/finish processes for antibody-drug conjugates and other biologic drug products with an accent on formulation, stability, critical quality attributes, and manufacturability. Focus on integrating analytical and process data, applying AI/ML to predictive modeling, and supporting regulatory submissions and clinical manufacturing technology transfers.

Location: On site in Thousand Oaks, California, United States

Salary: $126,066.05–$170,559.95 annual base salary

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

  • Develop liquid and lyophilized formulations and execute fill/finish process studies for biologics, especially antibody-drug conjugates.
  • Build process understanding across unit operations to support scalable, manufacturable drug products.
  • Evaluate critical quality attributes, in-use compatibility, stability, linker-payload integrity, and process-related degradation pathways.
  • Use high-throughput formulation screening, analytical data, AI/ML, and data science for predictive modeling and development decisions.
  • Author technical documents, risk assessments, control-strategy inputs, regulatory sections, and technology-transfer packages.
  • Support technology transfer, batch record review, process-fit assessments, manufacturing campaigns, and troubleshooting with internal and external partners.

Requirements

  • PhD, PharmD, or MD with relevant postdoctoral experience where applicable; or a master’s degree with 2 years of scientific experience; or a bachelor’s degree with 4 years of scientific experience.
  • PhD-level background in pharmaceutics, biotechnology, biochemistry, or a related field, with 2–4 years of postdoctoral or industry experience preferred.
  • Experience in biologics formulation development, stability testing, and fill/finish operations; direct ADC drug product formulation experience is strongly preferred.
  • Knowledge of ADC quality attributes, linker-payload stability, drug-to-antibody ratio, degradation, comparability, and clinical manufacturing.
  • Experience with analytical and biophysical techniques including UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, and subvisible particle analysis.
  • Strong communication skills and experience contributing to regulatory submissions such as CTAs and BLAs.

Nice to have

  • Experience applying AI/ML, large language models, or in silico tools to streamline research and development.
  • Experience advancing ADC candidates from discovery or preclinical development into clinical manufacturing.

Culture & Benefits

  • Collaborative, innovative, and science-based work environment.
  • Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
  • Retirement and savings plan with company contributions.
  • Annual discretionary bonus program and stock-based long-term incentives.
  • Paid time-off plans and career development opportunities.
  • Sponsorship for this role is not guaranteed.

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