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8 дней назад

Upstream Process Development Lead (Biotechnology)

106 000 - 176 600$
Формат работы
onsite
Тип работы
fulltime
Грейд
lead
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
Upstream Process Development Lead (Biotechnology): Leading upstream process development for mammalian cell culture and microbial fermentation platforms supporting recombinant protein and vaccine antigen production with an accent on bioreactor development, media and feed optimization, scale-up, and GMP process readiness. Focus on designing complex DOE-based studies, integrating yield and quality data, leading technology transfer, and solving cross-platform process development challenges.

Location: United States - New York - Pearl River. Laboratory-based role with occasional work outside core hours and on weekends; permanent U.S. work authorization is required.

Annual base salary: $106,000-$176,600, plus a 15% bonus target and eligibility for a share-based long-term incentive program.

Company

hirify.global develops medicines and vaccines through research, development, and biopharmaceutical manufacturing programs.

What you will do

  • Lead scientific and people leadership for upstream process development across mammalian cell culture and microbial fermentation.
  • Design, prioritize, execute, document, and communicate complex studies focused on cell growth, recombinant protein expression, product yield, and quality.
  • Evaluate and optimize production hosts and cell lines, inoculum and seed-train strategies, media, feeds, and bioreactor parameters.
  • Apply high-throughput experimentation, automation, Design of Experiments, mechanistic modeling, and scale-down approaches.
  • Lead upstream scale-up and technology-transfer activities and author or review development and transfer documentation.
  • Coach scientists and collaborators, provide scientific judgment, and coordinate cross-functional project activities.

Requirements

  • PhD in biochemical or chemical engineering, microbiology, cell biology, biotechnology, biochemistry, or a related field with at least five years of relevant experience; or MS/BS with at least 10 years of relevant experience.
  • Deep hands-on expertise in mammalian cell culture or microbial fermentation using automated, high-throughput, or conventional bioreactor systems, with sufficient experience to lead work across both platforms.
  • Experience developing and optimizing bench-scale bioreactor processes, including seed trains, media and feed optimization, process parameters, sampling, and data interpretation.
  • Experience with recombinant protein or vaccine-antigen expression and assessment of upstream effects on product yield and quality.
  • Experience with DOE, statistical analysis, mechanistic modeling, scale-up, GMP manufacturing, and technology transfer.
  • Must be authorized to work in the U.S. by any employer; U.S. work visa sponsorship is not available.

Nice to have

  • Experience across both mammalian and microbial platforms, including CHO, bacterial, or yeast expression systems.
  • Experience with Quality by Design, process characterization, scale-down models, continuous processing, process monitoring, or process control.
  • Knowledge of GMP, ICH guidelines, regulatory expectations, CMC development, process performance qualification, continued process verification, or biologics documentation.
  • Experience with downstream purification, protein chemistry, analytical characterization, cell-line or strain development, automation, digital tools, or complex datasets.

Culture & Benefits

  • Full-time employment in a laboratory-based process development environment.
  • Comprehensive medical, prescription drug, dental, and vision coverage.
  • 401(k) plan with matching contributions and an additional retirement savings contribution.
  • Paid vacation, holidays, personal days, caregiver and parental leave, and medical leave.
  • Relocation assistance may be available based on business needs and eligibility.

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