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6 дней назад

Process Development Scientist I (Biotech)

80 000 - 95 000$
Формат работы
hybrid
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 Scientist I (Biotech): Designing, optimizing, and transferring formulation and manufacturing processes for molecular biology products with an accent on scale-up, technical transfer, process validation, and data-driven troubleshooting. Focus on leading design transfer, root cause investigations, process characterization, and cross-functional implementation in a regulated manufacturing environment.

Location: Boulder, Colorado, onsite/in-office, with flexibility to work from home one day a week. Local candidates preferred.

Base compensation: $80,000–$95,000 per year, plus bonus and equity.

Company

hirify.global develops molecular biology products and is scaling operations across sites in Boulder and Cape Town.

What you will do

  • Design and execute formulation and process development studies, including DOE-based experiments, for scale-up, optimization, technical transfer, and process characterization.
  • Translate laboratory-scale processes into robust, manufacturing-ready workflows and lead design transfer into manufacturing.
  • Plan and execute process validation, qualification of raw materials and equipment, and process monitoring with Validation and Quality.
  • Analyze complex datasets, define critical process parameters, establish process capability metrics, and provide technical recommendations.
  • Lead troubleshooting, root cause investigations, NCR and CAPA actions, and process improvements.
  • Collaborate with R&D, Manufacturing, Quality, and Product Management; provide technical guidance and training to Research Associates.

Requirements

  • BS/BA with 8 years of industry experience, MS with 6 years, or PhD with no industry experience; applicants with more experience are welcome.
  • Ability to independently design, execute, and interpret experiments with scientific rigor.
  • Hands-on molecular biology experience, including PCR, qPCR, electrophoresis, nucleic acid quantification and fragment analysis, and NGS workflows.
  • Experience with reagent or enzyme formulation and analytical measurements including spectrophotometry, fluorometry, pH/conductivity, osmolality or freezing point depression, viscometry, and densitometry.
  • Experience designing, characterizing, and implementing processes in manufacturing or regulated environments, including scale-up or technical transfer.
  • Experience leading root cause investigations through resolution and translating data into clear technical recommendations for varied scientific audiences.
  • Strong organizational, interpersonal, documentation, record-keeping, and reporting skills, with the ability to manage multiple priorities with minimal supervision.

Nice to have

  • Biotech and start-up experience.
  • Experience developing and optimizing automated liquid-handling methods for reagent preparation, formulation, or filling.
  • Experience validating spreadsheets in a regulated environment, including documented calculation verification and access controls.
  • Working knowledge of process validation, including IQ/OQ/PQ/PPQ, and stable, capable process design.
  • Proficiency with DOE, ANOVA, regression, capability analysis, and statistical tools such as JMP or Minitab.
  • Working knowledge of quality systems such as ISO 13485, NCR, CAPA, and change control.
  • Experience training or providing technical guidance to junior staff.

Culture & Benefits

  • Full-time employee role in a dynamic, fast-paced environment with direct ownership of projects moving products from R&D into production.
  • Flexible Time Off, holidays, paid parental leave, and an Employee Assistance Program.
  • Employer covers 75% of the base medical plan, with buy-up options; employer-paid dental and vision coverage.
  • Employer-paid $25,000 life and AD&D policy and a 401(k) retirement plan with a 4% match.
  • Work closely with cross-functional teams across Boulder and Cape Town while following internal QMS and applicable standards.

Hiring process

  • Submit a PDF application directly through watchmakergenomics.com containing a motivation letter and resume or curriculum vitae highlighting relevant qualifications and experience.
  • Applications without a motivation letter will not be considered. Applications are reviewed on a rolling basis until the position is filled.
  • If selected for interviews, provide contact information for three professional references. Direct applications only; recruitment agencies are not accepted.

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