startupprocess developmentquality systemsroot cause analysisngsprocess validationdesign of experimentsformulationmolecular biologypcrtechnical transfer
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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$80к-95к/год
$120к$140кмедиана$170к
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Чёткая ответственность за разработку и перенос процессов в производство даёт сильный технический опыт, хотя в стартапе возможны высокий темп и смена приоритетов.
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Описание вакансии
Текст:
Hirify AI/Оригинал
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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