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8 дней назад

Director, Analytical Technical Operations (mRNA)

167 000 - 300 700$
Формат работы
onsite
Тип работы
fulltime
Грейд
director
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
Director, Analytical Technical Operations (mRNA): Leading a 30–50-person analytical testing and integrations organization that generates filing-ready data for CMC development, product characterization, stability, release and Module 3 submissions with an accent on RNA/lipid analytics, non-GMP testing and digital laboratory operations. Focus on building integrated testing capacity, monitoring method performance, improving laboratory throughput, modernizing Benchling and LabVantage workflows, and connecting development analytics with GMP QC execution.

Location: 100% onsite in Norwood, Massachusetts, United States. Only U.S. persons—citizens, permanent residents, asylees, or refugees—are eligible because of U.S. export control requirements; hirify.global cannot sponsor non-U.S. persons for an export control license.

Salary: $167,000–$300,700 per year, plus potential discretionary bonus, incentive compensation, or equity subject to eligibility and performance.

Company

hirify.global develops mRNA technology, medicines, and manufacturing capabilities to transform medicine.

What you will do

  • Lead the Core Analytical Testing & Integrations organization of approximately 30–50 scientists, analysts, managers, and integration specialists.
  • Set strategy, capacity plans, execution standards, testing priorities, and continuous-improvement initiatives across analytical operations.
  • Oversee non-GMP testing for process development, characterization, release, stability, engineering runs, and PPQ-related activities, plus a limited portfolio of phase-appropriate GMP testing with QC and QA.
  • Ensure controlled, reproducible, traceable, filing-ready analytical data supports CMC development, Module 3 submissions, and Regulatory CMC requests.
  • Build method-performance monitoring, dashboards, scheduling, stability coordination, capacity planning, and issue-escalation processes.
  • Improve laboratory efficiency through standardized workflows, Lean practices, automation, equipment optimization, digital workflows, and appropriate Generative AI applications.

Requirements

  • Degree in analytical chemistry, chemistry, biochemistry, molecular biology, pharmaceutical sciences, life sciences, engineering, or a related technical discipline.
  • 15 years of relevant industry experience with a Bachelor’s degree, or 10 years of relevant experience with a PhD, in analytical development, analytical testing, technical operations, Quality Control, or related CMC laboratory functions.
  • Experience leading multi-technology analytical testing for development, non-GMP release, and stability involving mRNA/LNP, vaccines, biologics, or other complex modalities.
  • Technical fluency across separations, RNA and lipid analyses, biophysical and compendial assays, molecular biology, sequencing, and microbiology, including bioburden and endotoxin testing.
  • Experience generating controlled analytical datasets, traceable source documentation, and regulatory data supporting Module 3 filings and data requests.
  • Knowledge of non-GMP data integrity, fit-for-purpose methods, lifecycle management, and phase-appropriate GMP requirements for early clinical programs.
  • Experience with analytical trending, method-performance monitoring, investigations, improvements, and development-to-GMP QC transfer.
  • Experience building scheduling, stability, metrics, portfolio prioritization, and capacity-planning processes across stakeholders.
  • Proven people leadership through managers, including hiring, coaching, performance management, development, succession, and retention, plus executive communication across CMC functions.

Nice to have

  • PhD in a relevant scientific or engineering discipline.
  • Experience evolving ELN/LIMS environments, ideally Benchling and LabVantage, structured data models, digital interfaces, and automation-enabled laboratory workflows.
  • Track record improving laboratory productivity, turnaround time, right-first-time performance, and resource utilization while maintaining reliable delivery and high-quality data.

Culture & Benefits

  • In-person, site-based work emphasizing real-time collaboration, direct mentorship, and hands-on partnership.
  • Healthcare and voluntary benefits, fitness and mental-health support, and family-planning benefits including fertility, adoption, and surrogacy support.
  • Paid time off including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
  • Savings and investment programs, location-specific perks, and a smoke-free, alcohol-free, and drug-free workplace.
  • Work is performed with high standards for quality, data integrity, training, environmental health and safety, and human oversight of digital and AI tools.

Hiring process

  • Applicants must meet the stated basic qualifications and be eligible to access U.S. export-controlled technology or data as a U.S. person.
  • Reasonable accommodations for the hiring process or essential job functions are available through hirify.global’s Accommodations team.

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