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Associate Consultant - CMC Development & Analytics (Pharmaceutical CMC)

120 000 - 137 000$
Формат работы
hybrid
Тип работы
fulltime
Грейд
middle
Английский
c1
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
Associate Consultant - CMC Development & Analytics (Pharmaceutical CMC): Supporting pharmaceutical CMC development and analytics engagements across biologics manufacturing, process development, tech transfer, process validation, and future lab operating models with an accent on data-driven insights and technology-enabled transformation. Focus on analyzing CMC and manufacturing data, designing future-state lab and CMC operating models, and translating scientific findings into clear client recommendations.

Location: South San Francisco, California, United States; hybrid working model with work-from-home and on-site presence at client or hirify.global offices

Salary: $120,000–$137,000 per year

Company

hirify.global is a management consulting and technology firm combining data, science, technology, and human ingenuity to develop solutions and technology products for clients in life sciences and other critical business areas.

What you will do

  • Support client engagements in pharmaceutical CMC development, biologics manufacturing, process science, drug substance and drug product development, and manufacturing analytics.
  • Analyze data from CMC, manufacturing, quality, regulatory, and development systems to generate actionable insights.
  • Contribute to process development, formulation, analytical chemistry, tech transfer, process validation, and regulatory readiness projects.
  • Help design future-state CMC and laboratory operating models, including processes, roles, systems, data flows, and technology enablement.
  • Translate scientific, manufacturing, and analytical findings into clear business recommendations for client stakeholders.
  • Support project planning, workstream execution, deliverable development, and day-to-day client engagement.

Requirements

  • Bachelor’s or master’s degree in chemical engineering, biochemical engineering, mechanical engineering, materials engineering, chemistry, biotechnology, pharmaceutical sciences, or a related technical discipline; a PhD may substitute for work experience.
  • At least 2.5 years of relevant pharmaceutical or biopharmaceutical CMC experience, preferably with biologics; small molecule experience is also acceptable.
  • Hands-on experience in at least one CMC function, such as process development, process engineering, process chemistry, formulation, analytical chemistry, or drug substance or drug product manufacturing.
  • Strong understanding of unit operations, process characterization, scale-up, tech transfer, process validation, manufacturing readiness, QbD, CQAs, CPPs, and control strategy.
  • Familiarity with CMC regulatory milestones and systems such as ELN, LIMS, ERP, LCM, PLM, and MES, plus experience with data analytics, modeling, reporting, visualization, AI-enabled tools, or technology solutions.
  • Fluent English and authorization to work in the United States without now or future employer sponsorship are required. Some consulting or client-facing experience is expected.

Culture & Benefits

  • Cross-functional skills development, custom learning pathways, and milestone training programs.
  • Internal mobility paths supporting individual contribution, role expansion, and career progression.
  • Comprehensive rewards supporting health and well-being, financial security, time away, and professional development.
  • Collaborative, client-first working environment with flexible work-from-home and on-site arrangements.
  • Travel is required for client-facing employees as determined by project and client needs.

Hiring process

  • Submit an online application with a full set of official or unofficial transcripts.

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