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8 дней назад

Scientist II, QC Analytical (Biotech)

124 000 - 165 500$
Формат работы
onsite
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
Scientist II, QC Analytical (Biotech): Performing GMP-compliant analytical quality control testing for raw materials, in-process samples, drug substances, water, and final drug products with an accent on analytical methods, documentation, and laboratory systems. Focus on reviewing test data, investigating OOS/OOT results and deviations, validating equipment and methods, and maintaining regulatory compliance.

Location: Framingham, United States; 5-day on-site expectation

Salary: $124,000–$165,500 annual base pay, plus performance incentive bonus and equity eligibility

Company

hirify.global develops oncolytic immunotherapies designed to stimulate local and systemic anti-tumor responses for cancer treatment.

What you will do

  • Perform analytical QC testing of raw materials, in-process samples, water, drug substance, and final drug products according to SOPs and cGMP requirements.
  • Establish, revise, and maintain QC analytical procedures and laboratory systems.
  • Review testing data and GMP documentation completed by analysts.
  • Generate protocols and reports for QC method qualifications and support equipment validation.
  • Manage change controls, deviations, CAPAs, OOS/OOT events, and laboratory investigations.
  • Coordinate sample storage, retention inventory, contract laboratory shipments, audits, and regulatory inspections.

Requirements

  • BA or BS in analytical chemistry or a related science, preferably with chemistry coursework.
  • 5+ years of experience in a GMP/GLP or similar environment.
  • Knowledge of analytical techniques and practical experience in an analytical laboratory.
  • Understanding of USP/EP monograph testing and requirements.
  • Computer literacy with MS Word and Excel, strong communication and organizational skills.
  • Ability to work independently and collaboratively in a team.

Culture & Benefits

  • Collaborative, bold, dedicated, and candid working principles.
  • Medical, dental, and vision insurance.
  • 401(k) match and flexible time off.
  • Paid holidays, including a year-end shutdown.
  • Annual performance incentive bonus, new-hire equity, and ongoing performance-based equity opportunities.

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