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2 дня назад

NPI Chemist III

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
NPI Chemist III (Analytical Sciences/Pharmaceutical Manufacturing): Supporting new product introduction and technology transfer through complex analytical testing, method development, validation, laboratory readiness, and customer-facing technical leadership with an accent on cGMP, GLP, data integrity, and aseptic pharmaceutical operations. Focus on leading analytical workstreams, troubleshooting HPLC and related instrumentation, managing investigations and risk assessments, and coordinating cross-functional and external laboratory activities.

Location: Albuquerque, NM, United States; onsite role.

Company

Contract development and manufacturing organization supporting pharmaceutical and biotech companies with drug development, technology transfer, and commercial manufacturing.

What you will do

  • Act as the functional subject matter expert for assigned new product introduction and technology transfer projects from initiation through commercial launch.
  • Lead analytical workstreams covering method assessment, development, transfer, verification, validation, comparability, stability, protocol execution, laboratory readiness, and report preparation.
  • Perform, review, troubleshoot, interpret, trend, and summarize analytical testing for raw materials, in-process samples, finished products, stability samples, water, and particulates.
  • Use and provide technical expertise on laboratory instrumentation including balances, pipettes, pH meters, UV/Visible spectrophotometers, TOC analyzers, IR, and HPLC.
  • Prepare customer-facing presentations, technical updates, protocols, reports, investigations, change controls, specifications, and technical summaries while ensuring inspection-ready documentation and data integrity.
  • Coordinate with Quality, Manufacturing, Validation, Engineering, Regulatory, Project Management, customers, and external laboratories on risks, investigations, testing schedules, deliverables, and operational readiness.

Requirements

  • Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific field.
  • At least five years of experience in chemistry and new product introductions or a related role.
  • Experience with aseptic or sterile operations in a pharmaceutical or related industry is preferred.
  • Advanced analytical expertise with complex testing, laboratory instrumentation, method development, transfer, verification, validation, and data interpretation.
  • Knowledge of pharmaceutical regulatory and compliance requirements, including cGMP, GLP, safety, aseptic gowning, and data-integrity expectations.
  • Ability to lead risk assessments, gap analyses, readiness reviews, investigations, root-cause analysis, corrective and preventive actions, and technical problem resolution.
  • Ability to author, review, and execute analytical protocols and reports and to interpret SOPs and regulatory requirements.
  • Ability to work independently, meet deadlines under pressure, communicate technical information clearly, and collaborate with cross-functional and customer-facing teams.
  • Must pass a background check and drug screen. Occupational health screening, gowning certification, media qualification, and respirator use may be required.

Nice to have

  • Aseptic or sterile experience in a pharmaceutical or related industry.
  • Experience mentoring, coaching, and cross-training laboratory personnel.

Culture & Benefits

  • Paid training, vacation, and holidays, with vacation accrual beginning on the first day of employment.
  • Benefits eligibility from the first day of employment.
  • 401(k) program with matching contributions.
  • Education reimbursement, learning platform, and career advancement opportunities.
  • Safety-focused, compliant, collaborative, and quality-oriented laboratory environment.

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