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7 дней назад

Contract Development and Manufacturing Manager

Формат работы
onsite
Тип работы
fulltime
Английский
b2
Страна
Singapore
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
Contract Development and Manufacturing Manager (Pharmaceutical Manufacturing): Leading external analytical strategy and execution for synthetic therapeutics across development, clinical, and commercial programs with an accent on analytical method development, validation, quality, and regulatory compliance. Focus on managing CDMO and testing-laboratory partnerships, coordinating cross-functional workstreams, and mitigating risks affecting validation readiness and product release.

Location: Singapore, Singapore

Company

hirify.global is a biotechnology and pharmaceutical company developing medicines for serious illnesses through biology and technology.

What you will do

  • Lead external analytical strategy and execution across development, clinical, and commercial programs.
  • Serve as the primary analytical interface for CDMOs and contract testing laboratories.
  • Lead method development, transfer, qualification, validation, reference standard management, release, and stability activities.
  • Coordinate analytical planning and execution with Process Development, Attribute Sciences, Quality, Supply Chain, and Regulatory teams.
  • Oversee proposals, scopes, work orders, performance tracking, issue resolution, and escalation for external analytical operations.
  • Identify and mitigate analytical risks affecting timelines, validation readiness, product release, quality, compliance, and cost.

Requirements

  • Doctorate degree, or a relevant master's degree with 2 years of pharmaceutical or GMP experience, bachelor's degree with 4 years of experience, or diploma with 8 years of experience.
  • Degree or diploma in Synthetic Organic Chemistry, Analytical Chemistry, Chemical Engineering, or Life Sciences.
  • Experience in analytical development, quality control, or external analytical oversight in the pharmaceutical or biotechnology industry.
  • Experience managing CDMOs, contract testing laboratories, or external laboratory networks.
  • Strong project management, coordination, relationship management, communication, and conflict-resolution skills.
  • Understanding of drug development, cGMP, regulatory and CMC requirements, pharmaceutical quality systems, change management, deviation investigations, and CAPA implementation.

Nice to have

  • Experience with synthetic therapeutics, including small molecules, peptides, or oligonucleotides.
  • Experience supporting commercial analytical readiness, release, and lifecycle management.

Culture & Benefits

  • Collaborative, inclusive, and matrixed working environment.
  • Professional development and career growth opportunities.
  • Competitive benefits supporting professional and personal development.
  • Medical checks required for the role are arranged with related expenses covered by hirify.global.

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