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2 дня назад

Senior Manager Process Development (MSAT) (Biologics)

Π€ΠΎΡ€ΠΌΠ°Ρ‚ Ρ€Π°Π±ΠΎΡ‚Ρ‹
onsite
Π’ΠΈΠΏ Ρ€Π°Π±ΠΎΡ‚Ρ‹
fulltime
Π“Ρ€Π΅ΠΉΠ΄
senior
Английский
b2
Π‘Ρ‚Ρ€Π°Π½Π°
Singapore
Вакансия ΠΈΠ· списка Hirify.GlobalВакансия ΠΈΠ· Hirify Global, списка ΠΌΠ΅ΠΆΠ΄ΡƒΠ½Π°Ρ€ΠΎΠ΄Π½Ρ‹Ρ… tech-ΠΊΠΎΠΌΠΏΠ°Π½ΠΈΠΉ
Для мэтча ΠΈ ΠΎΡ‚ΠΊΠ»ΠΈΠΊΠ° Π½ΡƒΠΆΠ΅Π½ Plus

ΠœΡΡ‚Ρ‡ & Π‘ΠΎΠΏΡ€ΠΎΠ²ΠΎΠ΄

Для мэтча с этой вакансиСй Π½ΡƒΠΆΠ΅Π½ Plus

ОписаниС вакансии

ВСкст:
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TL;DR
Senior Manager Process Development (MSAT) (Biologics): Leading technology transfer, process validation, optimization, and commercial-scale support for protein biologics manufacturing with an accent on cell culture, purification, cGMP compliance, and product lifecycle management. Focus on troubleshooting complex process challenges, managing cross-functional projects and direct reports, and supporting regulatory filings, audits, and inspections.

Location: Singapore Manufacturing – Tuas, Singapore

Company

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

What you will do

  • Lead biologics technology transfer, process validation, and new technology evaluation and implementation projects.
  • Lead site activities for process optimization, complex investigations, troubleshooting, and product lifecycle management.
  • Manage the Process Development team and key cross-functional projects, delivering quality, schedule, cost, safety, and compliance objectives.
  • Apply advanced process engineering principles to support cGMP production of commercial protein biologics.
  • Collaborate with cross-functional and drug substance network teams to resolve complex technical challenges.
  • Support regulatory filings, audits, inspections, and other CMC activities as part of the Drug Substance Technology leadership team.

Requirements

  • Doctorate degree plus 2 years of relevant experience, master’s degree plus 6 years, or bachelor’s degree plus 8 years in biologics process development or commercial-scale technical support.
  • At least 8 years of technical experience supporting biotechnology processes in regulated environments, including cGMP, and at least 2 years of management experience.
  • Strong expertise in cell culture and/or purification processes.
  • Experience with process scale-up, technology transfer, process validation, troubleshooting, and complex investigations.
  • Knowledge of regulatory filings and inspections, commercial biopharmaceutical manufacturing, statistical analysis, analytical methods, and product quality attributes.
  • Strong oral and written communication skills for effective collaboration with internal and external stakeholders.

Culture & Benefits

  • Work in an environment focused on innovation, collaboration, inclusion, and professional growth.
  • Contribute to work aimed at improving outcomes for patients with serious illnesses.
  • Medical requirements and medical checks may apply to the role; the company covers related medical-check expenses.
  • Reasonable accommodations are available during the application process, interviews, and employment.

Π‘ΡƒΠ΄ΡŒΡ‚Π΅ остороТны: Ссли Ρ€Π°Π±ΠΎΡ‚ΠΎΠ΄Π°Ρ‚Π΅Π»ΡŒ просит Π²ΠΎΠΉΡ‚ΠΈ Π² ΠΈΡ… систСму, ΠΈΡΠΏΠΎΠ»ΡŒΠ·ΡƒΡ iCloud/Google, ΠΏΡ€ΠΈΡΠ»Π°Ρ‚ΡŒ ΠΊΠΎΠ΄/ΠΏΠ°Ρ€ΠΎΠ»ΡŒ, Π·Π°ΠΏΡƒΡΡ‚ΠΈΡ‚ΡŒ ΠΊΠΎΠ΄/ПО, Π½Π΅ Π΄Π΅Π»Π°ΠΉΡ‚Π΅ этого - это мошСнники. ΠžΠ±ΡΠ·Π°Ρ‚Π΅Π»ΡŒΠ½ΠΎ ΠΆΠΌΠΈΡ‚Π΅ "ΠŸΠΎΠΆΠ°Π»ΠΎΠ²Π°Ρ‚ΡŒΡΡ" ΠΈΠ»ΠΈ ΠΏΠΈΡˆΠΈΡ‚Π΅ Π² ΠΏΠΎΠ΄Π΄Π΅Ρ€ΠΆΠΊΡƒ. ΠŸΠΎΠ΄Ρ€ΠΎΠ±Π½Π΅Π΅ Π² Π³Π°ΠΉΠ΄Π΅ β†’