2 Π΄Π½Ρ Π½Π°Π·Π°Π΄
Senior Manager Process Development (MSAT) (Biologics)
ΠΡΡΡ & Π‘ΠΎΠΏΡΠΎΠ²ΠΎΠ΄
ΠΠ»Ρ ΠΌΡΡΡΠ° Ρ ΡΡΠΎΠΉ Π²Π°ΠΊΠ°Π½ΡΠΈΠ΅ΠΉ Π½ΡΠΆΠ΅Π½ Plus
ΠΠΏΠΈΡΠ°Π½ΠΈΠ΅ Π²Π°ΠΊΠ°Π½ΡΠΈΠΈ
Π’Π΅ΠΊΡΡ:
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 β Tuas, Singapore
Company
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, masterβs degree plus 6 years, or bachelorβs 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.
ΠΡΠ΄ΡΡΠ΅ ΠΎΡΡΠΎΡΠΎΠΆΠ½Ρ: Π΅ΡΠ»ΠΈ ΡΠ°Π±ΠΎΡΠΎΠ΄Π°ΡΠ΅Π»Ρ ΠΏΡΠΎΡΠΈΡ Π²ΠΎΠΉΡΠΈ Π² ΠΈΡ ΡΠΈΡΡΠ΅ΠΌΡ, ΠΈΡΠΏΠΎΠ»ΡΠ·ΡΡ iCloud/Google, ΠΏΡΠΈΡΠ»Π°ΡΡ ΠΊΠΎΠ΄/ΠΏΠ°ΡΠΎΠ»Ρ, Π·Π°ΠΏΡΡΡΠΈΡΡ ΠΊΠΎΠ΄/ΠΠ, Π½Π΅ Π΄Π΅Π»Π°ΠΉΡΠ΅ ΡΡΠΎΠ³ΠΎ - ΡΡΠΎ ΠΌΠΎΡΠ΅Π½Π½ΠΈΠΊΠΈ. ΠΠ±ΡΠ·Π°ΡΠ΅Π»ΡΠ½ΠΎ ΠΆΠΌΠΈΡΠ΅ "ΠΠΎΠΆΠ°Π»ΠΎΠ²Π°ΡΡΡΡ" ΠΈΠ»ΠΈ ΠΏΠΈΡΠΈΡΠ΅ Π² ΠΏΠΎΠ΄Π΄Π΅ΡΠΆΠΊΡ. ΠΠΎΠ΄ΡΠΎΠ±Π½Π΅Π΅ Π² Π³Π°ΠΉΠ΄Π΅ β
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