Sanofi Manufacturing and Supply (M&S) Organization is preparing its future through an ambitious program named Modulus. The facility is at the cornerstone of Sanofi strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable, and agile, leveraging new disruptive technologies, to better address vaccine business challenges as well as Specialty Care Biologics products. One of these two Modulus Facilities is constructed in Singapore at a new Greenfield site, with a design identical to the one in Neuville (France). The facilities will also have highly digitalized and automated capabilities which is a key enabler for operations using technologies such as autonomous guided vehicles, cobots and cloud systems.

This role will have the title of Senior Biotechnologist, Manufacturing and will report to the Manager, Manufacturing. The successful candidate will be part of the pioneer batch of the manufacturing operations shift team who will directly participate in the Engineering and Product Validation Runs in the state-of-the-art facility planned for early 2025.

The candidate will have a routine operational role consisting of the following:

Perform and complete ongoing commissioning and qualification activities of equipment, digital and automation related systems.

Execute routine GMP manufacturing activities in the manufacturing operations team in accordance with Process, Quality and Safety standards.

Conduct Training activities to the team for specific assigned workflows and procedures.

Ensure general housekeeping of all manufacturing areas.

Support ongoing regulatory and audit readiness and preparation.

User of key digital and automation applications and software related to manufacturing systems such as ERP, MES, PCS, etc.

Support continuous improvement and optimization projects.

Investigate deviations and exceptions including process abnormalities and critical alarms on QMS. Take immediate actions to minimize product and schedule impact.

Sanofi EVF Singapore is hiring for Senior Biotechnologist, Manufacturing for the following teams:

Upstream Manufacturing Process

Downstream Manufacturing Process

Central Manufacturing Services (Media & Buffer, Logistics)

Performance Standards: Duties & Responsibilities

Key Areas

Action Areas, Deliverables and Outcomes

Weightage

(Total 100%)

Commissioning and Qualification Activities, Operational Readiness

Perform and execute commissioning activities for manufacturing equipment and systems.

Support the documentation readiness for procedures, risk assessment and other training documents for the manufacturing equipment and systems.

20%

Tech Transfer

Participate and complete all related trainings to perform the tech transfer runs.

30%

cGMP Manufacturing Operations

Perform and participate in the Engineering Runs and other Product Validation Runs

50%

Pre-requisites

Knowledge, Skills & Competencies / Language

Good communication skills and a team player

Proven ability to work as part of an integrated, networked team, and collaborate across functional, organizational, and location boundaries and be people-first values driven

Excellent analytical, consultative, and diagnostic skills with ability to make sound, data-based business decisions.

Engaging, dynamic

Adaptable, relationship focused.

Self-organized.

Proactive, Result-oriented.

Start-up and /or commissioning, qualification of a biopharmaceutical facility would be an advantage.

Familiarity and prior working experience with Single Use Systems would be preferred.

Good knowledge and experience in related GMP operations based on the manufacturing team.

Good knowledge and interest to work with fully digital and automated systems will be preferred. Systems including but not limited to Manufacturing Execution Systems (MES), Enterprise Resource Systems (ERPs), Autonomous Guided Vehicles (AGVs), robotics, conveyor systems, Quality Management Systems (QMS), etc.

Qualifications / Requirements

Bachelor's degree (in Engineering / Life Science / Biology / Chemistry) with 3 Years of experience in Biopharmaceutical Manufacturing (biologics or vaccines).

Diploma (in Engineering / Life Science / Biology / Chemistry) with 5 Years of experience in Biopharmaceutical Manufacturing (biologics or vaccines).

Any other requirements of the job

Senior Biotechnologist will be working in a twelve-hour rotating shift pattern consisting of day and night shifts which will include weekend workdays when the facility is fully operational expected to be in early 2025.