Our Team:

Within the EVolutive Facility (EVF) project, the EVF Process Biotechnologist represents process manufacturing team in activities from design phase to the establishment of routine operations. Process manufacturing operations includes both upstream and downstream biotechnology operations. He /she will closely work with both internal and external stakeholders. He / She will be part of the process manufacturing team to define, design, and implement a lean, flexible, and efficient set of operations. This includes aspects such as safety, digital elements, compliance, business process improvements and operational activities.

The EVF Process Manufacturing Biotechnologist will report to the EVF Process Manufacturing Coordinator (Supervisor).

Main responsibilities:

During Project Phase, the EVF Process Biotechnologist will participate in the following:

Engineering / Commissioning & Qualification activities:
• Review and approval of engineering drawings related to the process... manufacturing zones and services.
• Support Factory Acceptance Test (FAT) or Site Acceptance Test (SAT) for process equipment where required.
• Execute Installation, Operational Qualification (IOQ) activities for process equipment.

Operational and Digital Readiness
• Participating in safety related documents (Risk Assessments, PSSR, etc.) for process equipment and workflows.
• Authoring and reviewing of operational documents (work instructions, SOPs, training documents etc.) for process equipment and workflows.
• Support the digital and automation infrastructure setup including Delta V recipe, MES workflows, other process equipment related systems, ERP module setup, etc.

Tech Transfer from Sending Unit
• Preparation and execution for Engineering runs, PPQ runs in the EVF Singapore Site.
• Authoring and reviewing process related documents.

Working hours – Personnel shall be able to work office hours (weekdays) on Sanofi Site Office to support collaborations and meetings with stakeholders. Work from Home (hybrid) arrangements may be available during the Project Phase.

During Routine Operations, the EVF Process Biotechnologist will be responsible for:
• Complete full training and qualification to perform all operations relevant to manufacturing areas assigned.
• Perform well-defined operations procedure within the GMP Manufacturing setting for Process Manufacturing team.
• Perform general housekeeping activities such as equipment monitoring, basic 6S housekeeping, and cleaning (sanitization).
• Competent user of digital and automation applications and software related to the Process Manufacturing systems and work areas.
• Participate in engagement and projects with cross functional Support Functions like QA, Supply Chain, MTech, etc.
• Conduct Training activities to the team for specific assigned workflows and procedures.
• Drive or support change control projects, continuous improvement initiatives and projects within Process Manufacturing Team to improve safety, quality and lower cost of goods and services.
• Possess a strong understanding of critical process/operational parameters and target/acceptable ranges, as well as interactions between different process parameters.
• Investigate deviations and exceptions including process abnormalities and critical alarms on QMS. Take immediate actions to minimize product and schedule impact.

Working hours – Personnel shall be able to work 12 hours rotating shift (including day/night, and weekends) on site to support production activities.

About you
• Experience: 3 Years of experience in Biopharmaceutical Manufacturing (biologics or vaccines). Familiarity and prior working experience with Single Use Systems would be preferred. Good knowledge and experience in both upstream and downstream activities (Good knowledge and interest to work with fully digital and automated systems will be preferred. Systems including but not limited to Enterprise Resource Systems (ERPs), autonomous guided vehicles (AGVs), robotics, conveyor systems, Quality Management Systems (QMS), etc.
• Soft Skills: 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 and self-organized. Proactive and result oriented. Start-up and /or commissioning, qualification of a biopharmaceutical facility would be an advantage.
• Education: Degree, Diploma or Higher Nitec in Engineering / Life Science / Biology /Chemistry

Sanofi Behaviors and Skills

This position is required to demonstrate behaviors such as Stretch, Put the interest of the organization, Act in the interest of our patients and customers and Take Action. During the interview we will also be asking for examples of skills such as Strategic Thinking, Result Orientation, People Leadership (if applicable), Relationship and Influence.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all
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