Job Description

Mission

Within the Evolutive Facility (EVF) project, the EVF General Services Lead Biotechnologist represents Operations General Services in activities from design phase to the establishment of routine operations. He /she will closely work with both internal and external stakeholders. In so doing, to define, design and implement the EVF overall General Services strategy. The strategy includes aspects such as safety, digital elements, compliance, business process improvements and operational activities.

General Services Operations includes Media & Buffer Preparation and Supply, Waste Management, Material & Equipment Management, Kitting, etc. He / She will be part of the General Services team to define, design, and implement a lean, flexible, and efficient set of operations. The approach should focus on the agility and ease of the General Services Operations to support different modalities for both Clinical and Commercial production in the EVF.

The EVF General Services Lead Biotechnologist will report to the EVF General Services Coordinator (Supervisor). The mission\xe2\x80\x99s scope includes active participation for EVF Greenfield project in Singapore only.

Key accountabilities

From Project Phase, the EVF General Services Lead Biotechnologist will participate in the following:

Engineering / Commissioning & Qualification activities:

• Review and approval of engineering drawings related to the General Services zones and services.
• Support Factory Acceptance Test (FAT) or Site Acceptance Test (SAT) for General Services systems and equipment where required. This might involve overseas travel.
• Execute Installation, Operational Qualification (IOQ) activities for General Services systems and equipment.

Operational and Digital Readiness

• Participating in safety related documents (Risk Assessments, PSSR, etc.) for General Services equipment and workflows.
• Authoring and reviewing of operational documents (work instructions, SOPs, training documents etc.) for General Services equipment and workflows.
• Support the digital and automation infrastructure setup including Delta V recipe, MES workflows, AGV management, 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 the General Services systems and equipment.

Working hours \xe2\x80\x93 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 General Services Lead Biotechnologist will be responsible for:

• Complete full training and qualification to perform all operations relevant to manufacturing areas assigned.
• Perform well-defined operations procedures within the GMP manufacturing setting for General Services.
• 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 General Services 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 the General Services 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 \xe2\x80\x93 Personnel shall be able to work 12 hours rotating shift (including day/night, and weekends) on site to support production activities.

Skills and knowledge expected

• 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 General Services activities (Media & Buffer Preparation operations, Kitting/Material Preparation operations, etc.)
• 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.
• Prior first line leadership experience in a Manufacturing Operations Team is preferred.

Education and experience

• Bachelor\xe2\x80\x99s degree (in Engineering / Life Science / Biology /Chemistry) with

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

7 Years of experience in Biopharmaceutical Manufacturing (biologics or vaccines). * Higher NITEC (in Engineering / Life Science / Biology /Chemistry) with

10 Years of experience in Biopharmaceutical Manufacturing (biologics or vaccines).

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.

Sanofi