Job Description

Job title: Lead/Senior Biotechnologist, Process Manufacturing

Location: EVolutive Facility (EVF) at 5 Tuas South Street 2, Singapore 639328

• Work hours arrangement: During Project phase, successful candidates will be working on office hours schedule from 8am to 5pm.
• Once the site enters into Routine Operation, hires must be able to support 12 hours rotating shift (including day/night, weekends and Public holidays) on site to support manufacturing activities.
• Successful candidates will be remunerated Shift allowances accordingly upon commencement of Rotational Shift Support.
• Company transport provision at designated MRT Station.
• Experience in Biopharmaceutical Manufacturing (biologics or vaccines) is advantageous.
• Job grade and seniority of the role will commensurate with the applicant\xe2\x80\x99s qualification, skillsets, and experience.
• Candidates with leadership exposure and experience may be considered for Senior/Lead Biotechnologist role.

About the job

Our Team:

Our manufacturing sites are state-of-the-art, powered by big data and digital. It is the bridge between scientific advances and transformative medicine serving millions of people around the world.

Sanofi has added two new Evolutive Facilities to our global industrial footprint. These production units (EVF) represent the future of manufacturing. They allow us to increase our capacities while making production more flexible and respectful of the environment.

Fully digitalized, our Evolutive Facilities (EVF) will enable more responsive and flexible manufacturing across multiple vaccine and biological platforms including mRNA, while minimize our impact to the environment. Our EVFs will help improve people\xe2\x80\x99s lives by giving them faster access to more treatments.

Main responsibilities:

Within the Evolutive Facility (EVF) project, the Biotechnologist, Process Manufacturing participates 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 process manufacturing strategy. The strategy includes aspects such as safety, digital elements, compliance, business process improvements and operational activities.

Process manufacturing operations includes both upstream and downstream process operations. He / She will be part of the process manufacturing 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 operations to support different modalities for both Clinical and Commercial production in the EVF.

This role will report to the Manager, Process Manufacturing. The mission\xe2\x80\x99s scope includes active participation for EVF Greenfield project in Singapore only.

Key accountabilities

From Project Phase, the Biotechnologist, Process Manufacturing 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 manufacturing systems and equipment where required.
• Execute Installation, Operational Qualification (IOQ) activities for process manufacturing systems and equipment.

Operational and Digital Readiness

• Participating in safety related documents (Risk Assessments, PSSR, etc.) for equipment and workflows.
• Authoring and reviewing of operational documents (work instructions, SOPs, training documents etc.) for 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 for operations systems and equipment.

During Routine Operations, the Biotechnologist, Process Manufacturing 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.
• 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 operations systems and work areas.
• Candidates with experiences in the following activities, may be considered for Senior or Lead roles.

• 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 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.

About you

Experience:

• 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 either upstream or downstream operations.
• 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 and presentation skills
• Collaborative 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
• Adaptable, relationship focused, self-organized, proactive, result-oriented, engaging, dynamic

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn\xe2\x80\x99t happen without people \xe2\x80\x93 people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let\xe2\x80\x99s be those people. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our and check out our Diversity Equity and Inclusion actions at !

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