Senior Biotechnologist, Manufacturing

Job title: Senior Biotechnologist, EVF

• Location: Tuas, Singapore

About the job:

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

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’s lives by giving them faster access to more treatments.

Main responsibilities:

Senior Biotechnologist, Manufacturing is a role within the Manufacturing Department of the EVF project in Tuas, Singapore. This role is catered for candidates with either a degree or a diploma from relevant disciplines with relevant working experience in the biopharmaceutical industry. The successful candidate will have the opportunity to be part of either the Process Manufacturing (PM) or Central Manufacturing Services (CMS) Team. This candidate will have significant learning and developmental opportunities to work cross functionally with other departments.

The role will report to the Manager, Manufacturing. The role includes active participation in EVF Greenfield project in Singapore initially and eventually will be part of the manufacturing team of Sanofi to perform the Engineering, Process Performance Qualification (PPQ) and commercial batches.

During the project phase, the Senior Biotechnologist, Manufacturing will participate in the design and execution of the following:

• Execution of engineering / Commissioning & Qualification (C&Q) activities of the manufacturing facility, equipment, and respective systems.

• Operational and Digital Readiness for manufacturing systems and workflows including but not limited to the performance of user (site) acceptances tests and preparation of operational documents.

Beyond the project phase, the Senior Biotechnologist, Manufacturing will have a routine operational manufacturing role not limited to the following:

• Routine GMP manufacturing activities in the operational manufacturing team.

• User of digital and automation applications and software related to manufacturing systems.

• Participation in continuous improvement and optimization projects.

Commissioning & Qualification (CQ)

• Execute commissioning and qualification protocols for manufacturing equipment and systems (functional and automation testing).

• Support any investigation for exceptions and implementing changes during the CQ phase if required.

Operational and Digital Readiness, Tech Transfer

• Authoring and reviewing of 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.

• Perform performance testing and qualification for the digital systems related to manufacturing equipment and workflows.

• Perform and run the Engineering, Process Performance Qualification (PPQ) and commercial batches as part of the manufacturing team.

Routine Operations

• Complete all required 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.

About you:

• Degree or Diploma in a related Engineering or Science discipline

• >5 years of relevant working experience in the biopharmaceutical industry.

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

• Applicant for Process Manufacturing Biotechnologist should have a good knowledge and experience in either upstream or downstream unit operations.

• Applicant for Central Manufacturing Services (CMS)Biotechnologist should have a good knowledge and interest to work with fully digital and automated systems will be preferred. Systems including but not limited to Enterprise Resource Systems (ERP), Autonomous Guided Vehicles (AGVs), robotics, and conveyor systems.

• Self-starter and independent worker who can operate and perform in cross functional teams.

• Possess analytical and critical thinking skills with the ability to problem solve and navigate through complexity and ambiguity.

• Able to work in fast paced and dynamic conditions with tight timelines.

• Good technical writing skills.

• Team player

• Working hours during the initial Project Phase – work office hours (weekdays) with hybrid work locations from both Sanofi Tuas Site Office and home.

• Working hours beyond the Project Phase – 12 hours rotating shift (including day/night, and weekends) on site to support production activities.