Laboratory Scientist

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Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

**Who We Are**

We are a leading science and technology company. Its life science business offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.

**Your Role**

Laboratory Scientist - Biosafety Testing is responsible to perform a wide variety of routine tasks to support GMP operations and primarily focusses on Molecular Biology, NGS, Virology and Cell Culture work related to Biosafety Testing. Responsibilities include performing either PCR-based assays, NGS testing or Cell Culture/Virology assays in Biosafety laboratories which required to characterize product, maintenance of cell culture detector cell lines, preparing and qualifying of reagents, monitoring stock levels, and conducting general equipment maintenance to sustain seamless workflow and optimal performance of laboratory equipment.

The Laboratory Scientist is responsible for training and / or mentoring junior members of lab personnel. The post holder may also have some Responsible Scientist or Study Director responsibilities for routine GMP studies. They will also be responsible for root cause investigations, providing scientific and technical support of the studies performed in the laboratory.

**What You Do**
- Acts as Responsible Scientist or Study Director for routine assays and as such hold responsibility for the overall conduct of GMP studies
- Works with Lab Manager or Scientist on testing schedule for laboratory personnel
- Writes and reviews assay risk assessments related to area of operational expertise
- Ensures trending spreadsheets are completed timely for all studies in accordance with relevant SOP
- Responsible on client and regulatory audit observations through the Contract Testing Services Integrated Quality System (Trackwise)
- Lead and ensure deviation and Corrective or Preventative Action (CAPA) records closed in a timely manner
- Raise and progress Change Control for new service, testing, assay validation introduction
- Works within the Molecular Biology, NGS, Virology, and Cell Culture laboratories following Standard Operating Procedures and compliance regulations.
- Adherence to Standard Operating Procedures (SOPs) and Compliance Regulations: Ensure all work is carried out according to established protocols and regulatory standards.
- Ensure zero overdue LMS records, timely complete training required to perform the assay or task.
- Complete routine and custom studies on time, maintaining accurate records that meet scientific and Good Manufacturing Practice (GMP) standards.
- Perform assays transfer following relevant protocols as required.
- Maintain SOPs, laboratory books, and forms, ensuring outdated versions are removed promptly. Review and improve working documents through document control processes.
- Manage stock levels, order consumables, and handle procurement through designated systems.
- Conduct housekeeping, equipment checks, and environmental and personnel monitoring to ensure compliance and safety.
- Maintain a clean, tidy, and safe work environment, adhering to health and safety policies and procedures.
- Train and mentor newer or junior members of the lab personnel.
- Participate in internal quality audits and regulatory audits as required.
- Maintain a constant state of readiness for audits across all laboratory areas.
- Author laboratory protocols, SOPs, and workbooks for projects.
- Conduct peer reviews of raw data records and ensure accurate data management practices on a timely manner.
- Raise and progress deviation and Corrective and Preventive Action (CAPA) records promptly.
- Proactively identify and implement improvements to laboratory processes and procedures to enhance efficiency and reduce waste.
- Participate in site or global initiatives

**Who You Are**
- 4 plus years of working experience in biologics or biopharmaceutical industry
- 3 plus years of working experience in a regulated environment (GLP/GMP or equivalent)
- 2 plus years of working experience in specific area of expertise (molecular biology, virology, microbiology/mycoplasma) with demonstrated ability to trouble-shoot
- Quality mindset and good understanding of GMP/GLP
- Demonstratable experience in implementing project