Laboratory Scientist

Job description

Overview
Laboratory Scientist – Biosafety Testing is responsible to perform a wide variety of routine tasks to support GMP operations and primarily focuses on Molecular Biology, NGS, Virology and Cell Culture work related to Biosafety Testing.

Responsibilities include performing PCR-based assays, NGS testing or Cell Culture/Virology assays in Biosafety laboratories to characterize product, maintenance of cell culture detector cell lines, preparing and qualifying 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 for client and regulatory audit observations through the Contract Testing Services Integrated Quality System (Trackwise)
Lead and ensure deviation and 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 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 GMP standards
Perform assay transfers 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Maintain SOPs, laboratory books, and forms, ensuring outdated versions are removed promptly; review and improve working documents through document control processes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 in a timely manner
Raise and progress deviation and 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
Minimum Degree in Biological Sciences or higher qualification in a relevant scientific subject
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
Demonstrable experience in implementing projects to set-up/improve lab processes/systems
Good oral and written communication skills in English
Capability on problem solving, customer service and planning skills
ERP experience is an asset (Oracle / SAP/ LIMS/ Trackwise)
Proficient in Microsoft programs (Word, Excel, PowerPoint, etc)
Adheres to safety SOPs and follows safe work practices
Always ensures a safe and healthy work environment
Team player, proactive and willing to take ownership
Strong Aseptic Technique and cell culture skills (for Virology focus)
Strong molecular biology skills and NGS applications (for NGS focus)
Flexibility to work overtime or shifts to cover business spikes/needs when necessary
What we offer
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.

We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology.

We are committed to creating access and opportunities for all to develop and grow at your own pace.

Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress.


Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
Seniority level
Associate
Employment type
Full-time
Job function
Production and Manufacturing
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