Work Your Magic with us!
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.
Your Role
Reporting into the Manager / Laboratory Manager-Biosafety Testing. Laboratory Scientist– Biosafety Testing is responsible to perform a wide variety of routine tasks to support GMP operations and primarily focusses on Biosafety testing. Responsibilities include performing assays required to characterize product, lot release of products, general laboratory housekeeping, and preparation of reagents, stock control and general equipment maintenance.
The Laboratory Scientist is responsible for training and / or mentoring junior members of lab personnel. The post holder may also have some Responsible Scientist 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
- Works within the Biosafety laboratory following Standard Operating Procedures and relevant compliance regulations to ensure routine and custom studies are completed on time and accurately recorded to meet appropriate scientific and GMP regulatory standards
- Trains and mentors newer / junior members of lab personnel
- Author of laboratory protocols, Standard Operating Procedures (SOPs) and workbooks for projects and raise and progress Change Control for new service introduction
- Actively reviews and improves working documents (Protocols, Technical Specifications, SOP’s, batch records and workbooks) via document control
- Performs peer review of raw data records as required
- Performs assay validations according to the relevant protocols
- Maintains SOP’s, laboratory books, forms ensuring removal of superseded versions (where appropriate)
- Responsible for maintenance of stock control in the laboratory and order consumables and reagents through i-procurement
- Carries out housekeeping and equipment checks as appropriate to ensure that laboratory compliance is maintained at all times
- Proactively implements improvements to laboratory processes and procedures to improve efficiencies and reduce waste
- Ensure lab is at constant audit readiness state
- Participate in internal Quality Audit or regulatory audit if required
- Maintains a clean, tidy and safe work environment at all times
- Acts as Responsible Scientist or Study Director for routine assays and as such holds responsibility for the overall conduct of GMP study
- Works with Lab Manager, Team Lead 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
- Ensures a safe and healthy work environment at all times by not only complying with but actively embracing health and safety policies and procedures, ensuring the safety of yourself and others within the workplace
Who You Are
- Minimum Degree in Biological Sciences or higher qualification in 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
- Demonstratable 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
Additional Local Needs
- 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 celebrate all dimensions of diversity and believe that it 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 our diverse team!
