Job description
LGC’s Clinical Diagnostics Division develops and manufactures a comprehensive portfolio of catalog and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.
Our operating entities include SeraCare Life Sciences and Maine Standards Company, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials) and the Native Antigen Company, which is a manufacturer and supplier of viral antigens. Our 300+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland, USA, and an ISO 9001-accredited facility in Oxford, UK.
Each day, our world-class staff, scientific expertise, operational efficiency and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.
Job Purpose
The Research Associate I position will advance LGC Clinical Diagnostics Division purpose of understanding disease by supporting the manufacture of precision diagnostic products. Support includes independently performing routine and non-routine applications of cellular/molecular genetic technology to quantitate and manipulate genetic material all under GLP/GMP.
Key Responsibilities
- Formulate bulks using production batch records.
- Perform general molecular techniques such as cloning, plasmid purification, gel-electrophoresis, RNA transcription, and bacterial culturing.
- Perform nucleic acid analyses (RNA/DNA integrity analysis, real time qPCR, digital PCR) and analyze results.
- Filling product vials and assembly of kits.
- Maintenance of different cell lines in cell culture (viral or bacterial) and manufacture of cell based products.
- Organize projects and data using Excel, Word, PowerPoint and a document control system.
- Work in collaboration with the Quality Assurance group to fulfill Quality Management Goals and proactively address problems under an ISO quality system.
- Monitor, maintain and calibrate laboratory equipment as needed
- Plan for raw material requirements by maintaining appropriate inventory of reagents and ordering reagents as needed through an ERP system (SAP).
- Maintain a clean and safe lab environment.
- Material consumption using SAP system.
- Cycle count and inventory management.
Knowledge, Experience and Technical Skills
- Critical thinker who can analyze date and respond quickly to manage manufacturing projects.
- Ability to manage multiple projects.
- Capability of working with multiple departments to achieve manufacturing goals.
- Ability to work independently.
- Strong organizational skills.
- Engaged and committed team professional who is committed to generating quality products.
- Professional work ethic driven by manufacturing time-lines.
- Passion for continuous improvement.
- Independent thinker and self-learner.
Education and/or Experience
- A Bachelor’s degree in Biochemistry or Molecular Biology or a related field with a minimum of one year of related experience is preferred.
- A Master’s degree is preferred.
- Experience in manipulating and quantitating DNA/RNA, including DNA/RNA Purification, PCR (endpoint, real time PCR or digital PCR), DNA/RNA electrophoresis.
- Software experience: Excel, Word and Powerpoint. Proficient with Word for the use of writing/editing SOPs.
- Demonstrated ability to follow SOPs for the purpose of manufacturing products.
- Experience in cell culture preferred.
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