Research Associate II - Antibody Purification and Conjugation
LGC Clinical Diagnostics team 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 Maine Standards Company, SeraCare Life Sciences, and Technopath Clinical Diagnostics, 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 400+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), 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:Advance Clinical Diagnostics purpose of understanding disease by supporting the research and development of new precision diagnostic products. Support includes independently performing routine and non-routine applications of cellular/molecular genetic technology to quantitate and manipulate genetic material.
Perform various manufacturing functions related to antibody conjugation and purification.
Draft and review production documents and technical reports.
Organize projects and data using Excel, Word, PowerPoint and a document control system (ETQ).
Work with supervisor to plan and execute new projects as assigned according to the timelines and ensure documentation meets GLP/GMP requirements.
Record test results and data records, seek appropriate approval and file according to established procedures.
Maintain, calibrate and operate equipment according to established protocols. Monitor equipment for appropriate operation within set parameters and refer abnormal results to lab management.
Work in collaboration with the Quality Assurance group to fulfil Quality Management Goals and proactively address problems under an ISO quality system.
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.
Knowledge, Experience and Technical Skills
Critical thinker who can analyze date and respond quickly to manage projects.
Ability to manage and complete projects as assigned.
Capability of working with multiple departments to achieve project related goals.
Ability to work independently with minimal supervision.
Strong organizational skills
Engaged and committed team professional who is committed for product integrity.
Passion for continuous improvement
Can work on diverse projects and is willing to reprioritize them as needed
Collaborates effectively with others
Independent thinker and self-learner
Education and/or Experience
A recent master's degree in Biochemistry or Molecular Biology or a related field within the last year.
Experience in purification and conjugation preferred
Experience in microbiology preferred
Experience in writing and executing protocols is preferred.
Software experience: SAP preferred.
Analytic skills: Perform preliminary data interpretation/analysis. Follow SOPs.
The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requires prolonged sitting and working at a computer monitor. Repetitive motion using a keyboard for long periods of time. May occasionally be required to lift and move material weighing up to 10 lbs.
Requires moving between lab spaces and standing/sitting at lab benches. Requires repetitive manual pipetting.
The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Seracare Life Sciences Inc