Scientist II

Company 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 arein vitrodiagnostics (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 Description

The Scientist II helps advance LGC CDx’s 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 biology technology to quantify and manipulate genetic material.

• Assist in leading the R&D Teams to promote a high performance, innovative culture.
• Mentor junior scientists within R&D and other departments to promote their independence, problem solving skills and technical expertise.
• Develop reference materials for clinical diagnostics. Understanding how our customers’ assays work is a critical part of this process. This requires reading and assessing product literature and scientific research articles.
• Manage and mentor research technicians within the R&D team and mentor others outside of the department.
• Perform general molecular techniques such as nucleic acid purification, gel-electrophoresis, RNA transcription, cell culture, and bacterial culture.
• Perform nucleic acid analysis (RNA/DNA integrity analysis, real time qPCR, digital PCR) and analyze results.
• Design new biosynthetic constructs or primers/probes for use in new products.
• Develop processes for manufacture and testing of new products. Draft SOPs for new processes and perform method validations as appropriate.
• Plan and execute experiments and tasks as assigned according to the timelines and ensure documentation meets GLP/GMP requirements.
• Culture cells using aseptic techniques. Introduce nucleic acids into cultured cells.
• Organize projects and data using Excel, Word, PowerPoint and a document control system (EtQ).
• 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 investigate abnormal results.
• 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.
• Maintain accurate records in laboratory notebooks.
• Transfer designs to other individuals and groups in R&D and manufacturing, including training and writing standard operating procedures (SOPs) and design history records (DHRs).
• As necessary, validate new equipment, and ensuring that equipment is operating properly.
• Initiate and perform process improvement studies and update SOPs as required.
• Work in collaboration with the Quality Assurance group to fulfil Quality Management Goals and proactively address problems under an ISO quality system.
• Evaluate alternative reagents, develop purchasing specifications and plan for project raw material requirements by maintaining appropriate inventory of reagents.
  
  

Qualifications

Minimum Qualifications:

• Bachelor’s degree in Molecular Biology, Cell Biology, Genetics or similar discipline with at least 7 years of relevant experience in clinical testing, diagnostics development, or similar.
• Master’s degree in Molecular Biology, Cell Biology, Genetics or similar discipline with at least 2 years of relevant experience in clinical testing, diagnostics development, or similar.
• Knowledge of diagnostics for clinical genomics, including for oncology, non-invasive prenatal testing, and inherited disease.
• Deep technical knowledge of molecular methods including PCR and NGS as used in diagnostic applications. Technical knowledge of RNA and DNA extraction and manipulation, as well as synthetic construct designs.
• Excellent communication skills required.
• Organizational and Project Management skills required.
  
  

Preferred Qualifications:

• PhD in Molecular Biology, Cell Biology, Genetics or similar discipline.
• 1 year of management experience leading teams of technicians and scientists.
• Work in a regulated medical environment under a Quality Management System is preferred.
• Understanding of design control processes.
• Experience with NGS systems, digital PCR systems, Agilent Tapestation, Qubit and other nucleic acid analysis instruments.
• Working knowledge of relevant regulations including IVDR 2017/745-746 Regulation and ISO 14971:2019.
  
  

Additional Information

LGC recognizes benefits are key resources as you navigate your well-being journey. We’re pleased to offer comprehensive programs that are focused on supporting our employees and families’ well-being. Most of our benefit programs are effective the 1st of the month following hire date.

• Comprehensive medical, dental, and vision benefits for employees and dependents
• FSA/HSA Pre-tax savings plans for health care, childcare, and elder care
• 401(k) retirement plan with matching employer contribution
• 100% paid parental leave, up to 8 weeks
• 100% paid Caregiver leave, up to 3 weeks
• Paid Holidays, which include floating days and a holiday shutdown in December
• Company paid Basic Life / Accidental Death
• Company paid Short & Long-Term Disability
• Company paid Employee Assistance Program
• Health Savings Accounts
• Flexible Spending Accounts (Healthcare and Dependent Care)
• Identity Theft & Protection
• Legal Services
• Pet Insurance
• Voluntary Worksite Benefits
• Tuition Reimbursement
• Employee Referral Program
  
  

The annual base pay range for this FLSA exempt role is:

Minimum: $77,760

Maximum: $116,640

The pay range represents the low and high end of the current salary range for the Maryland-based position. The range provided is a general guideline and not a guarantee of compensation or salary. A new hire or new to position’s salary is typically evaluated between the minimum and midpoint of the salary range. Factors considered in extending an offer include, but are not limited to, relevant education, experience, knowledge, skills, abilities, internal equity, and alignment with market data.

Additionally, this position is eligible for a discretionary bonus program. Participation in the bonus program is not guaranteed, and bonuses are awarded at the discretion of the company based on individual and company performance.

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or maternity, religion, or belief. Short listing, interviewing and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership.

For more information about LGC, please visit our website www.lgcgroup.com

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