Scientist II, Serology

Company: LGC
Location: Milford
Posted on: November 17, 2022

Job Description:

LGC is a leading, global life science tools company, providing mission-critical components and solutions for high-growth application areas across human healthcare and applied market segments. Our high-quality product portfolio comprises mission-critical tools for genomic analysis and quality assurance applications, which are typically embedded and recurring within our customers' products and workflows and are valued for their performance, quality, and range.
Our tools play a key role in customer workflows from discovery applications through to commercial manufacture and enable its customers to: bring new diagnostics and therapies to market; progress research and development; optimize food production; and continuously monitor and enhance the quality of food, the environment and consumer products.
LGC's 175+ years of scientific heritage, combined with a track record of innovation and value-enhancing acquisitions, has enabled the company to build its product portfolio and expertise, and develop deep relationships with customers, industry partners and the global scientific community. Join us and help us achieve our mission of Science for a Safer World! Job PurposeThe Scientist II, New Product Development - LCMS position will work with and report to the Director Product Development, Biochemistry. This role will support LGC Clinical Diagnostics purpose of advancing the understanding of LCMS within the clinical diagnostics space. As a scientist II, this leader will work with cross functional teams to bring innovative, multiplexed LCMS quality control materials to market to serve the diagnostics community. This Scientist II will provide clearly articulated timelines and priorities and be a contributor to team's workflow as needed to meet internal and external customer needs. Key Responsibilities

• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals
• Technical expertise as a key scientific resource for LC-MS applications related to new product development
• Technical project leader/subject matter expert for multiple projects related to LC-MS new product development.
• Organize projects and data using Excel, Word, PowerPoint. Use specialized software as appropriate.
• Interact with clients when applicable to provide technical project updates, review and evaluate data, write reports and protocols
• Aids in coordinating all aspects of LC-MS LDT method development and validation when applicable
• Draft new product design control documentation to meet ISO13485 and applicable CE/IVD requirements.
• Ensure LC-MS equipment is monitored for appropriate operation within set parameters where applicable. Aid in new LC-MS equipment validation where applicable and aid in writing standard operating procedures (SOPs) for use and maintenance.
• Develop processes for manufacture and testing of new LC-MS products. Draft SOPs for new processes and perform method validations as appropriate.
• Evaluate alternative raw materials, develop purchasing specifications and plan for project raw material requirements by maintaining appropriate inventory of reagents.
  Knowledge, Experience, and Technical Skills
  • Critical thinker who can analyze data and respond quickly to manage product development projects.
  • Technical capabilities with analytical expertise in LDT method development for LC-MS a plus
  • Experience with LCMS-MS
  • Strong knowledge of extraction techniques with biological matrices
  • This position requires an individual who possesses a strong work ethic and has excellent communication, organization, and time-management skills.
  • He/she must have strong computational skills, good record keeping abilities, and experience using PC based programs (MS Word, Excel, etc) as part of daily routines.
  • This work demands attention to technical detail and documentation according to procedures, and the maintenance of an accurate and comprehensive laboratory notebook is required. The laboratory work requires the use of personal protective equipment and strict adherence to safety protocols, as well as regular proficiency testing and performance of shared laboratory and other duties as assigned.
    Education and/or Experience
    • Master's degree in natural science with a preference for Chemistry or Biochemistry.
    • A minimum of five years' experience in technical operations or equivalent lab experience
    • Experience with product/process development and manufacture in a cGMP environment.
    • Familiarity with diagnostic and medical device requirements including ISO 13485.
    • Strong experience in DOE (design of experiments) and Statistics are preferred.
    • Experience with LC-MS required.
    • Experience with LC-MS LDTs strongly preferred.
    • Familiarity with LC-MS Clinical diagnostic test methods, platforms, and data analysis required.
      What we offer (US based employees):
      • Competitive compensation with strong bonus program
      • Comprehensive medical, dental, and vision benefits for employees and dependents
      • FSA/HSA Pre-tax savings plans for health care, childcare, and elder care
      • Deductible Buffer Insurance and Critical Illness Insurance
      • 401(k) retirement plan with matching employer contribution
      • Company-paid short- and long- term disability, life insurance, and employee assistance program
      • Flexible work options
      • Pet Insurance for our furry friends
      • Enhanced Parental leave of 8 additional weeks
      • PTO that begins immediately
      • Town Hall monthly meeting onsite/virtual, Cheer program where employees are recognized for outstanding work, Companywide social events, frequent catered lunches and much more!

Keywords: LGC, Milford , Scientist II, Serology, Other , Milford, Connecticut