R&D Scientist II

MMQCISaco, ME

About The Position

MMQCI is seeking an eager scientist to provide support for new product development and validation of quality control products for clinical molecular diagnostic tests.

Requirements

  • B.A. or B.S. in Biology, Chemistry, or a related field with a minimum of 3–5 years of experience in a relevant discipline, or a Ph.D. with 1–2 years of relevant experience
  • Strong knowledge of general molecular biology techniques, including cloning, sequencing, amplification, and electrophoresis
  • Highly organized with strong attention to detail
  • Ability to perform laboratory procedures accurately and reproducibly
  • Works efficiently while maintaining high-quality standards
  • Strong work ethic and sense of ownership
  • Excellent verbal and written communication skills, with the ability to present results and collaborate with team members at all levels
  • Demonstrated ability to innovate and contribute new ideas

Nice To Haves

  • Previous product development experience or experience working in a GMP regulated environment preferred

Responsibilities

  • Design, develop and validate new quality control products for molecular diagnostic tests under the guidance of R&D leadership, in compliance with cGMP, FDA 21 CFR 820, ISO 13485, and MMQCI’s Quality System; prepare reports and documentation to support quality audits
  • Conduct complex laboratory procedures and analyses using a range of manual molecular biology techniques and instrumentation; identify experimental issues and troubleshoot problems using established knowledge and skills
  • Design optimal sequences and engineer complex DNA constructs using public databases to support the development of control products
  • Collaborate and communicate regularly with other departments to ensure timely delivery of high-quality products
  • Organize and analyze data, interpret results, and recommend future experiments and product improvements
  • Establish, validate, perform, and interpret molecular clinical assays, including multiple amplification technologies and detailed sequence analysis using alignment software such as Geneious Prime
  • Maintain awareness of current literature related to molecular techniques and clinical laboratory quality control practices
  • Contribute to technical writing for abstracts, posters, and scientific manuscripts for publication or presentation at technical conferences

Benefits

  • Medical, dental, and vision insurance
  • 401(k)
  • Profit Sharing Plan
  • Vacation
  • Holidays
  • Sick leave
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