R&D Scientist II

MMQCI•Saco, ME

1d•Onsite

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. The role involves designing, developing, and validating 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. This includes preparing reports and documentation for quality audits. The scientist will conduct complex laboratory procedures and analyses using manual molecular biology techniques and instrumentation, identify experimental issues, and troubleshoot problems. They will also design optimal sequences and engineer complex DNA constructs using public databases, collaborate with other departments, organize and analyze data, interpret results, and recommend future experiments. Establishing, validating, performing, and interpreting molecular clinical assays, including multiple amplification technologies and sequence analysis using alignment software like Geneious Prime, is also a key responsibility. The role requires maintaining awareness of current literature, contributing to technical writing for publications and presentations, and potentially attending scientific conferences to identify candidates for the product pipeline, network, learn about new equipment, assess competition, and represent the company. The scientist may also work with pathogens in a BSL2 environment.

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
Must be able to stand for several hours and lift approximately 30 lbs

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
May attend scientific conferences to identify clinically relevant candidates for the product pipeline, network with other scientists, learn about new equipment by speaking with vendors, assess competition, and, represent the scientific face of MMQCI
May work with pathogens in a BSL2 environment