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BioGX · 1 month ago

Research and Development Scientist

Hoover, AL

Full-time

Onsite

Mid, Senior Level

2+ years exp

BioGX is a company focused on developing innovative diagnostic solutions. The Research and Development Scientist will perform laboratory research to develop multiplex PCR tests and oversee R&D associates while ensuring compliance with quality management systems.

BiotechnologyManufacturing

Responsibilities

Perform laboratory research to develop multiplex PCR tests for a variety of real-time PCR platforms

Involves use of both automated and non-automated PCR instruments

Includes planning experiments, scientific literature research to evaluate and select target sequences of interest, analysis of data, documentation and summarization of research, and transfer of developed tests

Includes preparation of protocols, reports, and other documented information that meet QMS requirements

Uses chemistry, biochemistry, and molecular biology knowledge to solve the range of development problems associated with genetic tests for the presence of specific DNA and RNA sequences

Supervises R&D Associates, works in laboratory, participates on product transfer teams

Carries out design of experiments (D.O.E.) studies needed to establish robust PCR-based genetic test performance and uses experimental results to develop raw material requirements, product performance specifications, product packaging requirements, stability characteristics, and product’s manufacturing release test criteria

Carries out feasibility and development experiments, protocols, procedures, using Good Documentation Practices and clear and professional report writing supporting product development for timely completion of project(s)

Maintains current knowledge of competitive technologies, new principles and theories relevant to product R&D and commercialization

May train, motivate, and develop R&D staff

Document experimental protocols, results of studies and process design/development history to meet QMS requirements

Supervise one or more Research Associates / Associate Scientists depending upon project scope

Qualification

PCR-based diagnostic developmentDNARNA processingISO design controlReal-Time qPCRBSL2 proceduresProject planningTechnical writingSupervisory experienceMicrosoft OfficeTeam collaborationConflict resolutionCommunication skills

Required

Experience of nucleic acid, PCR-based diagnostic test product development experience

Experienced with DNA and RNA sample processing and sample stabilization procedures

Experienced with BSL2 procedures and safe handling of human blood and fluids to obtain purified nucleic acids for use in test procedures

Direct experience with ISO design control procedures and participation in development, verification, validation stages of technology transfer into a GMP manufacturing unit

Well organized and efficient with handling multiple tasks at the same time

Technician supervisory experience

Experienced with short, intermediate and longer term project planning and clinical research

Fluent in the use of Microsoft Word, Excel, PowerPoint

Excellent written and verbal communication skills

Work seamlessly in a team environment, with the ability to relate to both highly educated and unskilled team members

Ability to handle and resolve conflicts and work under stressful conditions

The ideal candidate will have a Ph.D. or M.S (plus 2 to 5 years experience) degree in Microbiology, Molecular Biology or related field