Senior Research and Development Associate

SENIOR RESEARCH & DEVELOPMENT ASSOCIATE

Microbiologics, a leader in providing external controls for molecular diagnostic assays is seeking to expand its Product Development Team with the addition of an experienced Senior R&D Associate trained in molecular biology and assay diagnostics. The Senior Associate will design, lead, perform and report on experiments using microbiology and molecular techniques leading to new products or process improvements in an FDA-QSR and ISO13485 compliant organization. The ideal candidate will have experience in product commercialization, expert knowledge of concepts (such as nucleic acid extraction, real time PCR and Digital PCR), and a high level of scientific creativity and technical proficiency.

The candidate will:

• Design, propose and lead technical development, prototype optimization, design validation and transfer of new products to other functional units (Production/QC).
• Perform analytical studies required to demonstrate technical feasibility of quality control material for complex assays, develop/implement verification studies (LoD, LOQ, FMEA, Reproducibility), analyze data using statistical tools and author technical reports.
• Write and review new SOPs as well as update existing department SOPs, as necessary.
• Ensure proper care in the use and maintenance of equipment and supplies; promotes continuous improvement of workplace safety and environmental practices.
• Create and present Formal Design Review presentations at key milestones.
• Communicate with customers regarding results and custom specifications when necessary.
• Support investigations of CAPA and customer complaints as needed.
• Anticipate, test and resolve issues pertaining to routine & non-routine product quality, usage and performance

The essential requirements of the job include:

• Bachelor’s degree in related field with 6+ years of related work experience OR Master’s degree in related field with 0-2 years of related work experience.
• Flexibility to work independently and with technicians to solve complex problems, optimization of multiplex control materials, create new controls/methods/testing procedures.
• Ability to design primer and probes, perform nucleic acid isolation, multiplexed real-time PCR, ddPCR optimization experiments.
• Strong knowledge and practical experience with various public databases for retrieving publications or nucleotide sequences.
• Ability to perform gene cloning and expression.
• Experience with IVD product development and design controls in a GMP environment.
• Ability to work in a laboratory and with BSL-2 organisms.
• Experience with statistical analysis techniques.
• Organized self-starter with excellent problem solving and analytical skills.

 A preferred candidate would have:

• Experience in developing molecular diagnostic assays/quality control products for clinical laboratory platforms like the Gene Xpert, BD Onclarity, BioFire Torch, Roche COBAS.
• Proven track record of collaborating with cross functional teams to support development and transfer activities (R&D, Production, Regulatory and Quality).
• Knowledge of analytical test methods based CLSI & FDA guidelines