renegade. bio: Director Of Molecular Biology

renegade. bio: Director Of Molecular Biology

renegade. bio

Scientific / QA
CA United States

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Are you a renegade? Renegades are scientists, entrepreneurs, and neighborhood organizers, mobilizing as a public profit company for everybody’s well being. Communities. Households. Folks. We’re dedicated to creating diagnostic testing extra accessible and simple to make use of for everybody.Place SummaryThe Director of Molecular Biology willhave oversight of the Subsequent Technology Sequencing laboratory inside the Analysis and Growth group. On this position, the director will be sure that pattern consumption and logistics,preparation, high quality management, library preparation and evaluation is correctly carried out, thatapplicable regulatory (CAP/CLIA, HIPAA, and security) requirements are met.The Director of Molecular Biology will likely be accountable for making certain that the laboratory implements high-throughput in vitro diagnostic testing (IVD) and provision of NGS knowledge for inside and exterior reporting, whereas constantly creating and / or enhancing normal working procedures and offering correct and dependable affected person take a look at outcomes.The position of the Director of Molecular Biology is to steer the supply of ongoing R& D help to an outlined renegade.Bio portfolio of merchandise by way of the administration and growth of a group of individuals. The analysis focus will embody the event of novel diagnostics derived from small/microRNA, mRNA, complete exome sequencing in addition to quantitative PCR. The Director of Molecular Biology will lead and handle a group below the supervision of the VP of Product Growth and supply R& D upkeep help tothe portfolio of renegade.Bio Lab Developed Assessments and IVDs.Important Duties and ResponsibilitiesThe important features embody, however usually are not restricted to the next:Lead a group accountable for offering quantitative PCR and subsequent technology sequencing help inside the R& D portfolio of renegade.Bio merchandise enabling protection, income development and compliance to the manufacturers precept.Handle an operation that complies totally with required CLIA, CAP and regulatory necessities.Interface with key companions and stakeholders (Provide, compliance, advertising, amenities, IT) each day.Answerable for the administration of all technical issues regarding the initiatives for which he/she has accountability.Work with RB regulatory groups or regulatory consultants and/or companies to make sure our merchandise adjust to nationwide, business and inside requirements.Help all regulatory authority questions and be sure that product licenses are managed according to the required requirements.Write and submit grant proposals for brand spanking new non-dilutive funding alternatives from obtainable funding alternatives similar to SBIR, BARDA, White Home, DARPA, or others.Develop a bioinformatics pipeline to investigate complicated units of organic knowledge generated by multi-omics applied sciences together with deep studying/machine studying to conduct systems-biology research through integrating multi-omics human in addition to environmental knowledge.Minimal {Qualifications} (Information, Abilities, and Talents)Educated to a Doctorate Diploma stage (Chemistry, pharmacy, chemical engineering or different related science).Minimal 6 years R& D Healthcare expertise with a confirmed observe document of supply of laboratory developed assessments and IVD product growth, derived from genetic materials.Confirmed observe document as a frontrunner in planning, prioritization and implementing initiatives in addition to figuring out prices financial savings and drawback fixing.Confirmed observe document in lively collaboration with R& D and non-R&D features.Expertise with recruitment, administration and growth of Analysis personnel.Expertise managing a group concerned in molecular diagnostic product growth.Expertise with early levels of in vitro diagnostic (IVD) and laboratory diagnostic take a look at (LDT) product growth by way of the invention of biomarkers, growth and assay validation of molecular diagnostics required.Information of GLP and related regulatory necessities for diagnostics together with CAP/CLIA and FDA.Expertise working inside a fluid, high-growth and remotely-managed surroundings.Working information and expertise with venture planning software program (e.G. Asana, Project365, Google Suite and so on.).Sturdy group participant capable of collaborate cross functionally with a number of departments.Glorious communication (written and verbal), analytical and multi-tasking expertise.Means to affect groups in a matrix administration surroundings.Artistic and impartial thinker with an innate drawback fixing talents.Formal Expertise with NGS and PCR methodology.Expertise with samples derived from human topics is most popular.Be aware: All provides of employment are contingent upon clear outcomes of an intensive legal background test. ShiftsM-F 9am-5pmJob Kind: FT ExemptCompensationSalary: $160-170KBenefits: Well being, Imaginative and prescient, and Dental120 hours PTO; 401k

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renegade. bio: Director Of Molecular Biology

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