Director of Assay Development MBio Diagnostics of Boulder, CO (www.mbiodx.com) is seeking to fill the position of Director of Assay Development. MBio is rapidly growing technology company focused on next generation products for medical diagnostics, food safety, and environmental applications. The position will lead the assay development group, and report to the Chief Operating Officer. The candidate who will fill this position will join the management team of MBio, and s/he will help guide the growth of this dynamic organization. MBio has secured multiple partnerships in several industries, leading to a number of assay development projects. The ideal candidate will have the scientific and management skills to excel in this rapidly developing organization. Personal Attributes & Expectations • An individual with honesty, integrity, and perseverance • The ability to work within the fast-paced teams of a small and growing company • Proven ability to lead a team to goals not previously believed possible Program Management • Ability to manage multiple parallel partnerships o Excellent communication in both technical and business contexts o Ability to align a partnership with MBio’s business priorities • Capability to coordinate with all stakeholders, including: o Customers o Assay team o Company management o Peers in other departments Technical The Director of Assay Development should have a background that will ideally include: • General biological assay development, including immunoassays and nucleic acid tests • A thorough knowledge of available reagents, along with the means and vendors to generate proprietary molecules • Detailed knowledge of antibodies and other binding molecules, including o Monoclonal antibody manufacturing o Polyclonal antibody selection and purification o Recombinant antibody approaches o Binding epitopes, isotypes, sandwich assay design o Bioconjugation chemistry approaches o Oligonucleotide hybridization • Reference methods including ELISA, rapid tests, Luminex®, etc. Personnel Management The candidate will have responsibility for MBio’s growing team of assay development scientists which includes a mix of education and experience levels. • Leading teams, especially in the context of diverse priorities • Overseeing program managers running their own teams • Hiring and developing talent within the assay team Business & Legal • MBio works with biological reagent suppliers. The ideal candidate will have demonstrated expertise with reagent licensing and definition of terms • Working knowledge of biological reagent intellectual property landscape, particularly freedom-to-operate analyses and patenting Quality / Regulatory • We prefer candidates with regulated in vitro diagnostics (IVD) product experience, including ISO 13485, FDA QSR, and IVDD/IVDR. • If candidates don’t have direct IVD experience, then medical device, life sciences tools, and pharma background will also be considered (in that relative order) • Demonstrated skill working under a Quality Management System Applicant must have authorization to work in the U.S. Resumes must be accompanied by a cover letter explaining how the applicant meets the job requirements and desired skills. Please email cover letter and resumes to firstname.lastname@example.org with applicant name and the job title listing in the subject line. No phone calls, please. MBio Diagnostics, Inc. is an Equal Opportunity Employer.