Director of Molecular Biology

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Position Summary

The Director of Molecular Biology will have oversight of the Next Generation Sequencing laboratory within the Research and Development team. In this role, the director will ensure that sample intake and logistics, preparation, quality control, library preparation and analysis is properly performed, that applicable regulatory (CAP/CLIA, HIPAA, and safety) standards are met. The Director of Molecular Biology will be responsible for ensuring that the laboratory implements high-throughput in vitro diagnostic testing (IVD) and provision of NGS data for internal and external reporting, while consistently developing and / or improving standard operating procedures and providing accurate and reliable patient test results. The role of the Director of Molecular Biology is to lead the provision of ongoing R&D support to a defined renegade.bio portfolio of products through the management and development of a team of people. The research focus will encompass the development of novel diagnostics derived from small/microRNA, mRNA, whole exome sequencing as well as quantitative PCR. The Director of Molecular Biology will lead and manage a team under the supervision of the VP of Product Development and provide R&D maintenance support to the portfolio of renegade.bio Lab Developed Tests and IVDs.

Essential Duties and Responsibilities

The essential functions include, but are not limited to the following:

• Lead a team responsible for providing quantitative PCR and next generation sequencing support within the R&D portfolio of renegade.bio products enabling defense, revenue growth and compliance to the brands principle.
• Manage an operation that complies fully with required CLIA, CAP and regulatory requirements.
• Interface with key partners and stakeholders (Supply, compliance, marketing, facilities, IT) on a daily basis.
• Responsible for the management of all technical matters relating to the projects for which he/she has accountability.
• Work with RB regulatory teams or regulatory consultants and/or agencies to ensure our products comply with national, industry and internal standards.
• Support all regulatory authority questions and ensure that product licenses are managed in line with the required standards.
• Write and submit grant proposals for new non-dilutive funding opportunities from available funding opportunities such as SBIR, BARDA, White House, DARPA, or others.
• Develop a bioinformatics pipeline to analyze complex sets of biological data generated by multi-omics technologies including deep learning/machine learning to conduct systems-biology studies via integrating multi-omics human as well as environmental data.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Educated to a Doctorate Degree level (Chemistry, pharmacy, chemical engineering or other relevant science).
• Minimum 6 years R&D Healthcare experience with a proven track record of delivery of laboratory developed tests and IVD product development, derived from genetic material.
• Proven track record as a leader in planning, prioritization and implementing projects as well as identifying costs savings and problem solving.
• Proven track record in active collaboration with R&D and non-R&D functions.
• Experience with recruitment, management and development of Research personnel.
• Experience managing a team involved in molecular diagnostic product development.
• Experience with early stages of in vitro diagnostic (IVD) and laboratory diagnostic test (LDT) product development through the discovery of biomarkers, development and assay validation of molecular diagnostics required.
• Knowledge of GLP and relevant regulatory requirements for diagnostics including CAP/CLIA and FDA.
• Experience working within a fluid, high-growth and remotely-managed environment.
• Working knowledge and experience with project planning software (e.g. Asana, Project365, Google Suite etc.).
• Strong team player able to collaborate cross functionally with multiple departments.
• Excellent communication (written and verbal), analytical and multi-tasking skills.
• Ability to influence teams in a matrix management environment.
• Creative and independent thinker with an innate problem solving abilities.
• Formal Experience with NGS and PCR methodology.
• Experience with samples derived from human subjects is preferred.

• Note: All offers of employment are contingent upon clear results of a thorough criminal background check.

Shifts

M-F 9am-5pm

Job Type: FT Exempt

Compensation

Salary: $160-170K

Benefits: Health, Vision, and Dental

120 hours PTO; 401k