Principal/Senior Scientist – R&D

Title: Principal/Senior Scientist – R&D

Location: on site in Irvine, California

Salary: Base ~$165k USD plus package

The Client: JBAndrews is partnering with a pioneer in Companion & Contract Diagnostics, that develops NGS and qPCR based assays

Principal/Senior Scientist

Primary Job description

This R & D team is seeking a motivated, collaborative, and highly skilled Senior Scientist with passion for developing and validating NGS/qPCR based molecular diagnostics assays for implementation in CLIA lab and/or for FDA approval.

The candidate is expected to lead various aspects of preclinical development and validation of NGS and qPCR based molecular diagnostics assays for clinical and/or research applications. He / She will work closely with our internal colleagues and external collaborators to efficiently progress early-stage assay development through to IND filing. This position will report directly to the Director of Research & Development and will play a critical role in supporting the development and implementation of novel assays to the clinic.

The successful candidate has extensive experience in a combination of skills including all aspects NGS/qPCR based molecular diagnostics, development, and optimization of a variety of assays (primarily molecular). The candidate is expected to demonstrate in-depth understanding of current research and technological developments in molecular biology applied to qPCR and NGS. Prior experience in managing direct reports is preferred.

We seek a passionate, self-driven, and dedicated individual who takes initiative, contributes to innovative ideas, independently designs /executes experiments, and performs critical data analysis. In addition they will be a hands-on resource for other team members providing in-depth technical advice and troubleshooting suggestions as needed.

An ideal candidate is well organized, pays attention to details, works well in a team setting, shows maturity, a sense of urgency and responsibility to complete tasks meticulously on time. He/she will independently design and execute experiments, mentor Ph. D level scientists, collaborate with other cross functional teams to support research projects under the supervision of R & D Director. Passion for excellence and innovation as well as experience with CAP/CLIA regulations and working with regulated assays highly preferred. Working knowledge of ISO 13485, GLP, and FDA regulations for IVD is critical.

Primary Responsibilities:

• Lead planning, design, and execution of experiments related to development and characterization of customer requirements for assay design in coordination with the R & D director.
• Analyze, and report complex data to cross functional teams in a clear and concise manner
• Mentor and train scientific staff on technical skills required to effectively perform experiments and to facilitate progression of projects (qPCR, NGS, Multicolor flow cytometry)
• Manage multiple research projects simultaneously with the R & D team and collaborate with other departments (Clinical, Bioinformatics, Regulatory, Quality, Manufacturing), as necessary.
• Contribute to various preclinical projects within R & D and those required by clients through in-depth scientific knowledge and demonstrated experience in analytical methods used in the molecular biology field.
• Manage the work of multiple late preclinical stage clients effectively to drive projects to completion
• Work closely with our internal colleagues to efficiently progress early-stage products
• Provide support for drafting client reports, patents, SOPs, and peer-reviewed scientific publications
• Provide scientific and technical support to direct reports and other team members (Research Scientists and Research Associates)
• Maintain precise laboratory notebooks, electronic records following high standards of data quality and integrity.
• Proactively identify and supervise solutions to challenges, risks, and changes that could lead to project delays or cost changes
• Prepare scientific/technical reports, summaries, protocols, etc, and present them to internal and external stakeholders.
• Constantly improvise research strategies and adopt technologies to stay updated in the field.
• Reports to: Director of R&D

Knowledge, Skills & Abilities:

• Extensive experience in a variety of molecular techniques (molecular, western blotting, immunoprecipitation, qPCR, flow cytometry, ELISA, NGS assays)
• Demonstrated understanding of scientific and technological basis of methods used in molecular biology to exercise technical judgment and troubleshoot projects
• Experience in working with different mammalian cells lines and primary human cells (adherent tumor cells, PBMCs, primary T, NK, and macrophages)
• Highly skilled in multi-parameter flow cytometric analysis of immune cells from blood products.
• Must be able to independently design assays, acquire, analyze, and interpret data
• Competency in Data analysis software (ie. Excel, GraphPad Prism, and FlowJo)
• In depth scientific and technical understanding of molecular biology techniques and application to genomic analysis.
• Demonstrated ability to independently design, plan and troubleshoot experiments, interpret results, and present to the R&D team and external clients.
• Self-motivated and creative, able to work within a team and collaborate with external teams as needed to accomplish project objectives and deliverables.
• Possess ability to identify problems early, technically trouble-shoot and resolve challenges in early development and preclinical validation.
• Understands the importance of data integrity to enable a smooth transition of discovery research to manufacture and clinical trials.
• Familiarity with FDA regulation of molecular assays and products, IND-filing, GLP/GMP, CAP CLIA process is required.
• Ability to stay organized, prioritize tasks, manage time efficiently, and provide creative solutions to meet program needs
• Excellent interpersonal, verbal, and written communication skills
• Comfortable working in a fast-paced environment and flexible to adjust workload based upon changing priorities
• Team player / Building Relationships / Problem Solver
• Customer focus, decisive decision making, active listening

Education & Professional Experience:

• Ph. D in the field of Immunology, Cell biology, Virology or Cancer biology or related life science discipline with 8-10 years of relevant research experience in molecular biology.
• 3+ years experience of mentoring research teams in molecular biological assay design and development is required.
• Prior industry research experience in designing analyzing and implementing molecular biology assays
• Strong industry research experience in molecular biology potentially evidenced by high caliber publications in peer-reviewed journals is desirable

Working Conditions:

• Laboratory environment – required to work with different samples types including blood products, saliva, urine, tumor cell lines, bacteria, etc
• Must wear PPE due to safety requirements in designated lab areas
• May be required to work in controlled or clean room environments
• Expected to work safely and effectively when working alone or working with others