Associate Director

SENIOR MANAGER/ASSOCIATE DIRECTOR, ASSAY DEVELOPMENT

REPORTS TO: SVP, Application

POSITION SUMMARY

At EXOKĒRYX, we are committed to creating cutting-edge platforms and tests that leverage extracellular vesicles, the body’s concentrated, information-dense cellular communication system.  Toward this end, we are growing the Assay Development team. This Senior Manager or Associate Director position is a key hands-on and managerial role, requiring an individual capable of designing, conducting, and interpreting, and presenting the results of development-oriented experiments. This individual is an analytical, hard-working team player with demonstrable experience in assay development in a biotech setting under design control. She/he tackles novel assays and information methodically to make measurable progress and enjoys gaining a deep understanding of the system(s) being studied/developed. She/he functions as the technical lead of projects, driving the planning, design, and timely completion of key project deliverables. This individual has excellent communication skills, a goal-oriented mentality, and a strong sense of ownership and drive to meet project goals and timelines.

ESSENTIAL DUTIES

• Lead the conception, planning/design, development, and validation of biochemistry- and molecular biology-based assays
• Serve as a subject matter expert on the landscape of relevant test methodologies and on the inherent properties of relevant biological analytes
• Identify and establish crucial technical capabilities to support company and product goals
• Provide deep technical expertise for analytical test methodologies:

immunochemistry and molecular biology methods (e.g., ELISAs, Westerns, flow, qPCR)

statistics-driven experimental design and analysis

• Anticipate technical challenges and proactively design workflows/experiments to mitigate technical risks, taking ownership of results, interpretations, next steps, and timing
• Systematically drive the characterization, optimization, and verification/validation of test method performance characteristics
• Lead data analysis, interpretation of results, and communication of findings in a professional and knowledgeable manner to a variety of audiences, technical and non-technical, internally and externally facing
• Lead cross-functional collaboration across the organization, proactively engaging other teams to promote project success (Engineering, Quality, Commercial, Manufacturing)
• Generate high-quality technical reports and slides to effectively communicate experimentation and findings to a variety of audiences
• Serve as assay technical lead in risk management, product development design review, and product development phase gate activities
• Author QMS-compliant documentation
• Other duties as assigned

EDUCATION/EXPERIENCE/SKILLS

Minimum Qualifications

• Senior Manager: Bachelor’s or Master’s degree in Biology, Biochemistry, Molecular Biology, Bioengineering, or a closely-related field, with a minimum of 7 years of industry experience in the development of biochemistry- and molecular biology-based assays; or PhD in Biology, Biochemistry, Bioengineering, or closely-related field, with a minimum of 5 year of industry experience in the development of biochemistry- and molecular biology-based assays
• Associate Director: Bachelor’s or Master’s degree in Biology, Biochemistry, Molecular Biology, Bioengineering, or a closely-related field, with a minimum of 9 years of industry experience in the development of biochemistry- and molecular biology-based assays; or PhD in Biology, Biochemistry, Bioengineering, or closely-related field, with a minimum of 7 years of industry experience in the development of biochemistry- and molecular biology-based assays
• Demonstrated success managing and mentoring direct reports
• Demonstrated expertise using statistical analysis and software for data-driven decision making
• Demonstrated expertise in design of experiments, design control, process control, variance analysis, measurement system analysis
• Excellent communication skills
• Strong sense of ownership and urgency over project deliverables and technical success

Preferred Qualifications

• Expertise with extracellular vesicles
• Expertise with cell culture and mammalian expression systems
• Expertise using JMP statistical software or the equivalent
• Expertise developing medical devices in compliance with ISO 13485, ISO 15189, ISO 9001, GLP, CAP/CLIA, 21 CFR 820, or the like
• Experience working with human blood/plasma specimens

 Contact careers@exokeryx.com to apply.