SENIOR MANAGER/ASSOCIATE DIRECTOR, ASSAY DEVELOPMENT

REPORTS TO: Head of Assay Development 

STATUS: Full Time  

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 and leadership for: 

• immunochemistry methods (e.g., ELISAs, flow cytometry) 
• molecular biology methods (nucleic acid manipulation) 
• fluorescence detection systems (e.g., plate readers, flow cytometers, 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, Operations, and Regulatory) 
• Author QMS-compliant documentation 
• 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 
• 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 in fluorescence-based detection methodologies (nucleic acids and proteins) 
• Demonstrated expertise using statistical analysis and software for experimental 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 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 amber.murray@exokeryx.com to apply.