Position Overview
The Sr Manager, Product Development will lead an assay development team within the MRD R&D organization. The Sr. Manager will lead technical development activities for new IVD, CE-IVD, and LDT assays and improvements and expansion of existing assays (clonoSEQ). The Sr. Manager will be responsible for following Adaptive’s Product Development Process (PDP) and ensuring that projects are developed under design control. This leadership role will interact with cross functional development teams (Core Teams) and work with all levels of employees to oversee the product development process from Concept to Launch. The Sr. Manager will be responsible for documenting development work in the Design History Files and Risk Management Files that support the MRD business’s regulated assays; they will establish the technical documentation necessary to ensure compliance with applicable regulations such as FDA 21 CFR Part 820, ISO 13485, ISO:14971 and other standards and regulatory requirements.
Key Responsibilities and Essential Functions
- Manages a team of scientists responsible for development and expansion of Adaptive’s portfolio of clinical diagnostic MRD assays. Guides decision-making and provides scientific mentorship for their team. Manages team members performance and career development.
- SME and technical project lead for development of gDNA and cfDNA NGS assays as well as the exploration of other analytes and technology platforms. Responsibilities include development and optimization of reagents, assay workflow, and QC criteria. Provides innovative and creative solutions to resolve complicated technical challenges.
- Partners closely with other development teams (e.g., CompBio and software), to analyze and interpret complex data sets and results.
- Represents R&D on cross-functional project teams. Responsible for defining the scope of R&D activities: experimental plans, defining key development deliverables, milestones, dependencies, and overseeing their execution by coordinating cross-functional activities.
- Leads design transfer activities. Coordinates handoff of design specifications and processes to manufacturing and/or CLIA laboratory. Partners with these teams during process development by providing technical expertise.
- Responsible for the development of design history files to comply with FDA's regulations and ISO standards
- Responsible for design control activities, authoring and reviewing design control deliverables (e.g. requirements, specifications) and risk management documents (e.g. FMEA) to support IVD products.
- Provide status reports and timeline updates in collaboration with project management for communication to Upper Management.
Position Requirements (Education, Experience, Other)
Required
- Advanced degree (PhD) in molecular genetics, immunology, bioengineering, or related field and 5+ years of experience (MS with 8+ years, BS with 12+) in assay research and development
- 2+ years of supervisory experience
- Demonstrated expertise in assay development and bench work. Solid understanding of multiplex PCR and NGS technology, sequencing data analysis and statistical analysis. Experience designing and executing projects that answer critical questions.
- Demonstrated ability to collaborate with team members across the organization and work on cross functional teams. Ability to communicate, present, and discuss scientific findings with staff members across the organization at all levels from Research Assistants to Executive Team.
- Excellent technical scientific writing, communication, and organizational skills are required.
Preferred
- Experience developing IVD or CLIA assays under design control including design transfer, verification, and validation activities necessary for diagnostic product commercialization. Experience developing products to meet the following regulatory requirements: FDA CFR 820, ISO 13485, ISO 14971, and/or CLIA/CAP, CLEP. Familiarity with CLSI guidelines.
- Experience mentoring direct reports and/or leading technical teams.
- Familiarity with basic statistical analysis: sampling plans, power analysis, statistical analysis software (e.g., JMP, R)
- Understand project management methodologies and capable to provide leadership for projects
Working Conditions
Work is performed in and office environment but may occasionally be required to work in a laboratory handling human biological specimens. Must also have flexibility and willingness to work more than standard hours when necessary, including nights & weekends, etc.
Compensation
Salary Range: $127,400 - $191,200
Other compensation elements include:
- equity grant
- bonus eligible