Senior Manager, Molecular Innovation - Adaptive Biotechnologies : Job Details

At Adaptive, we're Powering the Age of Immune Medicine. Our goal is to harness the power of the adaptive immune system to transform the way diseases are diagnosed and treated.

As an Adapter, you'll have the opportunity to make a difference in people's lives. With Adaptive, you'll create a career highlight through collaboration with bright, curious colleagues working at the apex of innovation and application.

It's time for your next chapter. Discover your story with Adaptive.

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 an 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

ALERT: Malicious groups posing as Adaptive employees have recently used fraudulent email aliases to extend employment offers, provide fake documents, and request sensitive personal and financial information. Legitimate Adaptive employment opportunities are initiated through our careers page and extended after multiple interviews with verified employees. Adaptive does not ask new hires to purchase anything out-of-pocket, including home office supplies and equipment.

Interested in this position, but don't meet all the requirements? Adaptive is committed to building diverse, equitable, and inclusive teams across our organization. Please consider applying even if your experience doesn't match all the qualifications; you may be the exact candidate we're searching for!

Adaptive is not currently sponsoring candidates requiring work authorization support for this position.

Adaptive's posted compensation information includes a base salary (or hourly rate) range and summary of other available total compensation. The base salary range represents a minimum-to-maximum salary (or hourly rate) available to candidates upon extension of offer. Base salary is thoughtfully considered upon offer and is determined through multiple evaluation checks throughout the interview process, including: a candidate's ability to meet minimum qualifications (skills/experience/education), a candidate's ability to thoughtfully address preferred qualifications, current market conditions, and internal pay equity. Listed base salary is exclusive of bonus, commission, equity, differential pay, benefits, and other incentives.

Adaptive Biotechnologies is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.