Ambry Genetics · 5 hours ago
Sr. Product Development Specialist (Genetic Testing, Rare Disease)- Remote, USA
United States
Full-time
Remote
Senior Level
$120K/yr - $150K/yr
5+ years exp
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Hiring Manager
Noah Kaufman
Insider Connection @Ambry Genetics
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Responsibilities
Oversee the product development lifecycle, ensuring compliance with regulatory standards (e.g., CLIA, CAP, NYS, FDA)
Work closely with clinical, regulatory, marketing, and support teams to gather insights, refine product offerings, and develop effective go-to-market strategies
Collaborate in development and validation testing processes to ensure products meet quality standards and regulatory requirements
Bring product concepts through product development phases working in collaboration with counterparts in regulatory, Product Management & Marketing and Project Management Organization.
Identify key requirements for products or updates that fit internal and client needs
Formulate and establish product design in collaboration with cross-functional teams to ensure product and project success
Present findings and project updates to core team and other stakeholder groups
Assess and analyze competitor products
Analyze and stay abreast of medical/scientific literature and standard of care guidelines regarding genetic testing and methodologies
Write and/or edit technical documents that summarize development work
Assist with and contribute to regulatory development framework and submissions
Review and edit scientific content in related marketing collateral
Other duties as assigned
Qualification
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Required
Bachelor’s degree in Genetics, Biotechnology, Molecular Biology, or a related field or equivalent professional experience
5+ years of experience in product development or management within the genetic testing or biotechnology industry Genetic testing laboratory experience desired, proven track record of successfully launching genetic testing products from concept to market.
Must have a strong understanding of the current state of genetic testing industry, in addition to a broad knowledge of the field of clinical genetics
Strong understanding of product lifecycle management, regulatory requirements, and agile methodologies.
Excellent communication and interpersonal skills, both written and oral
Exceptional analytical and problem-solving skills
Work very well independently, be able to collaborate and communicate with internal team members both remote and on-site
Adaptable to a dynamic and fast-paced environment
Preferred
Master’s or PhD preferred
Familiarity with Clinical and Laboratory Standards Institute (CLSI) standards
Experience with FDA IVD product development plans and submissions
Proficiency in project management tools and software
Benefits
Short-Term Incentive Plan with the target at 10% of your annual earnings, terms and conditions apply.
Medical
Dental
Vision
401k with a 4% employer match
FSA
Paid sick leave
Generous paid time off (PTO) program
Company
Ambry Genetics
Ambry leads in clinical genetic diagnostics and genetics software solutions.
501-1,000 employees
H1B Sponsorship
Ambry Genetics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2022 (3)
2021 (6)
2020 (8)
Funding
Current Stage
Late StageTotal Funding
unknown2024-11-06Acquired· undefined
2017-10-19Series Unknown· undefined
Leadership Team
Tom Schoenherr
Chief Executive Officer (CEO)
Mike Martinson
Chief Financial Officer
Recent News
Modern Healthcare
2024-11-06
2024-05-24
Company data provided by crunchbase
