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Sr. Product Development Specialist (Genetic Testing, Rare Disease)- Remote, USA

Remote: 
Full Remote
Contract: 
Salary: 
150 - 150K yearly
Experience: 
Senior (5-10 years)
Work from: 
California (USA), United States

Offer summary

Qualifications:

Bachelor’s degree in Genetics or related field, 5+ years of product development experience, Strong understanding of genetic testing industry, Proficiency in product lifecycle management, Master’s or PhD preferred.

Key responsabilities:

  • Oversee product development lifecycle compliance
  • Collaborate with cross-functional teams on product concepts
  • Analyze competitor products and research literature
  • Write and edit technical documents for development
  • Present project updates to stakeholders
Ambry Genetics logo
Ambry Genetics Biotech: Biology + Technology SME https://www.ambrygen.com/
501 - 1000 Employees
See more Ambry Genetics offers

Job description

Compensation: $120-150k per year. You are eligible to a Short-Term Incentive Plan with the target at 10% of your annual earnings, terms and conditions apply. 
 
Sr. Product Development Specialist (Genetic Testing, Rare Disease)- Remote, USA
  
The Sr. Product Development Scientist is responsible for the design and implementation of new products in Ambry’s rare disease portfolio. This role may also assist with improvements/updates to existing products. The position is highly cross-functional, working across departments to refine business and product requirements to provide the test development framework in order to complete the product development phases.
 

Essential Functions 

  • 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 & M arketing 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
Qualifications 
 
  • 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

 

About Us:  

Ambry Genetics Corporation is a CAP-accredited and CLIA-licensed molecular genetics laboratory based in Aliso Viejo, California. We are a genetics-based healthcare company that is dedicated to open scientific exchange so we can work together to understand and treat all human disease faster.

At Ambry, everyone is welcome. A career at Ambry Genetics is a chance to be part of a dynamic company that aims to improve health by understanding the relationships between genetics and human disease. We earned our reputation as industry leaders by responsibly introducing cutting-edge genetic testing solutions and continually sharing what we learn with the global scientific community.

At Ambry you will be learning, challenging yourself, and having fun while collaborating with teammates through the open exchange of ideas.  Our outstanding benefits program includes medical, dental, vision, 401k with a 4% employer match, FSA, paid sick leave and generous paid time off (PTO) program. You can learn more about the benefits here. Ambry Genetics is an Equal Opportunity Employer (EOE) and we maintain a drug-free work environment.

The Company believes in second chance employment.  Qualified applicants with arrest or conviction history will be considered regardless of their arrest or conviction history, consistent with local laws such as Los Angeles County Fair Chance Ordinance and the California Fair Chance Act.  You do not need to disclose your criminal history or participate in a background check until a conditional job offer is made to you. After making a conditional offer and running a background check, if the Company is concerned about conviction that is directly related to the job, you will be given the chance to explain the circumstances surrounding the conviction, provide mitigating evidence, or challenge the accuracy of the background report. For the purpose of the above job description, “Essential Functions” are “Material Job Duties”.

Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.

All qualified applicants will receive consideration for employment without regard to race (and traits historically associated with race, including, but not limited to hair texture and protective hairstyles such as braids, locks, and twists), color, creed, religion, sex, sexual orientation, gender identity, gender expression (including transgender status), national origin, ancestry, age, marital status or protected veteran status and will not be discriminated against on the basis of disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. If you have a disability or special need that requires accommodation, please contact us at careers@ambrygen.com

Ambry does not accept unsolicited resumes from individual recruiters, third party recruiting agencies, outside recruiters or firms without an executed contract in place. We are not responsible for any fees related to resumes that are unsolicited or are received by Ambry. Such resumes will be deemed the sole property of Ambry and will be processed accordingly. 

PRIVACY NOTICES 

To review Ambry’s Privacy Notice, Click here: https://www.ambrygen.com/legal/privacy-policy

To review the California privacy notice, click hereCalifornia Privacy Notice | Ambry Genetics

To review the UKG privacy notice, click here: California Privacy Notice | UKG

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Required profile

Experience

Level of experience: Senior (5-10 years)
Industry :
Biotech: Biology + Technology
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Adaptability
  • Analytical Skills
  • Collaboration
  • Problem Solving
  • Verbal Communication Skills
  • Social Skills

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