Director, Assay Development
Director, Assay Development
Posted on :
09-08-2025
Employer Active
1 Vacancy
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Job Description
Together with its wholly owned subsidiaries OTIprovides its customers with end-to-end solutions.
Overview
Here atOTIour innovative sampling tools and diagnostics unlock access to accurate essential information that advances global health and well-being. Our products include molecular sampling kits for the genome and microbiome and rapid diagnostics for infectious disease.
Leads team(s) responsible for development of Molecular Diagnostics products and the technologies that enable them. Responsible for team organization and performance including prioritization planning supervising and communicating the work of a team of scientists and technicians.
Snapshot of Responsibilities:
- Manages multi-tiered functional organization responsible for development of molecular diagnostic assays and associated enabling technologies
- Works with executive management to prioritize projects and assign resources communicating resource gaps as necessary
- Works with technical leaders within functional organization to outline development optimization and design verification plans
- Collaborates with outside groups/companies as needed.
- May participate in cross-functional product development core teams
- Supervises the design evaluation and optimization of experiments to develop safe and effective products.
- Applies biochemical molecular and biophysical techniques to develop measurable parameters to assure reproducibility and stability in product manufacturing
- Designs experiments evaluates data communicates results to others and determines subsequent course of action consistent with project and company goals.
- Develops technical staff in the design of experiments and proper use of controls and laboratory notebook keeping.
- Provides expert technical advice on competitor products new products and current scientific concepts that may lead to new products. Should maintain ongoing surveillance of marketing scientific and patent literature to stay abreast of new developments and products that may impact OraSure Technologies Inc. business.
- Prepares and presents papers at scientific meetings and/or publishes in scientific journals
- Writes invention disclosures describing patentable inventions arising from work performed
- Determines needs for clinical specimens for product development and participates in the planning of analytical studies
- Assures compliance with all pertinent safety and regulatory policies.
What You Bring:
- Past experience in successful development of molecular diagnostics products released for sale in US and/or international markets
- Demonstrable experience in developing in vitro diagnostic products in the area of infectious disease
- Demonstrable skill in developing clinical sample preparation methods that achieve product design goals under design control
- Demonstrable technical skill and experience in the design and optimization molecular (preferably isothermal) in vitro diagnostic assays
- Familiarity with FDA Quality Systems regulations
- Excellent written and oral communication skills
- Willing to work at the bench to assist in teaching technical skills to subordinates.
- Ph.D. with 12 years of industry experience preferably leading in vitro diagnostic assay development teams
- Previous experience in leading technical teams responsible for the development of products or components of in vitro diagnostic assays including assays for infectious disease agents
- Previous experience participating in cross-functional product development teams and investigations.
- Expertise in optimization of formulations and production processes conduct of Design of Experiments (DOEs) and evaluation of product performance
OTI encourages applications from all qualified candidates who represent the full diversity of the communities in which we operate. We apply a rigorous consistent and equitable standard to the assessment of all candidates regardless of race color national origin sex (including pregnancy) sexual orientation gender identity disability status age religion veteran status or any other protected characteristic. We are committed to creating a diverse and inclusive environment where all employees are welcomed and belong.
What we have to offer:
- Private Insurance which includes supplemental health coverage and dental coverage
- Life Insurance Benefits
- Pension scheme
- Paid time off
- Maternity Leave and Parental Leave Coverage
- Employee Referral Program you may be eligible for a cash bonus if your referrals are hired
- Employee Assistance Program
- Employee Service Recognition
- Job-related Training Programs
- Ability to participate in Teams Committees Events and Clubs
- Depending on the role you may be eligible to work in a hybrid environment or fully remotely
- Free Onsite Parking
Please note the above applies to full-time permanent positions.
Culture People & Community
OTI recognizes that the long-term health of our business is directly connected to the health of the planet local communities and OTI employees.
- LIVE IT Committee committed to creating an environment that embodies our values
- All Means U: Employee Committee on Belonging hosts various events across all company locations such as monthly book cluband mentorship program
- Wellness Committee empowers colleagues to make critical decisions to improve and protect health
- Sustainability Committee aims to minimize impact on the environment
- Social Committee who organize and run events for both remote and onsite employees to create connection and community
At OTI we have a clear vision; cultivate an environment of equal employment opportunity where we do not tolerate discrimination or allow the harassment of employees or applicants on the basis of sex gender identity sexual orientation race color religious creed national origin physical or mental disability protected Veteran status or any other characteristic protected by law with regard to any employment practices.
OTI aims to create and foster workplaces that reflects and contributes to the global communities in which we do business and the customers and partners we serve. This includes all communities impacted by our corporate presence. As part of this commitment OTI and its subsidiaries will ensure employees and applicants are provided reasonable accommodation per request. If you require disability-related accommodation during the recruitment process please contact Rebecca Zeleney at @. OTI will consult with all applicants who request disability-related accommodation during the recruitment process to ensure that the accommodation provided takes into account the applicants individual accessibility needs.
Required Experience:
Director
Employment Type
Full-Time
Key Skills
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