Job Description

OraSure Technologies Inc. (OTI) empowers the global community to improve health and wellness by providing access to accurate, essential information. Our ability to positively affect change is powered by the innovative tools and diagnostics we deliver to the market.

Together with its wholly owned subsidiaries, OTI provides its customers with end-to-end solutions.

It's first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and Hepatitis C (HCV) on the OraQuick platform; sample self-collection and stabilization products for molecular applications; and oral fluid laboratory tests for detecting various drugs of abuse.

Overview

Here at the OTI our 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.

This role at OraSure Technologies is a unique and dynamic position that combines the responsibilities of both a Program Manager and a Project Manager. This role is responsible for managing multiple, diverse product development projects through prioritization, timelines, resources, budget, and deliverables. The position demands a proven leader who can manage complex projects from inception to close-out, collaborate across diverse cross-functional teams, and navigate complex strategies and project interactions.

You will oversee multiple project teams, ensuring that program goals are reached, and organizational objectives are met. You will develop and maintain program initiatives, manage budgets, and produce program reports for managers and stakeholders.
Additionally, you will apply product life cycle methodology to the New Product Introduction (NPI) process, plan and define project scope, coordinate with Product Managers, manage project resources, and ensure that project deliverables meet required regulations, standards, and specifications.

This role ensures that all goods manufactured and services provided by the Company meet user and customer needs, conform to the quality procedures and requirements of the Company, and meet applicable US and international regulations and standards.

The position is hybrid or remote, with occasional on-site work at the Bethlehem, PA, Newton, MA, Ottawa (Canada), Cambridge, UK, and/or Oxford, UK facilities. Preference will be given to candidates located within commuting distance of Bethlehem, Newton, or Ottawa offices.
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Snapshot of Responsibilities

Oversee multiple project teams, ensuring program goals are reached. Strategize, implement, and maintain program initiatives that adhere to organizational objectives. Develop program assessment protocols for evaluation and improvement. Maintain organizational standards of satisfaction, quality, and performance. Manage budget and funding channels for maximum productivity. Work closely with project sponsors, cross-functional teams, to develop the scope, deliverables, required resources, work plan, budget, and timing for new initiatives. Identify key requirements for cross-functional teams and external vendors. Develop and manage budget for projects and be accountable for delivering against established business goals/objectives. Analyze, evaluate, and overcome program risks, and produce program reports for managers and stakeholders. Apply product life cycle methodology to the New Product Introduction (NPI) process in collaboration with the project team. Plan and define project scope, including establishing objectives, deliverables, and timelines. Coordinate with Product Managers and lead cross-functional teams in planning, execution, and communication of key project deliverables. Manage project resources, including allocation and management of team members, budget, and equipment. Identify potential project risks and develop strategies to mitigate them. Keep stakeholders informed and engaged throughout the project. Lead and motivate the project team to achieve project goals. Ensure that project deliverables meet the required regulations, standards, and specifications. Monitor project progress as well as maintain clear and regular communication with cross-functional groups and stakeholders. Provide updates to supervisors regarding project status and design control requirements. Present program status to senior management for review and approval. Facilitate problem-solving and decision-making processes while addressing and resolving project-related issues in a timely and efficient manner. Track and control project expenses to stay within budget. Maintain comprehensive project documentation for future reference and audits. Generate and maintain project management and design control documents, including plans, design control/product realization deliverables tracking, schedules, resourcing, timelines, and budgets. Ensure product development timeline and deliverables meet commercial needs for market launch, including product claims, market research, and KOL studies/communication. Ensure compliance with relevant regulations and quality standards, including but not limited to U.S. Code of Federal Regulations for Medical Devices, European In Vitro Diagnostic Directives/Regulation, EN/ISO 13485, IEC 62304, and IEC 62366. Manage and track product changes. Ensure core team personnel understand and comply with the requirements of New Product Development, Design Control, and changes to existing products as applied to the Company's products. Support compilation of design history files and contents for technical files, design dossiers, FDA and European submission documents, and/or any other related documents/reports, ensuring timely submissions to meet Company products and regulatory requirements, and compliance with all approved licenses. Participate in the investigation of failures and execution of continuous improvement initiatives. Write and maintain procedures relating to product development, the preparation and presentation of reports, data, and Key Performance Indicators for management reviews. Maintain current knowledge of related industry trends and regulations as well as integrate lessons learned. Comply with the Company's Quality Systems along with other obligations deemed appropriate for a Project Manager.
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What You Bring

Minimum of 8 years' experience in vitro diagnostics (preferred), medical devices industry. Demonstrable track record in product development with increasing responsibility leading to management of complex projects and launching new capabilities to market. Experience with regulatory submissions (e.g., 510(k), PMA). A completed 3 or 4 year college diploma or university degree in one of the following areas: Quality, Science (chemistry, biology, or medical technology), or Engineering. Desired experience in product development, for example as a contributing engineer or scientist. Experience with design control processes for medical devices and related processes. Deep understanding of project management methodologies and techniques with practical experience using project management tools (i.e., Microsoft Project). Proven ability to drive project governance and hold cross-functional teams and project leaders accountable for meeting established objectives. Strong analytical and problem-solving skills with the capability to simplify complex issues and mitigate accordingly. Competency with internal and external audit processes. Proficient use of basic computer software (Microsoft Office preferred). Excellent verbal and written communication skills with presentation capabilities. Project Management Professional (PMP) certification considered an asset Ability to travel based on business need (less than 15% of the time).

The base salary range for this full-time position is $109,000 - $185,000 USD. In addition to base salary this position is eligible for participation in our annual bonus program. The range displayed on the job posting reflects the minimum and maximum base salary for the position, based on our defined salary pay ranges. Our ranges are broad to account for differences in roles, performance, experience, skillsets, education and business needs and individual pay is determined by a variety of factors. We offer a comprehensive Total Rewards package, as noted below.

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:Tiered Medical PPO, EPO, Vision and Dental coverage Disability and Life Insurance Benefits Generous 401K plan and company-matching contributions Highly competitive 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 the OTI family of companies 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 club and 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 rebecca.zeleney@dnagenotek.com. 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 applicant's individual accessibility needs.