TITLE: Program Coordinator

TYPE: Direct Hire

LOCATION: King of Prussia, PA

ONSITE/REMOTE/HYBRID: Hybrid (3 days onsite, 2 days remote)

We are seeking a detail-oriented Program Coordinator to support the execution of product development initiatives within our growing diagnostics division. This role will work across multiple functions to coordinate the timely development and transfer of immunoassay-based products onto automated platforms. The successful candidate will collaborate closely with project managers, scientists, regulatory teams, and manufacturing partners to ensure strategic goals and timelines are consistently met.

This position offers the opportunity to work in a dynamic and fast-paced environment where innovation and precision drive meaningful results in the development of diagnostic solutions.

MAIN RESPONSIBILITIES

• Coordinate cross-functional efforts to support timely execution of development project milestones.
• Manage and maintain timelines, resource alignment, and overall progress tracking across multiple initiatives.
• Partner with stakeholders in Product Development, Analytical Development, Clinical Affairs, Regulatory Affairs, and Operations.
• Support the transition of newly developed immunoassays into manufacturing, ensuring all documentation and regulatory requirements are satisfied.
• Assist with preparation of reports, project updates, and presentations for internal and external stakeholders.
• Maintain detailed and organized project records and communicate risks, delays, or changes proactively.
• Monitor and ensure compliance with all internal policies and relevant regulatory standards.
• Utilize project management software tools to track and report on project status and performance metrics.
• Identify and escalate critical project risks, offering recommendations for mitigation.
• Perform additional duties as assigned.

QUALIFICATIONS

• Bachelor’s or Master’s degree in Biological Sciences, Engineering, or a related field required.
• Minimum of 5 years of laboratory or product development experience within diagnostics or pharmaceuticals.
• At least 3 years of project coordination or project management experience in a regulated environment.
• Strong understanding of immunoassay technologies and diagnostic product lifecycle is desirable.
• Prior exposure to manufacturing and quality control operations is preferred.
• Excellent written and verbal communication skills with the ability to present technical information effectively.
• High attention to detail and ability to manage multiple concurrent priorities.
• Proficient in Microsoft Office and project management tools (e.g., Microsoft Project, Smartsheet).
• Proven ability to collaborate across departments and influence outcomes without direct authority.
• Strong organizational skills and ability to thrive in a deadline-driven environment.

EOE STATEMENT

We are an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.