Drive cross-functional programs that bring new clinical products to market and enhance existing ones, with a strong focus on Design Control and New Product Introduction in a regulated environment.
Partner across teams—including R&D, business, operations, and engineering—to define goals, milestones, and plans that balance resources, risks, and priorities.
Lead all phases of product development, from early concept through commercialization and post-launch, ensuring alignment, transparency, and momentum.
Develop and maintain key program documentation, such as project plans, protocols, and reports, to keep teams informed and accountable.
Track progress and communicate results through clear, data-driven reports and regular updates to senior leadership.
Champion Design Control excellence, managing gate reviews, design freezes, technical assessments, change control, and regulatory deliverables.
Facilitate productive team meetings that drive decisions, surface and mitigate risks, and maintain focus on program objectives.
Guide trade-off and risk decisions to balance technical, business, and regulatory considerations and challenge assumptions while adapting to evolving priorities.
Foster collaboration and problem-solving, helping teams overcome challenges, resolve conflicts, and deliver high-quality results on time.
Coordinate joint development efforts with external partners to ensure seamless integration and progress.
Manage up to 3 dynamic programs simultaneously, anticipating challenges and maintaining progress in a fast-paced environment.

Requirements

Bachelor’s degree in Biology, Molecular Biology, Biochemistry, Bioinformatics, Computer Science, or a related technical discipline (or equivalent experience) required; Master’s degree or higher preferred.
Minimum 3 years of program management experience in biotech, life sciences, or another regulated technical industry.
Project management certification or training (e.g., PMP or equivalent) preferred.
Background in research, assay development, systems engineering, lab operations, or software development is highly desirable.
Familiarity with laboratory informatics systems and processes such as LIMS, sample accessioning, sequencing pipelines, and results reporting preferred.
Minimum 3 years of project budget management experience preferred.
Experience with software development lifecycle principles, data architecture patterns (e.g., SOA), and agile tools (e.g., Jira, GitLab) a plus.

Benefits

Annual performance incentive bonus
Long-term equity awards
Comprehensive health benefits (medical, dental, vision)
401(k) with company match
Generous paid time off and company holidays
Additional wellness and work-life benefits

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

program managementproject managementdesign controlnew product introductiondata architecture patternssoftware development lifecycleassay developmentsystems engineeringlab operationsbudget management

Soft skills

collaborationproblem-solvingcommunicationleadershiprisk managementdecision-makingadaptabilitytransparencyaccountabilityfacilitation

Certifications

PMPproject management certification