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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in program management within regulated industries, focusing on product development, project planning, and compliance with FDA Design Controls. Proficient in managing cross-functional teams and driving projects from concept through commercialization while ensuring effective communication and risk management.
Highest-signal resume keywords
Program Management ExperienceProject Management CertificationFDA Design Controls UnderstandingLaboratory Informatics Systems FamiliaritySoftware Development Lifecycle Principles
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project PlanningRisk ManagementData Architecture PatternsGantt Chart CreationBudget ManagementTechnical AssessmentsChange ControlRegulatory DeliverablesDesign Control Gate ReviewsAssay Development
Soft Skills
Exceptional CommunicationInterpersonal SkillsStrong OrganizationResilienceAdaptabilityTime ManagementMultitaskingProblem-SolvingCollaboration
Tools & Technologies
SmartSheetJiraGitLabLIMSSequencing PipelinesData-Driven ReportingProject Management ToolsAgile ToolsLaboratory Operations SystemsCross-Functional Collaboration Tools
Certifications & Qualifications
Project Management CertificationPMP Certification
Industry Keywords
BiotechLife SciencesRegulated Technical IndustryFDA RegulationsISO 13485ISO 15189EU IVDRCybersecurity RegulationsClinical ProductsNew Product Introduction
Tech Stack
Tools & technologiesCyber SecurityPMP
About the role
Key responsibilities & impact- Drive cross-functional programs bringing new clinical products to market and enhancing existing products, focusing on Design Control and New Product Introduction
- Partner with R&D, business, operations, and engineering teams to define goals, milestones, and plans
- Lead product development from early concept through commercialization and post-launch
- Develop and maintain project plans, protocols, reports, and other program documentation
- Track progress and communicate results through data-driven reports and updates to senior leadership
- Manage Design Control gate reviews, design freezes, technical assessments, change control, and regulatory deliverables
- Facilitate team meetings, drive decisions, and surface and mitigate risks
- Guide trade-off and risk decisions across technical, business, and regulatory considerations
- Foster collaboration and problem-solving to resolve challenges and conflicts
- Coordinate joint development efforts with external partners
- Manage up to 4 programs simultaneously
Requirements
What you’ll need- Bachelor’s degree in Biology, Molecular Biology, Biochemistry, Bioinformatics, Computer Science, or a related technical discipline (or equivalent experience) required
- Project management certification or training (e.g., PMP or equivalent) required
- Minimum 4 years of program management experience in biotech, life sciences, or another regulated technical industry
- Background in research, assay development, systems engineering, lab operations, or software development highly desirable
- Familiarity with laboratory informatics systems and LIMS, sample accessioning, sequencing pipelines, and results reporting preferred
- Minimum 5 years of project budget management experience preferred
- Experience with software development lifecycle principles, data architecture patterns such as SOA, and agile tools such as Jira and GitLab a plus
- Experience creating and maintaining complex Gantt charts, project plans, and risk/RAID logs
- Expert proficiency with project management and scheduling tools such as SmartSheet or equivalent
- Understanding of product development under FDA Design Controls and relevant regulations desirable, including 21 CFR, ISO 13485, ISO 15189, EU IVDR, and Section 524B for Cybersecurity
- Exceptional communication and interpersonal skills
- Strong organization, resilience, adaptability, time management, and multitasking abilities
- Ability to work independently and contribute effectively to cross-functional teams
Benefits
Comp & perks- Comprehensive medical, dental, vision, life and disability plans for eligible employees and dependents
- Free testing for employees and immediate families
- Fertility care benefits
- Pregnancy and baby bonding leave
- 401(k) benefits
- Commuter benefits
- Employee referral program
