Staff Program Manager, NGS - CDx at Thermo Fisher Scientific

Carlsbad, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Life Sciences, Healthcare, DiagnosticsIndustries

Requirements

BS in Molecular Biology, Genetics, or Engineering
Certified Project Management Professional (PMP) preferred
7+ years program management experience including principles, tools, and applications (e.g., timeline management, prioritization, cost estimation, risk analysis, and core team leadership)
Led multiple product development programs with an external partner to completion
Experience with regulated medical devices developed under 21 CFR Part 820 Subpart C - Design Controls (or other regulated product development such as drugs or biologics)
Proficiency with Project Management software to lead intricate program timelines and resources
Outstanding written and verbal presentation skills: Assertively and effectively articulates sophisticated concepts and ideas to broad audiences
Confidence interacting with all levels of management, stays focused and on-point, and able to raise problems or challenges in productive manner
Financial competence: Leads all aspects of program budgets, revenue modeling, and comfortable reporting into Profit & Loss (P&L) statements monthly
Outstanding influencing skills: Gets things done and drives decisions without formal authority
Strong interpersonal skills: Nurtures relationships across the matrixed organization to resolve discord thoughtfully

Responsibilities

Own the development, external relationship, financial model, and regulatory submission of Next Generation Sequencing (NGS) based Oncology Companion Diagnostic (CDx) assays within the Clinical Sequencing Division
Complete program goals from initial concept and deal agreement through successful commercialization in coordination with external clients
Serve as Core Team Lead and external point of contact for multiple CDx programs
Proactively identify risks and mitigations: Develop plans to address, facilitate tradeoff decisions at the portfolio level, raise to key internal partners, remove obstacles, and seek resolution
Develop and control program timelines in conjunction with both internal functions and external clients
Build and control budgets with Finance and external partners
Conduct internal and external team meetings: Ensure decisions are made with data, supervise progress, identify & implement risk mitigations, and action items are completed to support successful program execution
Present and communicate to senior leadership routinely during Product Approval Committee (PAC) meetings and additional PMO operating mechanisms
Ensure compliance to company Product Commercialization Process (PCP) and Quality Management Systems (QMS) for developing regulated products

Skills

Key technologies and capabilities for this role

Program ManagementNGSCompanion DiagnosticsOncologyRegulatory SubmissionRisk ManagementBudget ManagementTimeline ManagementFinancial ModelingCross-functional LeadershipStakeholder Management

Questions & Answers

Common questions about this position

Is this position remote or does it require on-site work?

The position is remote or, if local, on-site in Carlsbad, CA or Austin, TX.

What education and certifications are required for this role?

A BS in Molecular Biology, Genetics, or Engineering is required, and Certified Project Management Professional (PMP) is preferred.

What experience is needed for the Staff Program Manager position?

Candidates need 7+ years of program management experience, including leading multiple product development programs with external partners to completion and experience with regulated medical devices under 21 CFR Part 820 Subpart C - Design Controls.

What key skills are essential for success in this role?

Proficiency with Project Management software, outstanding written and verbal presentation skills, and confidence interacting with all levels of management are essential.

What is the salary or compensation for this position?

This information is not specified in the job description.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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