Thermo Fisher Scientific

Staff Program Manager (Transplant Diagnostics)

Indiana, United States

Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Diagnostics, Medical Devices, Biotechnology, Life SciencesIndustries

Requirements

Candidates should possess a Bachelor's degree in Life Sciences, with an advanced degree (MS, MBA, or equivalent) being preferred. A minimum of 4 years of project management experience in the life sciences or medical device industry is required, with clinical experience and experience developing RUO and IVD assays, including clinical study performance, being preferred. PMP certification is a plus, and Six Sigma certification is highly desirable. Demonstrated excellence in project management, including timeline adherence, deliverable tracking, and proactive risk management, is essential. Strong interpersonal, influencing, written and verbal communication, presentation, and conflict-resolution abilities are also required, along with strong attention to detail, commitment to quality, and the ability to be self-motivated, curious, resourceful, and contribute positively to team culture.

Responsibilities

The Staff Program Manager will lead core project teams, conduct regular project meetings, capture action items, supervise deliverables, and provide updates to senior leadership. They will guide the development, validation, and implementation of assays, aligning them with market needs, regulatory guidelines, and customer requirements. The role involves working closely with R&D, Manufacturing Sciences, Quality, Regulatory, Clinical Affairs, and Commercial teams to define project deliverables. Responsibilities include identifying potential risks and issues, developing effective mitigation strategies, and maintaining clear communication across all teams to ensure timely project completion. The manager will proactively manage complex issues in a dynamic, cross-functional environment to support business priorities.

Skills

Project Management
RUO assays
IVD assays
Regulatory
Quality
Cross-functional leadership
R&D
Manufacturing Sciences
Clinical Affairs
Commercial alignment
Risk management
Assays development and validation
Cross-team communication

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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