Program Manager III, Companion Diagnostics

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division-Specific Information:

Carlsbad, CA. Relocation assistance is NOT provided.

Must be legally authorized to work in the United States without sponsorship.

Must be able to pass a comprehensive background check, which includes a drug screen.

Discover Impactful Work:

Manage defined project workstreams that contribute to NGS-based oncology companion diagnostic programs. You will coordinate work across scientific, clinical, regulatory, quality, and operational teams; maintain plans for your assigned scope; and resolve day-to-day execution issues. You will work within established program objectives and governance, bringing decisions that affect overall program direction, partner commitments, or functional priorities to the program or functional leader.

A Day in the Life:

• Manage the workplan for assigned workstreams, including activities, deliverables, dependencies, milestones, and acceptance criteria, within agreed objectives and scope.
• Coordinate contributors across assay and reagent development, bioinformatics and software, clinical and analytical validation, regulatory affairs, quality, manufacturing, supply chain, commercial, and customer support.
• Translate approved requirements into clear workstream tasks and track progress against the agreed plan.
• Maintain schedules, action items, risks, dependencies, and decision records for assigned work; identify potential impacts to timing, resources, or quality.
• Prepare concise status updates and materials for team reviews, highlighting progress, open issues, and decisions needed.
• Coordinate routine information exchange with external partners for assigned activities, following established communication plans and escalating changes to commitments or expectations.
• Track workstream activities related to design controls, risk management, traceability, verification and validation, change control, and regulatory submissions, in partnership with Regulatory Affairs and Quality.
• Coordinate assigned clinical or analytical validation activities against approved study plans and program milestones.
• Track budget, forecast, and resource information for assigned work and report variances to the program or functional leader.
• Coordinate assigned launch-readiness or lifecycle activities, such as readiness tracking, documentation, and follow-up on team actions.
• Identify and resolve day-to-day execution issues with relevant team members; recommend options and escalate issues that affect approved scope, program milestones, quality, or partner commitments.
• Apply program-management practices and relevant business or technical knowledge to improve the execution of assigned work.
• Adapt workstream plans to approved changes in data, requirements, or priorities and communicate impacts to affected contributors.

Keys to Success:

Education

• Bachelor’s degree in molecular biology, genetics, biochemistry, biomedical engineering, engineering, or a related scientific or technical discipline required.
• An advanced degree is a plus.
• PMP or equivalent program-management certification is preferred.

Experience

• 5+ years of related experience with a bachelor’s degree, or 3+ years with an advanced degree or equivalent work experience.

• Experience managing project workstreams or coordinating cross-functional activities in a regulated product-development environment, such as diagnostics, IVD, medical devices, clinical testing, biotechnology, or pharmaceuticals.

• Experience maintaining plans and delivering defined project activities through one or more stages of development, validation, regulatory submission, launch, or lifecycle management.

• Familiarity with oncology, precision medicine, NGS, molecular diagnostics, companion diagnostics, or a related clinical testing platform is preferred.

• Experience coordinating work with external partners, vendors, clinical teams, or CROs is preferred.

• Working knowledge of regulated product-development practices, including design controls, risk management, traceability, verification and validation, and quality systems.

• Experience using program-management tools to track schedules, dependencies, risks, and resources.

• Knowledge, Skills, and Abilities

• Strong organization, follow-through, and attention to detail.

• Clear written, verbal, and presentation skills.

• Sound judgment in prioritizing work and resolving day-to-day issues.

• Ability to coordinate effectively across scientific, clinical, regulatory, quality, and operational teams.

• Ability to recognize risks and dependencies, recommend practical actions, and escalate decisions when needed.

• Ability to apply established methods and procedures while adapting plans to changing project information.

Benefits

• We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

• Compensation and Benefits

• The salary pay range estimated for this position Program Manager III based in California is $90,900.00–$120,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

• For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards