Job Description

Do you have a passion for innovative ideas and ground-breaking discoveries? With over $1.4 billion invested annually in R&D, at Thermo Fisher Scientific you’ll help solve some of the world’s toughest challenges, from giving cancer patients hope, ensuring safe drinking water and helping law enforcement tackle cases through forensics. We empower our teams to put science into meaningful action and give our R&D colleagues the autonomy, resources and tools they need to take science a step beyond.

Location/Division Specific Information
Work Location: Carlsbad, CA (on-site) OR Remote: Texas, Chicago, Arizona, North Carolina

Group: Life Sciences Solutions Group

Division: Clinical Next-Generation Sequencing Division

How will you make an impact?

As Staff Program Manager you will 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. You will complete program goals from initial concept and deal agreement through successful commercialization in coordination with external clients.

What will you do?

• 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.

How will you get here?

Education

• BS in Molecular Biology, Genetics, Engineering or related fields
• Certified Project Management Professional (PMP) preferred

Experience

• 7 years program management experience including principles, tools and applications. (i.e., timeline management, prioritization, cost estimation, risks 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.

Knowledge, Skills and Abilities

• 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.
• Potential to travel 0-25%.

This position has not been approved for relocation assistance.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Compensation and Benefits

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