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Scientist III, Technical Operations

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

How will you make an impact?

One Lambda, a division of Thermo Fisher Scientific, seeks a Scientist Level 3 for our Technical Operations team. This key role is central to addressing manufacturing enhancements, leading investigations, and ensuring product quality and compliance with regulatory standards. The successful candidate will collaborate across departments to streamline processes, validate methods and equipment, and drive project completion. With a focus on innovation and operational excellence, this position requires a blend of technical expertise, project management skills, and a commitment to maintaining the highest standards of quality in healthcare solutions.

Key Responsibilities:

• Conduct thorough evaluations of alternate materials, compare specifications, and ensure quality and reliability.
• Coordinate, perform and write validation reports for process, shipping stability, equipment and test methods, which include valid statistical rationale.
• Collaborate seamlessly with cross-functional teams such as procurement, quality assurance, research and development, manufacturing, regulatory, and product management.
• Maintain accurate documentation, follow standard operating procedures (SOPs), and ensure compliance with regulatory requirements.
• Effectively manage various project tasks including project timelines, coordinating activities, monitoring progress, and ensuring timely completion of tasks.
• Lead root cause investigation and propose solutions for manufacturing challenges or recurring issues.
• Maintain knowledge and comprehensive understanding of relevant medical device regulations and current interpretations affecting equipment, product and process validation.
• Train and provide support to Operations to ensure protocols are performed as intended.

How will you get here? (minimum requirements)

• Bachelor’s degree in Biological Sciences, Chemistry, Molecular Biology or Engineering
• 3+ years manufacturing in an IVD industry, cGMP and/or ISO regulations for diagnostics manufacturing required or 2+ years demonstrated experience in material evaluation.
• Hands-on experience with qPCR, NGS and cell culture is preferred.
• Direct working experience with manufacturing processes is preferred.
• Ability to work 100% onsite.

Knowledge, Skills, Abilities

• Self-starter, independent, and a proactive driving force of execution.
• Knowledge and experience with shipping stability and process validation preferred.
• Knowledge and experience of material assessment.
• Strong project management and organizational skills.
• Ability to exercise independent judgment in decision making and execution.
• Familiarity with Quality System Regulations and ISO 13485 regulations.
• Good analytical skills, with an ability to use scientific knowledge and statistical methods to identify root causes of process and product failures.
• Excellent verbal and written communication skills.
• Able to work independently and in a team environment.
• Performs all job duties in a safe manner, consistent with the Code of Ethics.

Our global team of more than 130,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.

For more information, please visit www.thermofisher.com

Benefits:

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension/retirement, 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.

EEO/Reasonable Accommodation:

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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