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Thermo Fisher Scientific

Lab supplies, instruments, and biopharma services

Senior Manager - Quality

Full-Time
No salary listed
Senior
Bachelor's, Master's
Oakwood, OH, USA
In Person

About the job

Requirements
  • An advanced degree plus 6 years of experience, or a bachelor's degree plus 8 years of experience, in the pharmaceutical, medical device, or regulated life sciences industry.
  • Five or more years of quality management or leadership experience.
  • Expert knowledge of global quality standards, including ISO 9001:2015 and ISO 17025.
  • Strong understanding of quality management systems and Good Manufacturing Practice requirements.
  • Demonstrated experience leading quality investigations, CAPA, and change control processes.
  • Experience implementing continuous improvement initiatives.
  • Experience with quality tools including FMEA, risk analysis, and root cause analysis.
  • Experience hosting regulatory inspections and customer audits.
  • Proficiency with quality management software systems.
  • Ability to travel up to 10%.
Responsibilities
  • Guide strategic quality initiatives and support a culture of continuous improvement across the organization.
  • Oversee quality management systems, ensure regulatory compliance, and enhance customer experience through quality standards.
  • Develop and implement quality strategies in collaboration with cross-functional teams.
  • Manage quality assurance and quality control teams while partnering with operations, research and development, commercial teams, and customers.
  • Guide process improvements through Practical Process Improvement methodologies and risk-based approaches.
  • Maintain inspection readiness, manage customer relationships, and ensure compliance with global regulatory requirements.
  • Support quality initiatives as a member of the site leadership team while meeting business objectives.
  • Develop quality professionals, lead investigations, and implement data-driven solutions that enhance quality systems and customer satisfaction.
Desired Qualifications
  • Preferred fields of study include Science, Engineering, Chemistry, or a related technical field.
  • Professional certifications such as ASQ or Lean Six Sigma are desired.
  • Excellent project management and cross-functional leadership abilities.
  • Strong data analysis and problem-solving capabilities.
  • Excellent written and verbal communication skills.
  • Ability to build collaborative relationships at all levels.

About the company

T

Thermo Fisher Scientific

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Thermo Fisher Scientific supplies labs, hospitals, and biotech firms with a broad range of products and services, from basic lab consumables to advanced analytical instruments and outsourced drug development. Its offerings work by combining high-tech instruments for genomics, diagnostics, and research with consumables and a global distribution network to deliver end-to-end workflows that turn samples into data and insights. The company differentiates itself through its massive, diversified portfolio and its integrated end-to-end reach—from tools and reagents to support services—built on the legacy of Fisher Scientific’s distribution strength and Thermo Electron’s instrument innovation, backed by a history of strategic acquisitions. The goal is to be the dominant partner in science and healthcare by enabling researchers and clinicians to perform work more efficiently and at larger scale, spanning discovery, development, and manufacturing.

Company Size

10,001+

Company Stage

IPO

Headquarters

Waltham, Massachusetts

Founded

1956

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Simplify's Take

What believers are saying

  • Q2 2026 revenue rose 10% to $11.99 billion, with 13% adjusted EPS growth.
  • May 2026 Precure with Mayo Clinic targets a million-biospecimen dataset and proteomics leadership.
  • June 2026 NVIDIA, September 2026 Evosep, and CHO-K1 launches widen Thermo Fisher’s platform pull.

What critics are saying

  • Organic revenue grew only 1% in Q1 2026, exposing acquisition dependence.
  • The August 2026 microbiology sale removed $645 million revenue and cut Specialty Diagnostics depth.
  • Clario’s $8.875 billion deal needs $175 million synergies; failure damages 2027 earnings credibility.

What makes Thermo Fisher Scientific unique

  • Thermo Fisher spans consumables, instruments, services, and trial data across every lab workflow.
  • March 2026 Clario added endpoint-data infrastructure, linking instruments to clinical-trial evidence generation.
  • Thermo Fisher’s 2026 launches, from CHO-K1 media to Multiskan Ease, cover routine lab demand.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

Hybrid Work Options

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Fertility Treatment Support

Family Planning Benefits

Professional Development Budget

Conference Attendance Budget

Wellness Program

Mental Health Support

Gym Membership

Phone/Internet Stipend

Home Office Stipend

Company News

Business Wire
Oct 6th, 2026
Thermo Fisher unveils OSD Express and expands drug development capabilities at CPHI Milan 2026

Thermo Fisher Scientific is showcasing expanded drug development and manufacturing capabilities at CPHI Milan 2026, running 6-8 October. The company is introducing OSD Express for oral solid dose development and expanding small molecule capabilities through collaboration with AustinPx, which provides access to KinetiSol Technology for improving drug bioavailability. The firm is investing in tableting, laboratory and packaging facilities across France, Canada and North America. For sterile products, new Steriles Express Solutions aim to deliver Phase I or II clinical trial material in 20 weeks. Thermo Fisher is also expanding bioprocessing capacity and clinical trial supply infrastructure, including a 52,000-square-foot facility in New York. The company is deploying generative AI to reduce master informed consent form drafting time by 50%. Thermo Fisher generates over $45 billion in annual revenue.

BioPharma Watch
Oct 6th, 2026
Thermo Fisher Scientific showcases new solutions and expanded capabilities to accelerate Drug Development at CPHI Milan 2026.

Thermo Fisher Scientific showcases new solutions and expanded capabilities to accelerate Drug Development at CPHI Milan 2026. Key Takeaway: Thermo Fisher Scientific is set to showcase its expanded drug development and manufacturing capabilities at CPHI Milan 2026. The company aims to assist pharmaceutical and biotechnology firms in navigating complex commercialization processes. Among its new offerings is OSD Express, designed to enhance predictability in drug development. Market sentiment analysis. Positive factors. * Thermo Fisher Scientific is expanding its drug development capabilities. * New solutions aim to help companies navigate commercialization paths. * Showcasing innovations at a major industry event enhances visibility. New development solutions, expanded global capacity, and advanced digital technologies help pharma and biotech companies reduce complexity and scale toward commercialization Key facts. - New solutions for drug product development:New OSD Express and Steriles Express Solutions provide defined development approaches designed to increase predictability and help programs advance more efficiently, while Accelerator(TM) Drug Development connects capabilities across development to reduce handoffs and maintain continuity. - Expanded capabilities and capacity:Investments across oral solid dose, sterile drug product, biologics, and clinical supply are expanding development and manufacturing capabilities globally, including new small molecule technologies through Thermo Fisher's collaboration with AustinPx. - Technology delivering measurable impact:AI, data, and digital technologies are being applied across clinical development, including generative AI applications that reduced master informed consent form draft time by 50% and, in some studies, reduced CRA site enrollment and activation activities by 15-30%. MILAN-(BUSINESS WIRE)-Thermo Fisher Scientific, the world leader in serving science, is expanding its drug development, manufacturing, and clinical capabilities to help pharmaceutical and biotechnology companies navigate increasingly complex paths to commercialization, reduce friction, and maintain momentum. The company will showcase these new and expanded capabilities at CPHI Milan 2026, Oct. 6-8. Among the new offerings isOSD Express, a defined solution designed to increase predictability and advance oral solid dose development more efficiently. The offering reflects the broader approach ofAccelerator(TM) Drug Development, which connects scientific expertise and capabilities across drug development, clinical trials, endpoint solutions, clinical supply, and laboratory services to reduce handoffs and help customers maintain continuity as programs advance. Additionally, Thermo Fisher is expanding small molecule capabilities through its collaboration withAustinPx, giving customers access to KinetiSol(TM) Technology, a solvent-free technology designed to improve the bioavailability of poorly soluble drugs and support development and scale-up through commercial manufacturing. Targeted investments in tableting, laboratory, and packaging capabilities are also expanding oral solid dose development and commercial manufacturing, including new Gerteis technology for advanced dry granulation and improved tablet manufacturing efficiency in Bourgoin, France, and Whitby, Canada, and serialized packaging capabilities in Cincinnati and Toronto. For sterile drug product programs,Steriles Express Solutionsprovide a defined approach for early development and late-stage technology transfer. Steriles Express Early Development is designed to provide Phase I or II clinical trial material in as little as 20 weeks, while Steriles Express Tech Transfer can provide a Phase III GMP batch in as little as 26 weeks.* Supporting these pathways are continued investments in sterile drug product capacity, including new and expanded lines in Plainville, Massachusetts; Monza, Italy; and Ferentino, Italy, for development and commercial manufacturing of vials and prefilled syringes. Thermo Fisher is also expanding fill-finish and drug-device capabilities in Ridgefield, New Jersey, including through its previously announcedcollaboration with SHL Medical. "Drug development increasingly depends on decisions and capabilities that span traditional boundaries, from development and manufacturing to clinical supply and clinical execution," said Mike Shafer, Executive Vice President and President, Biopharma Services, Thermo Fisher Scientific. "We're investing not only in capacity, but in how those capabilities connect. That gives our customers greater continuity as they navigate critical transitions, scale their programs, and prepare for commercialization." Strengthening capabilities across the development pathway. Beyond drug product, Thermo Fisher continues to invest in capabilities across biologics development, manufacturing, and clinical supply. New bioprocessing equipment in Plainville will expand U.S.-based cGMP monoclonal antibody manufacturing capacity, while the recently openedU.S. Bioprocess Design Centerhelps customers translate process innovations into scalable solutions for biologics development and manufacturing. Thermo Fisher has also expanded its Gibco(TM) cell culture media portfolio withCHO-K1 Catalog Panel Media and Feed, a cGMP-ready portfolio designed to support cell growth and protein production. In clinical trial supply, a 52,000-square-foot expansion in Bohemia, New York, will increase clinical label manufacturing capacity, while a new facility in Heiwajima, Tokyo, is expected to approximately double Japan's storage, distribution and secondary packaging capacity, ranging from controlled ambient to ultra-low temperature. Across the global clinical supply network, Thermo Fisher is also making significant investments in technologies supporting drug-device combination product assembly, labeling and packaging. These scalable technologies enable fit-for-phase automation, supporting programs from early clinical development through commercialization as volume and complexity increase. Applying digital technologies and data to improve development execution. Thermo Fisher is applying AI, data, and digital technologies to improve execution and support more informed decisions across clinical development. Within the PPD(TM) clinical research business, generative AI is being used to accelerate clinical development activities, including a50% aggregate reductionin master informed consent form draft time. Thermo Fisher is also expanding evidence-generation capabilities through thePPD(TM) CorEvitas(TM) Vitiligo Registry, designed to generate longitudinal real-world evidence on treatment effectiveness, disease burden, and patient outcomes. In digital clinical solutions,Clario's eCOA Swiftcaptures patient-reported data in early-stage oncology trials to help sponsors better understand tolerability and patient impact as programs advance. Thermo Fisher experts share insights at CPHI Milan. These shifts in how drug development is executed, from the role of strategic partnerships to the practical application of AI, will also be explored by Thermo Fisher experts at CPHI Milan: CDMO Consolidation: Strategic Partnerships or Dangerous Dependencies?- Hannah Spaepen, Senior Director, CMC Portfolio Management, Pharma Services, will participate as a panelist Tuesday, Oct. 6, from 11:35 a.m. - 12:20 p.m. CET. Putting AI to work in drug development: Practical applications that deliver measurable value- Anil Kane, Global Head of Technical and Scientific Affairs, Pharma Services, will present Wednesday, Oct. 7, from 1:45 - 2:10 p.m. CET. To learn more about these and other developments, visit Thermo Fisher Scientific atbooth 6A2, where specialists in drug development, manufacturing, and clinical services will be available throughout the conference to discuss customer needs and challenges. * Actual Steriles Express timelines may vary based on defined program parameters and scope. About Thermo Fisher Scientific. Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $45 billion. Its Mission is to enable its customers to make the world healthier, cleaner and safer. Whether its customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics, or the development and manufacture of life-changing therapies, BiopharmaWatch is here to support them. Its global team delivers an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. For more information, please visit www.thermofisher.com. Frequently asked questions. What is Thermo Fisher showcasing at CPHI Milan 2026? Thermo Fisher is showcasing its expanded drug development and manufacturing capabilities. What is OSD Express? OSD Express is a new solution designed to increase predictability in drug development. When is CPHI Milan 2026 taking place? CPHI Milan 2026 will be held from October 6 to 8. Who does Thermo Fisher aim to assist? Thermo Fisher aims to assist pharmaceutical and biotechnology companies.

Yahoo Finance
Sep 28th, 2026
Thermo Fisher Scientific to resell Evosep Eno separation platform for proteomics workflows

Evosep has entered a reseller agreement with Thermo Fisher Scientific for its Evosep Eno separation platform. Through the partnership, Thermo Fisher Scientific will offer the platform as part of its mass spectrometry solutions portfolio, combining its global reach with Evosep's separation technology. The Evosep Eno platform addresses the need for standardised proteomics in research, drug discovery, and clinical applications. It delivers robustness, ease of use, and throughput whilst minimising operational complexity. Customers will be able to purchase Evosep Eno directly through Thermo Fisher Scientific. The platform enables standardised separations across laboratories, instruments, and operators, supporting reproducible results for large-scale studies. The agreement supports applications including population studies, biomarker discovery, drug development, and clinical proteomics initiatives.

Epium Ltd
Sep 25th, 2026
AI accelerator cards reshape DNA sequencing workflows.

AI accelerator cards reshape DNA sequencing workflows. The global market for AI DNA sequencer base-calling accelerator cards is expanding as genomics workflows require faster, more accurate nucleotide identification. These specialized compute modules offload signal processing and deep-learning inference from host CPUs, reducing data-transfer bottlenecks and enabling on-instrument analytics that once depended on large data-center environments. Growth is tied to rising sequencing demand, with sequencing expenditures projected to surpass US$ 30 billion annually. Long-read and single-cell applications are increasing the need for flexible AI-optimized compute, while clinical diagnostics, research and development, and personalized medicine are key application areas. On-premise integration, cloud-connected systems, and hybrid edge deployments are shaping adoption models. NVIDIA, Intel, Illumina, and Thermo Fisher Scientific lead the competitive field through GPU, ASIC, FPGA, and platform-specific approaches. Illumina has introduced the NovaBase AI card, while Thermo Fisher Scientific offers the Ion Torrent Accelerate Card. AMD, Xilinx, Hewlett Packard Enterprise, Cisco, Qualcomm, IBM, Pacific Biosciences, Oxford Nanopore Technologies, Roche Sequencing Solutions, BGI Genomics, and QIAGEN are pursuing specialized roles across the ecosystem. Europe is positioned as a highly advanced market due to strong research networks, privacy regulation, and sustainability priorities. North America benefits from federal research funding and biotech activity, while Asia-Pacific shows strong potential through expanding genomics infrastructure in China, Japan, South Korea, and India.

MarketScreener
Sep 23rd, 2026
Thermo Fisher Scientific inc. launches Gibco? CHO-K1 Catalog Panel media and feed.

Thermo Fisher Scientific inc. launches Gibco? CHO-K1 Catalog Panel media and feed. Published on 09/23/2026 at 11:43 am EDT S&P Capital IQ Thermo Fisher Scientific announced the Gibco? CHO-K1 Catalog Panel, a cGMP-ready portfolio of basal and feed media designed to support strong cell growth and protein production across CHO-K1 cell lines. Available in liquid and dry powder media (DPM) formats, the panel can offer flexible options for process development, scale-up, and manufacturing. The panel consists of multiple basal media and feed combinations designed for a broad range of CHO-K1 cell lines, helping development teams rapidly identify medium and feed combinations that support higher performance. The chemically defined (CD), animal origin-free (AOF) formulations are cGMP-ready to support regulatory considerations. The Gibco CHO-K1 Catalog Panel helps upstream process development teams identify high-performing media and feed combinations. In a 14-day fed-batch study using a CHO-K1 GS cell line, select panel combinations demonstrated: · Up to 73% higher titer compared with the benchmark catalog media and feeds tested · Up to 202% higher peak viable cell density compared with the benchmark products tested · Strong product quality performance across tested conditions A cGMP-ready portfolio of basal and feed media for CHO-K1 cell culture and protein production. Biologics and biosimilars developers using CHO-K1 cell lines. It helps provide multiple ready-to-use media and feed options for evaluating and optimizing diverse CHO-K1 cell culture workflows. The panel combines demonstrated productivity and product quality performance with CD, AOF, cGMP-ready formulations and scalable liquid and DPM formats to support CHO-K1 process development through manufacturing. (C) S&P Capital IQ - Business Wire - 2026