Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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. Our global team of more than 75,000 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.
How will you make an impact?
You will initiate and lead quality investigations in the Analytical Development (AD) department, including OOS and unexpected results investigations and Deviations.
What will you do?
Initiates and leads investigations and authors investigation reports in TrackWise.
Provides technical leadership on analytical investigations.
Conducts investigations with input from stability and/or development Supervisor.
Directs Research Chemists in performance of lab investigations.
Interacts with other departments(e.g., PPT, PM, QA), clients and with Subject Matter Experts (SMEs) as required to thoroughly investigate incidents and appropriate Corrective and Preventative Actions (CAPA).
Ensures that investigations are ready for approval and completed within required timelines. Provides excellence in data integrity and GMP/procedural compliance.
Designs and facilitates effective CAPA’s. Owns CAPA as needed.
Challenges the department on quality issues and system improvements
Other related duties as assigned.
How will you get there?
B. Sc. in Chemistry
Minimum 5 years analytical chemistry experience within the pharmaceutical industry
Previous experience leading people or a team
Previous experience in providing client service in the contract pharmaceutical industry
Previous method validation and product stability testing/reporting experience in the pharmaceutical industry
Previous investigation experience in a Good Manufacturing Practices (GMP) analytical laboratory environment
Equivalent combination of education, training and relevant work experience may be considered.
Exceptional knowledge of Good Manufacturing Practices, and United States Food and Drug Administration (FDA) compliance.
Strong interpersonal and communications skills (both oral and written).
Excellent organizational skills with proven ability to prioritize when timeline conflicts exist. Ability to problem solve and troubleshoot.
Ability to carry out investigations in a collaborative manner with AD staff and to effectively interact with internal and external suppliers and clients.
Proficient in Microsoft skills (Word, Excel, Power Point).
Proficiency with the English language.
Some weekend work may be required.
There is little physical effort and fatigue. Walk , stands and lifts small objects and tools and/or operates keyboard equipment for short duration (e/.g. lifts very light items such as a stapler). Typically located in a comfortable indoor area. There may be regular exposure to mid physical discomfort from factors such as dust, fumes or odors, temperature extremes, loud noise, strong drafts or bright lights.
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.