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.
How will you make an impact?
The Bend, Oregon Thermo Fisher Scientific site consists of approximately 100 highly motivated employees focused on contract early phase clinical drug product formulation development and manufacture. The site is a part of Pharma Services, which also encompasses manufacture of drug substance, scale up, clinical distribution, and commercial drug product launch. Bend, Oregon is a beautiful community of around 95,000 people commonly known as ‘the outdoor playground of the West’ because of the myriad of available outdoor activities and desirable living conditions.
What will you do?
Evaluate, develop, and validate analytical methods for release of clinical development material. You’ll contribute to the development of new scientific methods. Provide analytical support for pre-clinical and clinical development material.- Manages multiple project timelines, ensure deliverables are met, delegates tasks to supporting scientists, mentors other scientists, and leads technical discussions with clients.
- Leverages extensive experience with various analytical techniques, such as HPLC, Dissolution, GC and KF.
- Applies extensive knowledge of method development techniques, method validation parameters, and regulatory guidelines such as USP and ICH.
- Writes, executes, and approves validation protocols, reports, and methods in accordance with regulatory guidelines.
- Records and reports results of analysis in accordance with prescribed lab procedures and systems.
- Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and obtained results.
- Reviews and analyzes analytical test results, makes recommendations for analytical methods and experimental design. Leads technical discussions with internal team and external clients.
- Manages multiple project timelines, ensures deliverables are met, delegates tasks to supporting scientists as needed.
- Researches current methodologies and implements new methodologies and processes with supervisor support and approval.
- Contributes to maintaining a clean and organized laboratory workspace consistent with management expectations.
- Collaborates with internal scientific, analytical, and laboratory functional areas to meet project and team objectives.
- Mentors other scientist throughout the company.
- Leads process improvements.
- Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the necessary compliance status required by company and facility standards.
How will you get here?
Education- Ph.D in Chemistry, Biochemistry, Biology, or related physical science preferred, equivalent work related experience will be considered.
Experience- At least 15 years working in a laboratory environment.
- At least 10 years of HPLC experience performing assay/related substance analysis and other chromatographic or spectroscopic techniques.
- At least 5 years of method development and validation experience.
- Extensive experience with Dissolution and other analytical techniques.
- Experience with client communications.
- Experience with small molecules, amorphous dispersions and oral solid doses preferred.
Knowledge, Skills, Abilities- Excellent knowledge and understanding of basic instrumental technologies.
- Excellent knowledge of qualitative and quantitative chemical analysis.
- Knowledge of Good Manufacturing Practices and data integrity (ALCOA).
- Excellent critical and logical thinking skills.
- Effective written, interpersonal, and presentation skills.
- Ability to read, analyze, and interpret technical procedures.
- Ability to apply mathematical operations to such tasks as determination of test reliability, analysis of variance, and correlation techniques.
- Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
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