Scientist III, Process Development - Analytical Dev. Scientist

Employment Type

: Full-Time


: Miscellaneous

Job Description Job Title: Analytical Development Scientist 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. Location/Division Specific Information Carlsbad-CA At Microbial Material Services (MMS), a new Business Unit within Thermo Fisher Scientific's Pharma Services Group, we deliver, from process development through commercial supply, the expertise and resources necessary to help clients deliver innovative plasmid-based therapeutics as critical raw materials, drug substances, and drug products. Placed in the forefront of our leading- and cutting-edge Cell and Gene Therapy businesses enabling clients to cure genetic, rare, and otherwise untreatable diseases as their CDMO of choice. How will you make an impact? As an Analytical Development Scientist, you will evaluate, develop and optimize analytical methods for complex testing of raw materials, plasmid drug substance and drug product, release and stability samples. You will participate in the validation of analytical test methods. You will introduce the use of new technology to the laboratory. What will you do? * Evaluate, develop and optimize complex analytical testing methods. * Mass spectrometry and liquid chromatography expertise * Participate in the validation of test methods for strength, impurities, identity, and dissolution by HPLC, GC, and spectroscopy. * Coordinate research and apply it to innovative drug development internally and for client products. * Presents recommendations internally and to clients. * Solves problems related to analytical testing. * Clearly and accurately communicate the results of work by creating documentation of the testing/analysis and obtained results. Record and report results of analysis in accordance with prescribed lab procedures and systems. * Maintain and organize work area, instrumentation, and testing materials. * Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Collaborate with clients, internal stakeholders, and outsource labs How will you get here? Education * Bachelor's degree in physical science, preferably in Chemistry or Biology. Advanced degree preferred. Experience * Typically Bachelor's degree requires 5 years of progressive scientific experience, including 3 years in a related life sciences field. * If related Master's degree, typically requires 4 years of related experience. * If related PhD, typically requires 3 experience. * Experience working directly with clients in a CDMO environment is preferred. Knowledge, Skills, Abilities * Excellent knowledge and understanding of chemistry and analytical instrumental technologies. * Excellent understanding of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry. * Excellent problem solving skills and logical approach to solving scientific problems. * Proficiency with HPLC, GC, LC/MS and Dissolution techniques (method development and validation). * Excellent interpersonal and communication skills (both oral and written). Good presentation skills to present information to customers, clients, and other employees. Good leadership skills. * Ability to read, analyze, and interpret technical procedures and governmental regulations. Ability to write standard operating procedures and policy manuals. 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 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.

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