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 sophisticated analytical challenges, improving patient diagnostics and therapies, or increasing efficiency in their laboratories, we are here to support them.
Location/Division Specific Information
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 vital 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 innovative 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.
* Participate in the verification of test methods for strength, impurities, identity, and dissolution by HPLC, qPCR, ELISA, 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 crafting documentation of the testing/analysis and results. Record and report result of analysis in accordance with prescribed lab procedures and systems.
* Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
* Collaborate with clients, internal partners, and outsource labs
How will you get here?
Bachelor's degree in Molecular Biology, Chemistry, Biology or Pharmaceutical Science. Advanced degree preferred.
Bachelor's degree with5 years of scientific experience, including 3 years in a related life sciences field OR
Master's degree, with 4 years of related experience OR
PhD, typically with 1-3 years experience.
Experience working directly with clients in a CDMO environment is helpful.
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 CGE.
* Proficiency with Molecular Biology assays including qPCR, ELISA, Fragment Analyzer, Bioanalyzer AGE and PAGE electrophoresis.
* Proficiency with Microbiology assays is a plus.
* 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.