Scientist II
$150,000–$200,000 year
On-siteSt. Louis, Missouri, United States
Job Summary
Execute analytical method transfer, verification, validation, and troubleshooting for biologic and small molecule pharmaceutical products. Perform routine and non-routine testing of raw materials, in-process samples, finished products, and stability studies while supporting technical investigations and regulatory submissions. Maintain analytical instrumentation and laboratory systems, authoring methods, protocols, and SOPs in compliance with cGMP and GDP. Collaborate with Quality, Manufacturing, and Validation teams to ensure efficient execution of activities, providing training and technical guidance to laboratory personnel. Support occasional off-shift or weekend work as business needs require.
Required Qualifications
- Bachelor's degree in Chemistry, Biochemistry, or a related scientific field
- 5+ years of relevant industry experience
- Master's degree
- 3+ years of relevant industry experience
- Ph.D.
- 2+ years of relevant industry experience
- Experience supporting Quality Control or Analytical Development activities within GMP-regulated pharmaceutical, biotechnology, or CDMO environments
- Experience with biologics (proteins, peptides, monoclonal antibodies) and small molecule pharmaceutical products
- Hands-on experience performing analytical method transfer
- Hands-on experience performing method validation
- Hands-on experience performing compendial verification
- Hands-on experience performing troubleshooting
- Hands-on experience performing analytical testing
- Experience with HPLC
- Experience with UPLC
- Experience with LC-MS
- Experience with GC-MS
- Experience with FTIR
- Experience with SDS-PAGE
- Experience with ELISA
- Experience with Western Blot
- Experience with protein concentration assays
- Experience with Karl Fischer titration
- Experience with pH analysis
- Experience with general wet chemistry methods
- Proficiency with chromatography data systems
- Proficiency with laboratory software platforms
- Experience with Empower
- Experience with Chromeleon
- Strong understanding of cGMP regulations
- Knowledge of FDA guidance
- Knowledge of ICH guidance
- Understanding of method validation principles
- Understanding of data integrity requirements
- Understanding of laboratory safety standards
- Demonstrated ability to troubleshoot analytical issues
- Ability to critically evaluate data
- Ability to perform statistical calculations
- Ability to generate technical reports
- Ability to generate protocols
- Ability to generate SOPs
- Ability to generate other scientific documentation
- Ability to provide scientifically sound recommendations
- Ability to provide scientifically sound conclusions
- Strong verbal and written communication skills
- Ability to collaborate effectively across cross-functional teams
- Ability to manage multiple priorities
- Ability to meet deadlines
- Ability to work in a fast-paced pharmaceutical manufacturing environment
- Support occasional off-shift activities
- Support weekend activities
- Support manufacturing-related activities
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