Under minimal direction, conduct all activities associated with pharmaceutical dissolution studies including method development, method validation, release and stability testing. Current understanding of cGMP principles required.
• Perform method development and validation on dissolution methods
• Perform dissolution testing on release and stability samples
• Perform analysis by HPLC and UV/VIS
• Adhere to cGMP principles by following internal SOP's and methodologies
• Document results in a laboratory notebook according to Good Documentation Practices
• Perform technical peer review
• Work with QA and analysts to resolve investigations/deviations/out-of-trend
• Maintain appropriate level of training per required training curriculum
• BA/BS degree in a scientific discipline with 7 - 9 years related experience; OR Master's degree with 4 - 6 years related experience; OR Doctorate Degree with 0 - 2 years related experience, required.
• Ability to professionally interact with internal associates (analysts and analytical senior managers) and external clients.
• Clear verbal and written communication skills
• Demonstrated ability to work with Hazard Category 1-5 and DEA Schedule 1-5 compounds, required.
• Basic computer skills (word processing, spreadsheets)
• Experience with HPLC, required.
• GMP experience, required.
• Experience with method validation, required.
• Experience in the pharmaceutical or CRO industry, preferred.
• Dissolution experience, preferred.
Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com
More products. Better treatments. Reliably supplied.™
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.
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