Azzur Group
Location
Thousand Oaks, CA | United States
Job description
Location: Thousand Oaks, CA
Department:Azzur Consulting LLC
From Discovery to Delivery™, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs. From Azzur Cleanrooms on Demand™ facilities, to our labs, training centers and consulting offices across the nation, Azzur Group helps organizations start, scale, and sustain their growing enterprises. With nearly four decades of service to the life science community, we have become a trusted partner to the world's leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain.
Essential Duties and Responsibilities:
Plan, prioritize, execute, and implement analytical assays
Support Quality Control Analytical Method Transfers
Develop Transfer/Validation/Verification protocols for QC Analytical Methods
Develop and execute test method transfers/validation/verification protocols for one or more of the following:
Appearance
Peptide Mapping-HPLC
SDS-PAGE by Western Blot
Reverse Phase-HPLC
Size Exclusion-HPLC
Cellular Uptake (Bioassay)
Kinetic Activity
Specific Activity
Protein Content and Uniformity
LAL (Bacterial Endotoxins
Sterility
Moisture Content
Osmolality
Particulates
pH
Western ID test
Reconstitution Procedure
SDS -PAGE Coomassie
ProteinConcentartion (UV Absorbance)
Demonstrated method troubleshooting capability
Knowledge, skills, and expertise in performing chemical experiments that involve the use of liquids, or "wet" chemicals
Raw Materials: techniques such as wet chemistry compendial testing.
Preparing chemical solutions, conducting chemical reactions, and analyzing chemical compounds using various wet chemical techniques such as titrations, extractions, filtrations, and precipitation
Qualifications:
Bachelor's Degree or superior
5 years of manufacturing, quality or engineering in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field
Strong understanding of the underlying principles of chemistry, as well as knowledge of laboratory safety and best practices
Strong experience with ICH Q2 method qualification/validation requirements
Strong experience with the USP, EP, and JP Pharmacopeia
Hands on analytical QC wet bench experience is preferred.
Hands on analytical instrumentation experience is preferred
Knowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control Laboratories, and experience with a wide range of analytical techniques.
Strong verbal and written communication skills
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