QC Test Method Engineer
2 weeks ago
From Discovery to DeliveryTM, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs. From Azzur Cleanrooms on DemandTM 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
- Knowledge, skills, and expertise in performing chemical experiments that involve the use of liquids, or "wet" chemicals
- Execute test method transfers/validation/verification protocols for one or more of the following:
- Appearance
- Lab assay execution
- 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
- Protein Concentration (UV Absorbance)
- Demonstrated method troubleshooting capability
- 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
- Prefer knowledge with KNEAT software
- 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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