AddressRequired Visa Status:
| Citizen | GC |
| US Citizen | Student Visa |
| H1B | CPT |
| OPT | H4 Spouse of H1B |
| GC Green Card |
Employment Type:
| Full Time | Part Time |
| Permanent | Independent - 1099 |
| Contract – W2 | C2H Independent |
| C2H W2 | Contract – Corp 2 Corp |
| Contract to Hire – Corp 2 Corp |
Description:
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.
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 skill
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
- Protein Concentartion (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
