What are the responsibilities and job description for the QC Chemist position at IT Minds LLC?
QC Chemist
Northern, NJ
Background: Our client is looking for a QC Chemist to help support their QC lab at a new R&D facility in New Jersey.
Project: Our client is looking for someone coming from a GMP/large molecule background with a least five years of experience to support qualification, method validation, HPLCs, UPLCs, developing test methods, commissioning, and analytical methods. It is a start up site so looking for someone who can be a self starter and bring their experience to the bench, while maintaining a positive attitude.
Required Skills:
- **Occasional weekend hours on Saturday depending on lab activities, nothing consistent or scheduled but just as needed to hit deadlines**
- At least 5 years of experience
- Biologics/large molecule background (monoclonal antibodies)
- HPLC, protein A HPLC
- Size exclusion chromatography
- Peptide mapping
- N-glycan (analytical chemistry method)
Essential Functions of the job:
- Lead and execute QC chemistry assay validation and transfer activities, including testing (e.g., DS, DP release and stability testing) to ensure timely generation and reporting of test results in support of manufacturing operations.
- Support routine operations, including but not limited to leading instrument qualification and maintenance, SOP generation and revision, specification generation and revision, testing record keeping, etc.
- Manage inventory of reagents and supplies for the laboratory.
- Lead laboratory investigations, including but not limited to OOS, Out of Trend, deviations, invalid assays, and associated corrective actions.
- Lead method transfer and method validation activities, including protocol preparation, protocol execution, and report preparation.Working knowledge and experience in an FDA-regulated biotechnology, pharmaceutical company are required.
- Working knowledge and hands-on experience with Chemistry analytical methods for biological products (monoclonal antibodies), such as HPLC, UPLC, Container Closure Integrity (CCIT), Sub-visible Particles, N-glycan, UV spectrophotometer, including qualification, assay validation and transfer activities
- Knowledge with USP/EP and cGMP/EU GMP, and ICH guidelines.
- Lead instrument and equipment validation
Best Regards,
Satya Satish J | Technical Recruiter | IT Minds LLC |
Phone: 949.561.0655 | Email: satish.j@itminds.net |
