Scientist I-Data Review, Analytical Development 2022 - 145
at Mirati Therapeutics Inc
San Diego, California, USA - 92121
|Start Date||Expiry Date||Salary||Posted On||Experience||Skills||Telecommute||Sponsor Visa|
|Immediate||13 Feb, 2022||Not Specified||15 Nov, 2021||2 year(s) or above||Good communication skills||No||No|
Required Visa Status:
|US Citizen||Student Visa|
|OPT||H4 Spouse of H1B|
|GC Green Card|
|Full Time||Part Time|
|Permanent||Independent - 1099|
|Contract – W2||C2H Independent|
|C2H W2||Contract – Corp 2 Corp|
|Contract to Hire – Corp 2 Corp|
JOB DESCRIPTION SUMMARY
The individual will be responsible for the review of any documentation associated with the release and stability data of drug substance and drug product. He/she will provide support for GMP data review of clinical, registration, and commercial batches, as well as GLP data review of batches used in GLP toxicology studies.
How To Apply:
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- Review all raw data (notebooks and chromatograms) for adherence to methods and testing protocols. Communicate any deficiencies to the laboratory and partner to resolve any issues.
- Review CoAs and stability reports for completeness and correct information compared to the raw data.
- Post CoAs and populate trackers internally as appropriate.
- Trend and track the data to highlight during review if there are any OOT results or any significant changes observed during stability studies that have not been already noted.
Hybrid role - can work from home a few days and be in the office a few days a week.
Pharma / Biotech / Healthcare / Medical / R&D
San Diego, CA, USA