- BioAgilytix (Durham, NC)
- … data , updating timeline, and notifying issues Prepare and review scientific training materialsTrain analysts/junior scientistsAssist with definition of project ... therapeutics to the patients who need them.Essential ResponsibilitiesServe as lead scientist on assay development, validation, and sample analysis project Follow … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …experimentsAuthor and review technical documents, protocols, and reportsAnalyze and present data in a clear and concise mannerEnsure GMP compliance in ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Scientist as part of the Global MSAT team based in Raritan, NJ.Role OverviewWe… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … review , and coordinate technical documents, protocols, and reportsAnalyze and present data in a clear and concise mannerEnsure GMP compliance in laboratory ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Senior Scientist as part of the Global MSAT team based in Raritan, NJ.Role OverviewWe… more
- Insmed Incorporated (San Diego, CA)
- …training in other AAV assays.Ensure the timely execution of all routine QC testing, data review , and preparation of summary reportsMay act as an analytical lab ... New York™, and Best Workplaces for Millennials™ lists.OverviewInsmed is seeking an QC Scientist 1 with broad knowledge and expertise in molecular biology assays and… more
- Insmed Incorporated (San Diego, CA)
- …Review batch records, SOPs, raw material specifications, and GMP protocols and author development reports.Demonstrate experience with process validation ... and engaged. If you are a driven and acute scientist who is motivated to bring life-changing medicine to...purification.Work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors;Author Standard… more
- Lundbeck (Bothell, WA)
- …development programs (from early to late phase clinical development) Author and review SOPs, development reports, and technical reports In partnership with QC, serve ... Expert (SME) in the transfer of analytical methods from Lundbeck to GMP contract labs/contract manufacturing organizations (CMOs) Collaborate with QC to ensure… more
- Insmed Incorporated (San Diego, CA)
- …protocols, and reports as needed Ensure the timely execution of all routine QC testing, data review , and preparation of summary reports May act as an analytical ... Software Use Expectations:o Utilize the LIMS system to submit samples, enter data , and track samples.o Utilize statistical analysis software to generate assay… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and executing post-approval Regulatory CMC strategies, reviewing CMC information and data , authoring CMC submissions, and interacting with Health Authorities to meet ... on Harmonization (ICH), and other applicable regulations. This includes preparation, review , and approval of CMC documentation for BLA Supplements (PAS, CBE-0,… more
- Catalent Pharma Solutions (Morrisville, NC)
- **Position Summary:** Catalent Pharma Solutions in Morrisville, NC is hiring a Scientist - Data Review for the Analytical Research and Development group. The ... customers and in collaboration with other Catalent facilities. The Scientist - Data Review will...and experience with Mass Spectrometry is strongly preferred + GMP Background is strongly preferred + Strong written and… more
- Catalent Pharma Solutions (Madison, WI)
- …while maintaining a GMP quality system. Other duties will include data review /archiving, database entry/ review and contributions to process improvement ... ** Scientist I, Quality Control** **M-F 8am-5pm** **Summary:** _Catalent...technical documents such as SOPs and reports. + Performs self- review of analytical data for accuracy and… more
- Catalent Pharma Solutions (Madison, WI)
- …testing with supervision. + Operates basic cGMP Quality Control equipment. + Performs self- review of analytical data for accuracy and consistency with SOP. + ... **Associate Scientist I, Quality Control** **M-F 8am-5pm** **Summary:** _Catalent...maintenance and basic laboratory maintenance activities while maintaining a GMP quality system **The Role:** + Executes and properly… more
- ThermoFisher Scientific (Boston, MA)
- …manage data and documents. This position will support QC activities, data review , document management, and maintain content aligns with source documentation. ... with QC test results + Participates in cross functional workstreams in analytical data review + Updates scheduling/planning/TAT of test results from CTL and… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …to achieve your own career goals. **Position Summary:** The Senior Principal Scientist will be an CMC analytical lead (CMC-AL) for drug candidates across ... controls adhering to ICH guidelines and Health Authority requirements. The Senior Principal Scientist will have a direct impact on the division and also influence in… more
- Gilead Sciences, Inc. (Foster City, CA)
- …manufacturing facilities as person-in-plant. Support manufacturing atypical event investigations. + Support non- GMP pilot lab operations. Review GMP and non- ... Join Gilead and help create possible, together. **Job Description** **Research Scientist , Purification Development - Pre-Pivotal Biologics - Foster City, CA** At… more
- Gilead Sciences, Inc. (Foster City, CA)
- …manufacturing facilities as person-in-plant. Lead manufacturing atypical event investigations. + Review GMP and non- GMP technical documentation (batch ... Gilead and help create possible, together. **Job Description** **Senior Research Scientist II, Purification Development - Pre-Pivotal Biologics - Foster City, CA**… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Design and conduct laboratory scale experiments; hands-on laboratory execution is expected. + Review GMP and non- GMP technical documentation (batch records, ... Gilead and help create possible, together. **Job Description** **Senior Research Scientist I, Cell Culture Process Development - Pre-Pivotal Biologics CMC… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead and help create possible, together. **Job Description** **Senior Associate Scientist , Cell Culture Process Development - Pre-Pivotal Biologics CMC Development ... and help create possible, together. **Job Description** The Senior Associate Scientist , Cell Culture Process Development (Pre-Pivotal) will lead and execute cell… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. **_Research Scientist , Biologics Quality Control- We are seeking several individuals to support ... our GMP , Operations and Logistics team, Analytical Lifecycle Management team,...samples, shipping, and testing logistics, reference standard inventories, and data entry from CTLs/CMOs into Gilead's LIMS. The role… more
- ThermoFisher Scientific (West Hills, CA)
- …with moderate complexity + Design, create and/or provide experimental tasks to designated Scientist or self and complete data analysis using uType, SureTyper, ... and other relevant data + Prepare accurate and timely reports to Scientist III/Management + If necessary, support their team as backup during supervisor absence… more
- Abbott (St. Paul, MN)
- …practices (GLP), and Good Manufacturing Practices ( GMP ) + Document, analyze, report, and review data in electronic lab notebook system + Adhere to all lab ... people in more than 160 countries. **Job Title** Sr. Scientist R&D **Working at Abbott** At Abbott, you can...Supervise or direct others day to day work + Review /Approve data + Author protocols/reports + Execute… more
