Please note that this is a 5 month contract assignment. Candidates cannot start an assignment until
background check and drug test is completed*
Tests and interprets results for raw materials, active pharmaceutical ingredients, finished pharmaceutical products, and stability samples. Interprets compendial and internal monographs, NDAs and Laboratory Quality Standards
Job Requirements
BS/MS in science, preferably in Chemistry or ...
Seeking a protein expert to lead a team focusing on the development of methods for characterizing proteins and protein based therapeutics. Shall be responsible for hands on method development and team leadership as well as IND and BLA contributions.
Requires PhD and hands on development experience with Liquid chromatography - Mass Spectrometry and two dimensional Gel Electrophoresis for characterizing proteins
Highly visible associate director level position with a leader in the scientific ...
Hands on team leadership opportunity to develop protein purification and characterization processes to support biologics manufacturing of Monoclonal Antibodies, Enzymes, Growth Factors, PEGylated Proteins and Cytokines derived from mammalian cell lines
Will:
*** Develop new purification procedures to be transferred and scale up to clinical and commercial manufacturing
*** Evaluate transferred processes, validate existing procedures, ensure viral validation, and train manufacturing team on new ...
Responsibilities:
**This is position requires frequent 3pm - 11pm shift coverage. The employee will primarily work M-F, 8am - 5pm, but must have the ability to cover 3pm - 11pm for weeks at a time. Please make sure candidates have this availability!**
• Perform batch record review concurrent to completion of manufacturing operations in real time.
• Perform routine quality audits in Manufacturing.
• Support quality systems related to QA for in-process sampling and controls, and all aspects of shop ...
Description
This position will support the organization of the QC Biochemistry laboratory at the Flu Cell Culture facility in Holly Springs, NC. Primary responsibilities for this position include GMP testing support for biochemistry assays (SDS-PAGE, Threshold, SRD and UV/Vis spectrometry), stability testing, laboratory data review and some participation in method validation and transfer. The QC Analyst I may be identified as a Subject Matter Expert (SME) for biochemistry assays within the ...
Responsibilities:
• Supports the implementation of necessary Novartis V&D Quality processes, systems, and procedures regarding self-inspections and general compliance at Holly Springs, N.C.
• Act as lead auditor during self-inspections (including all prep, day of and follow up activities
• Complete general compliance activities including but not limited to regulatory gap assessments and SOP revisions
• Reports monthly KPI/KQI’s for self-inspections.
Requirements:
• Must have experience leading, ...
Lead the development of preclinical and clinical strategies based on the discovery of molecular biomarkers to drive the creation of novel oncology therapeutics
Shall:
*** Prioritize and evaluate predictive biomarkers and companion diagnostics to optimize clinical development
*** Collaborate with scientific experts to establish accurate and reliable criteria for proof of mechanism and integrate study results into the clinical development strategy
*** Determine the role of predictive biomarkers ...
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