What are the responsibilities and job description for the Senior/Principal ARD Scientist position at Kashiv BioSciences, LLC?
Description
Maximise your chances of a successful application to this job by ensuring your CV and skills are a good match.
The Senior / Principal Scientist will be part of the CMC ARD team responsible for drug product related CMC strategy development for clinical stage biosimilar and conjugate biologics programs. The individual will be proficient in multiple analytical techniques as well as with the latest ICH, FDA and EMA regulatory guidance on pharmaceutical development. A successful candidate will act as an intellectual resource in area of expertise by supporting analytical method development, tech-transfer, and validation.
Key responsibilities include :
- Provide scientific guidance and leadership on phase appropriate methods development, optimization, qualification, technical transfer, product comparability, extended characterization, and stability programs.
- Conduct characterization, investigation, and troubleshooting to provide key insights and understanding for drug product CQA assessment.
- Work on analytical method development , optimization, troubleshooting, qualification, and validation : LC (SEC, RP, IEX, HIC etc.), mass spectroscopy, capillary electrophoresis, MALS, and other large molecules characterization methods.
- Author experiment summaries, development reports, technical reports , operation and test method procedure documents, and provide review for documents comprising, but not limited to standard operating procedures, standard test methods, validation protocols and reports, etc.
- Actively participate in project team meetings , and communicate scientific data and concepts effectively through presentations, posters, and reports.
- Stay well-informed with advancements in separation sciences and large molecule characterization tools, and attend / present at scientific conferences.
- Communicate effectively with supervisors, colleagues, clients, and vendors.
- Maintain accurate, detailed, and timely records of method development and analytical data.
- Perform data review to ensure accuracy, completeness, and validity.
Requirements
Experience and Skills :
WORK ENVIRONMENT AND PHYSICAL DEMANDS :
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