Scientist - CMC

Chicago, IL 60616

Employment Type: Permanent Job Category: Chemist/ Lab Job Number: NA8615107314 Compensation: 80000

Job Description

Visa Sponsorship Not Available 
Kashiv BioSciences is a fully integrated biosciences company with an expanded and dynamic platform for growth including advanced drug delivery technologies, biosimilars, prodrugs, and a large development pipeline.
This is an exciting opportunity to be a key member of our CMC R&D team in Piscataway, NJ.
The Senior Scientist - CMC R&D will be responsible for developing study protocols, reports, BLA/IND sections, regulatory meetings packages, briefing books and any other R&D documents required for regulatory submissions and will be the key resource responsible to collaborate between R&D groups (process and analytical) and regulatory, develop documentation timelines and manage R&D submission documents. The role requires collaboration with scientists to write or review CMC study protocols and reports and drive CMC documentation (planning, authoring, reviewing and coordination).
Essential Duties & Responsibilities
  • Design and perform CMC studies, and coordinate with outside laboratories for testing/execution of studies
  • Authoring and reviewing CMC documentation based on CMC development work.
  • Identify the required documents and content, quality and/or timeliness issues for regulatory submissions in accordance with project timelines.
  • Author and review high-quality CMC documentation for regulatory authorities, ensuring technical congruency and regulatory compliance in the submission documents.
  • Manage the documentation and follow-up with the progress based on agreed upon timelines.
  • Identify critical aspects in documentation to ensure regulatory compliance.
  • Coordinate with regulatory department to ensure availability of right documents in timely manner.
Position Requirements and Qualifications
  • Master’s degree or higher in Biochemistry or related discipline.
  • Minimum of 2 years of experience required. Will consider Bachelors Degree with 3 years of experience.
Specialized Knowledge and Skills
  • Should have knowledge of process development for biologics/biosimilars with hands-on experience.
  • Should have broad analytical chemistry knowledge and hands-on experience with HPLC, UV, Mass Spec and Bioanalytical techniques.
  • Should have a strong understanding of ICH Guidelines, cGMP and FDA regulations, especially from a CMC perspective.
  • Should have the ability to manage and track project timelines.
  • Should have good verbal and written communication skills.
  • Attention to details and accurate record keeping.
  • Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.
  • Should be agile to take up various tasks and projects depending on company priorities.

Meet Your Recruiter

Herman Davis
Technical Recruiter

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