Sterling Engineering, Inc. https://cdn.haleymarketing.com/templates/63335/logos/square_logo.png https://www.sterling-engineering.com https://www.sterling-engineering.com USD 80000 YEAR true
Scientist - CMC
Chicago, IL 60616 US
2023-03-15 2023-04-22 Employment Type: Permanent Job Category: Chemist/ Lab Job Number: NA8615107314 Compensation: 80000
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.