J-Star Research, Inc. is a Contract Development and Manufacturing Organization (CDMO) focusing on drug substance and drug product development and optimization. Our integrated solutions offer a unique set of services for the new drug candidates from drug discovery to drug product development for preclinical and Phase I clinical studies.
The primary role responsibility is to perform preformulation studies, formulation and process development, optimization, scale-up and manufacturing in support of J-Star’s drug product development projects. The incumbent should provide the expertise in drug product formulation and manufacturing process development to deliver the prototypes of dosage forms for NCEs and other small molecules. Specifically, the incumbent will be responsible for preclinical through early clinical formulation development, process design and manufacturing of oral solids, liquids, injectables and semi-solid dosage forms for new drug candidates.
- Conduct formulation development and optimization studies for oral (tablets, capsules, solutions, suspensions), injectables and semisolid dosage forms by utilizing QbD principles.
- Develop analytical methods to support drug product development as required, characterize drug substances and products using scientific principles.
- Present the project technical findings, design space to senior management and cross-functional team within the company and/or to the company’s clients.
- Responsible to document all data generated in the laboratory notebooks. Prepare, review, and/or approve protocols, updates, master batch records, development reports, CMC regulatory documents, and SOPs.
- Accountable for process optimization and scale-up activities, and technology transfer to scale-up manufacturing sites.
- Experience using statistical experimental design software and analysis
- Good understanding of ICH, cGMP and regulatory requirements
- Participate in maintaining high quality laboratory environment and comply with Health, Safety and Environmental responsibilities for the position.
- Perform other assignments as required to meet company objectives.
- Advanced degree in Pharmaceutics, Chemical Engineering, or allied disciplines, Ph.D. with minimum 1-3 years or MS with 3-5 years of industry experience.
- Experience in preformulation studies, drug enabling technologies – Spray drying, HME
- Hands-on experience in oral drug product manufacturing unit operations including blending, wet- and dry-granulation, milling, spray drying, fluid bed granulation, drying and coating, tableting, film-coating, and encapsulation.
- Hands-on experience in HPLC, DSC, TGA, XRPD, Rheometer
- A thorough understanding of cGMP, regulatory and safety requirements.
- Proactive in problem-solving. Ability to work independently and effectively, prioritize and manage multiple projects and activities, commit to the assignments in a timely manner.
- Excellent interpersonal, written, and verbal communication skills