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 in order to deliver the prototypes of dosage forms from new chemical. Specifically, the incumbent will be responsible for preclinical through early clinical formulation and manufacturing process design and manufacturing of solid, liquid and semi-solid dosage forms for new drug candidates.
Applicant must be legally authorized to work in the US.
- Conduct formulation development and optimization studies for solid, semisolid, liquid dosage forms including but not limited to the powder blends, granulations, tablets, capsules, solutions, suspensions, and dispersions by utilizing QbD principles.
- Accountable for process optimization and scale-up activities, and technology transfer to scale-up manufacturing sites.
- Present the purpose of experiments and experimental results and define the 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.
- 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 0 year or MS with 5 years of industry experience.
- Extensive experience in preformulation studies, formulation design and process development. Solid understanding of the application of principles of physical chemistry, pharmaceutics, and biopharmaceutics. Familiar with the state-of-art technologies to develop various dosage forms and drug delivery systems including solid oral dosage forms, semisolids, liquids and suspensions. • Hands-on 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 pharmaceutical analysis, familiar with the method development and instruments used in preformulation and formulation studies.
- A thorough understanding of cGMP, regulatory and safety requirements.
- Self-motivated and organized. 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.
- Ph.D. in Pharmaceutics, Chemical Engineering, or allied disciplines.
- Previous experience in product development for preclinical and FIH studies.
- Experience in analytical method development is a plus.