J-Star research, Inc. is the Contract Development and Manufacturing Organization (CDMO) focusing on drug substances 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.
The primary role responsibility is to apply technical knowledge in manufacturing and release of quality drug products for clinical studies
Responsibilities:
- Hands-on experience working on equipment used for wet/dry granulation, FBD, tablet press, coater, automated capsule filler, spray dryer, hot melt extruder (HME) & others.
- Experience in scaling up products from lab scale to GMP scale for production & release of clinical trial material.
- Prepare, and review protocols, batch manufacturing records, SOPs
- Assist in GMP lab suite check out, clean out and check in processes.
- Responsible for documenting all batch manufacturing data generated as per GMP regulations.
- Good understanding of ICH, cGMP and regulatory requirements
- Work closely with QA, QC, Maintenance & other groups and maintain GMP production facility for compliance.
- Become proficient in all non-GMP and GMP SOPs
- Assist in the evaluation of production/processing equipment or fixtures for purchase and gathers data relating to their ability to meet organizational needs.
- Present the project technical findings to senior management and cross-functional team within the company and/or to the company’s clients.
- Assist in overall upkeep, maintenance, organization and housekeeping of GMP suites.
- Assist in work to trouble-shoot, maintain, repair, purchase, replace and install drug product manufacturing related equipment and services.
- Perform all job responsibilities with an uncompromising adherence to appropriate PPE utilization, safety and professionalism.
- Complete, understand and acknowledge all J-Star assigned and required training by due dates.
- Follow all company, site and laboratory Environmental, Health and Safety (EHS)-related protocols, processes, guidelines and SOPs. Actively participate in EHS discussions with peers and management for continuous improvement of EHS practices.
- Perform other job-related duties and ad hoc facility-related projects as assigned by manager.
Qualifications:
- Degree in Pharmaceutics, Chemical Engineering, or allied disciplines, Ph.D. with 2 years or MS with 4 years or BS with 5 years of industry experience in GMP drug product manufacturing of OSDs preferred.
- Familiar with the DP manufacturing facility and equipment qualification, maintenance, and cleaning.
- Previous experience working in a CDMO preferred.
- Ability to prepare, review and execute GMP documents.
- Extensive knowledge of USP, ICH, FDA, 21 CFR and other guidance documents
- Ability to interact in an effective and appropriate manner with diverse population sets.
- Ability to perform the physical requirements of the position. Must be able to walk, stand, crawl, stoop, crouch, bend or reach above and below shoulders height frequently. This job requires twisting and turning of the body and the use of both hands
- Excellent communications skills (verbal, written, and presentation skills). Must be organized and detailed-oriented.
- Must be a self-starter, self-motivated.
- Ability to prioritize & manage multiple projects simultaneously.
- Proficient in Microsoft Office and other job-related software and applications.
How to Apply:
- Applicants must be able to work legally in the U.S.
- Email resume to resumes@jstar-research.com. Include the job title of the position you are applying for in the subject line.
Job Location: Cranbury