Manager – GMP Drug Product Manufacturing

J-Star research, Inc. is the 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.

The primary role responsibility is to establish and maintain GMP drug product manufacturing capabilities for small molecule oral solid dosages (OSD) initially, which may expand to other new modalities and dosage forms; build up manufacturing workflows and manage production, facility and equipment planning, etc.

Responsibilities:

• Establish GMP drug product manufacturing system, including but not limited to qualify the facility, procure and perform IQ/OQ of equipment, establish appropriate procedures for maintaining high standards.
• Manage the manufacturing activities to ensure that all products conform to established customer and company quality standards.
• Hands on experience with spray dryer, HME & other tablet, capsule manufacturing equipment
• Ensure all GMP planning, manufacturing, cleaning, and storage operations run efficiently.
• Author/review/approve BMRs, SOPs, & other quality documentation according to regulatory guidelines.
• Work with R&D scientists to ensure smooth technology transfer of R&D processes into the GMP manufacturing suites.
• Collaborate closely with QC, QA, Maintenance & other groups to ensure timely production & release of clinical trial materials.
• Perform root cause investigations, risk management, deviations, CAPAs as required.
• Identify, recommend, develop and implement necessary changes, within the appropriate regulatory confines to improve productivity and for continuous process improvements.
• Adhere to EHS policies and maintain work areas in a safe, clean and orderly fashion.
• Ensure the training program for all levels of manufacturing are current and complete and production personnel are qualified to perform work assigned.
• Ensure a rigorous preventative maintenance schedule is implemented and sustained for all GMP equipment and instrumentation.
• Work with other departments to procure equipment and build new processes.
• Establish appropriate raw material inventory levels to meet manufacturing expectations and goals.
• Perform other duties may be assigned by the supervisor.

Qualifications:

• Advanced degree in Pharmaceutics, Chemical Engineering, or allied disciplines, Ph.D. with 8 years or MS with 10 years or BS with 12 years of industry experience GMP drug product manufacturing of OSDs preferred.
• Extensive experience in GMP manufacturing of OSDs for early and late stage       clinical studies required. 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
• Excellent communications skills (verbal, written, and presentation skills). Must be organized and detailed-oriented.
• Must be a self-starter, self-motivated.
• Ability to manage a team and make recommendations to management.
• 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.