Band

Level 2

Job Description Summary

Production Technician plays an active role in daily production of Radioligand Therapies (RLT) as well as setup and preparation of instruments and equipment. The Production Technician adheres to regulatory requirements while performing job functions, executing production as per batch records and SOPs. Responsibilities are performed within a team and according to an assigned production shift schedule. The Production Technician works closely with the Manager and Lead to ensure production is executed in a safe and timely manner.

Job Description

Major accountabilities:

• Executes all activities related to the manufacturing of RLT products. Responsibilities include operating and maintaining grade A isolators, focusing on KPI goals as well as ensuring all state, federal and Novartis radiation safety guidelines are adhered to.

• Responsible for successful on time completion of required training curriculum comprising of the necessary Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE for the specific role.

• Supports all technical aspects related to production readiness including manually cleaning the cell and performing sterilization of the isolators using vaporized hydrogen peroxide.

• Conducts routine and dynamic environmental monitoring as required.

• Prepares all materials while maintaining material identity in accordance with the batch monitoring system as defined by procedure.

• Participation in assigned qualification/validation activities, as necessary.

• Facilitates a culture of “speaking up” and ensuring all cGMP compliance activities are followed.

• Prepares applicable documents and records such as batch records, shipping documents, and training materials.

• Given the time sensitive nature of the product, this position will require unplanned overtime to ensure process continuity and completion.

• Other duties may be assigned, as necessary.

Key performance indicators:

• Right First Time Batch Record execution. No recurrent deviations.

• Adherence to Attendance Guidelines and all Safety related procedures

• No major or critical audit findings pertinent to the Grade A isolators or Grade B/C areas.

• Manufacturing compliance/adherent to all GDP/GMP principles

• Aseptic/CleanroombehaviorinaccordancewithGMPguidelines

Minimum Requirements:
Specific Professional Competencies：

• Flexibility to don clean room garments and personal protective equipment (PPE).

• Near vision performance should be the equivalent of 20/20 with no impairment of color vision. The use of corrective lenses to achieve the desired visual acuity is permitted.

• Makeup, jewelry, nail polish, perfume/cologne and other potential microbial sources are prohibited in restricted areas.

• Ability to lift or carry up to 35 pounds.

Education:

• Bachelor of Science strongly preferred. If the applicant does not have a degree, a minimum of 2 years of experience in a cGMP or aseptic environment is required.

Languages:

• Proficiency in Chinese; preferably to use English as working language

Experience / Professional requirements:

• Internal candidates: Has been a Production Technician for a minimum of 12 months including prior RLT experience and are qualified in at least two critical production isolator tasks

• External candidates: 2-4 years of experience in aseptic pharmaceutical manufacturing. Preferably in drug product filling operations.

• Knowledge of cGMP regulations and FDA guidance applicable to aseptic manufacturing.

• Proficient in MS Office applications.

Skills Desired

General Hse Knowledge , gmp knowledge