Pharmaceutical Development Technician, Clinical Supply Planning & Operations

Role Summary

Temporary 6-Month Position - Pharmaceutical Development Technician, Clinical Supply Planning & Operations. The goal of Pharmaceutical Development within Research & Development is to develop new drug candidates and the processes to manufacture them into commercial realities. This role involves designing and conducting experimental studies, working in both laboratory and process scale-up facilities, with strict adherence to cGLP/GMP and regulatory requirements. Collaboration with professional and union staff is essential, and daily assignments are based on demonstrated technical competence and process demands.

Responsibilities

• Weigh, dispense and accurately label bulk drug substances, ingredients, dosage forms, packaging components, and all materials needed to support clinical programs and product development
• Withdraw samples from material containers, transfer materials between buildings and within buildings by means of hand trucks or forklifts
• Set up, clean and operate all areas and equipment required in the weighing and dispensing process
• Record data per cGLP and cGMP regulations in paper and computer formats per established procedures
• Maintain the warehouse, dispensaries and other operations areas in neat and tidy conditions
• Perform receipt, reconciliation and put-away of inbound materials
• Pack and ship regular and temperature-controlled shipments domestically and internationally
• Perform physical and system pick of finished clinical supplies for domestic and international shipments
• Pack finished clinical supplies for domestic and international shipments and maintain temperature controls according to cold chain guidelines
• Perform inventory/cycle counts of finished supplies; re-labeling activities and shipment labeling

Qualifications

• Two year Associate Degree in Science related to Pharmaceutical Development or Business related to Operations/Supply Chain/Logistics or equivalent
• Proficiency in the use of computer programs/systems is essential
• Technicians must maintain their skills and knowledge current with advances in the field; may attend internal or external training as approved

Skills

• cGLP/cGMP knowledge and adherence to regulatory requirements
• Strong documentation and data-recording abilities
• Collaborative teamwork across professional and union staff
• Operations, logistics, and warehouse management

Education

• Two year Associate Degree in Science or related field

Additional Requirements

• Work may involve hazardous chemical, radiological, or biological agents; compliance with safety procedures and use of protective equipment is required
• May require work in laboratory, warehouse and process scale-up facilities; varies by assignment