Seeking to hire a Technician for the Formulation Lab area with oral solid dosage development and operations experience for GMP and non-GMP processes.
•Assists with the daily operations of the Drug Product Development (DPD) Facility.
•Under minimal supervision of the Lead Technician or Supervisor, the Technician prepares and operates equipment for batch processing per established procedures. Technician also completes subsequent equipment and area cleaning activities per established procedures.
•Under generatl supervision, executes experiments / completes batch records and documents results using Good Documentation Practices.
•Supports Formulation Scientists in design of process and experiments. Effectively communicates results.
•Follows weekly process schedule for DPD Process Facility.
•Stocks and maintains consumables, materials and PPE supplies inventories.
•Responsible for equipment and facility / containment apparatus cleaning and sanitizations.
•Interfaces with lab support staff, maintenance and calibration personnel in support of department operations.
• Coordinates equipment repair / preventative maintenance / calibration activities with process schedule.
•Capability to troubleshoot and report problem conditions to Lead Tech / Manager.
•Capable of complying with all departmental objectives – Environmental Health and Safety, budget, purchasing, and procedural direction compliance.
•Capable of working with potentially hazardous material in isolator / containment and / or gowning with personal protective equipment.
•Ability to lift up to 80 lbs when required in support of equipment set-up and cleaning.
•Assists with preparation of equipment for installation into the facility. Assists with execution of qualification activities (IQ/OQ/PQ).
•Provides input for development of Standard Operating Procedures in support of department’s objectives.
•Works effectively with internal and external resources as necessary in support of department objectives.
•Supports packaging and labeling of materials for stability, shipment or other purposes. Ensures timely delivery of sample materials for further processing.
HS Diploma or Trade Certificate with minimum 6 years relevant experience.
Associates Degree with minimum of 4 years relevant experience,
Bachelor of Science Degree with minimum of 2 year relevant experience,
required in Pharmaceutical Science, Engineering or equivalent discipline preferred. Relevant experience in Oral Solid Dosage Development, GMP Process, Facilities and Operations with a strong understanding of Spray Drying Equipment and Liquid Compounding Equipment.