Newark Metro Area, NJ
This position focuses on the daily operations and activities within the Drug Product Development Process area, which includes preparation and operation of lab and pilot scale solid dose process equipment. Candidate will work under the direct supervision of the DPD Operations Lead Technician or Associate Manager. Responsibilities include cleaning of process area rooms, process isolators and process equipment. Additional responsibilities will inclde weighing and dispensing of raw materials, executing batch processes, setting, operating of process equipment according to established procedures and under supervision.
The Associate Technician will also accurately document all activities in batch records, notebook entries, equipment cleaning and use logs, or other worksheets. Associate Technician supports activities as directed by the weekly area schedule or Associate Manager s directions. Candidate will stock and maintain inventory of consumables, supplies, and Personal Protective Equipment. Associate Technician will also support process activity work and equipment set-ups with formulation scientists, process engineers, lab support and maintenance / calibration personnel.
Candidate must be detail oriented, capable of working hands-on , and possess mechanical aptitude. Candidate must also have good communication skills and have the ability to successfully interact with internal and external partners.
Responsibilities will include, but are not limited to, the following:
Assists with the daily operations of the Drug Product Development (DPD) Facility.
Under direct supervision of the Lead Technician or Associate Manager, the Associate Technician prepares and operates equipment for batch processing per established procedures. AT also completes subsequent equipment and area cleaning activities per established procedures.
Under general guidance, executes experiments / completes batch records and documents results using Good Documentation Practices.
Follows weekly process schedule for DPD Process Facility.
Stocks consumables, materials and PPE supplies inventories.
Under general guidance, responsible for equipment and facility / containment apparatus cleaning and sanitizations.
Ability to identify and report problemconditions to Sr. Tech / Associate 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.
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.
HS Diploma or Trade Certificate with minimum 4 years relevant experience.
Associates Degree with minimum of 2 years relevant experience,
Bachelor of Science Degree required in Pharmaceutical Science, Engineering or equivalent discipline preferred.
Relevant experience in Oral Solid Dosage Development, GMP Process, Facilities and Operations.
Ability to work in isolator / containment apparatus, or while gowned with personal protective equipment.
Ability to lift up to 80 lbs.
Ability to communicate effectively (oral & written).
Demonstrates good equipment, process and problem solving capabilities.
Hands-on experience and mechanical aptitude skills required.
Ability to work extended hours, overtime, additional shifts in support of schedule and departmental objectives if required.
Proficient with computer software programs / applications.
Demonstrates initiative for advancement within department / organization.