GMP Aseptic Operator

About Ascendia Pharmaceutical Solutions:

Ascendia is a specialty pharmaceutical CDMO company dedicated to developing enhanced formulations of existing drug products, and enabling formulations for pre-clinical and clinical stage drug candidates. Ascendia specializes in creating formulations for poorly-water soluble molecules using nano-particle technologies. Ascendia assesses the feasibility of a broad array of formulation options in order to improve a drug’s bioavailability and solubility. Ascendia’s technologies include nano-emulsions, amorphous solid dispersions, nano-particles, injectable, and controlled release. Ascendia provides development, manufacturing, and testing services - from discovery-stage molecules to life-cycle-management projects - creating formulation solutions with enhanced biopharmaceutical properties suitable for clinical scale-up.

The mission of our company is to provide customized formulation solutions to “salvage” difficult compounds and to create advanced medicines to help patients “prevail” over their disease and enhance quality of life.

About the Position:

Perform manufacturing tasks: operate and perform on equipment used in the aseptic manufacturing unit processes. Perform the weighing of manufacturing ingredients, the manufacturing of the intermediate formulation, and the fill & finish of sterile dosage forms. Tasks include documentation including data entry and documents and/or use of computer systems. Comply with written procedures and Good Manufacturing Practices. Participate in Safety and Environmental inspections and audits. Perform reconciliation of materials and the inventory control using computerized system. Incumbent must be willing and available to work in rotating shifts, extended periods, and/or overtime when required.

Duties & Responsibilities:

Manufacture batches on pharmaceutical manufacturing equipment per written batch record procedures, including product sampling and evaluation of in-process data

Assists in the maintenance of manufacturing equipment,

Assembles and disassembles mechanical equipment to execute cleaning tasks and process, as required.

Cleans equipment, and maintains facility, according to establish procedures and records required information in appropriate logbooks.

Records and maintains the accountability of APIs, excipients, and components throughout the manufacturing process including returns of materials and appropriate disposal of waste in the respective designated areas..

Completes documentation quickly and efficiently, following good documentation practices, cGMPs and SOPs.

Weighs ingredients to be used in the manufacturing of product, including activities related to active ingredients like sieving, subdivision and intermediate and final formulation.

Complies with standard operating procedures, batch records, production records, sheets, checklist and process related documentation.

Complies with all the training required to perform the tasks, including SOPs, forms, guidelines, Safety and Environmental training.

Uses the personal protective equipment (PPE) required for the process or task to be performed. Uses the PPE in the right way, according to SOPs, Safety guidelines and training. Maintains the PPE in good conditions.

Comply with all safety and environmental guidelines, procedures, training, practices, permit conditions, and internal notifications of any environmental and or safety events

Performs other related tasks as required.

Requirements:

High school diploma is required

Bachelor Degree from an accredited institution is preferred.

Minimum of one year of experience in aseptic pharmaceutical manufacturing required.

Experience in manufacturing and/or materials handling process is required, including previous experience working with sampling plans, cGMP documentation and accountability of components, materials and product.

Knowledge and experience working in a GMP environment, with good documentation practices, as well as product sampling and inspection.

Able to read, write and speak English

Knowledge basic computer software: Word, Excel, Power Point, and other if desirable.

Good communication skills, both verbal and written. Able to document legible, precise and clear in documents following good documentation practices and cGMPs

Pay: $20.00 - $28.00 per hour

Expected hours: 40.0 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Safety equipment provided
• Vision insurance

Work Location: In person