Pharma Process Development Scientist

Purdue Pharma; Wilson (NC); On-site; USD 120,000 - 170,000; Full time

Job summary

Knoa Pharma is seeking a senior scientist to manage transfer and validation of new products into production, oversee scale‑up and process development, and train production staff on new processes and equipment.

You will lead troubleshooting, reformulation efforts, and generation of validation protocols, while coordinating with engineering and production teams to ensure smooth technology transfer and product quality across the manufacturing floor.

Qualifications

• BS degree in Chemistry, Biology or Engineering with a minimum of 5-7 years’ experience in Pharmaceutical Product Development and/or Process Development; Master’s degree and 4 years of experience.

Responsibilities

• Coordinate scale-up batches of new products and processes including batch record prep, scheduling, raw material acquisition, supervising batch manufacture.
• Identify potential product/process improvements of existing dosage forms; present proposals to optimize formula and product flow and implement changes.
• Develop potential product/process activities for new products; present proposals to optimize formula and product flow.
• Provide technical assistance to Production to solve problems on the shop floor, including troubleshooting and potential rework procedures for failed batches.
• Evaluate and qualify alternate sources of raw materials; coordinate new equipment transfer and training for supervisors/operators.
• Coordinate protocols for process/product validation studies, including cleaning and equipment validation; prepare validation reports and data analyses.

Skills

Process development

cGMP

FDA/DEA regulations

Equipment operation

DOE

Batch manufacturing

Problem solving

Education

BS in Chemistry/ Biology/ Engineering

Master’s degree in relevant field

Tools

M.E.S. (SAP)

Job description

Knoa Pharma is seeking a senior scientist to manage transfer and validation of new products into production, oversee scale‑up and process development, and train production staff on new processes and equipment.

You will lead troubleshooting, reformulation efforts, and generation of validation protocols, while coordinating with engineering and production teams to ensure smooth technology transfer and product quality across the manufacturing floor.