Pharmaceutical Technology Scientist (Manufacturing Sciences)

About the role

Knoa Pharma is a public health-driven pharmaceutical company focused on addressing the opioid crisis. We develop and produce lifesaving medications and treatments for opioid use disorder, supported by a not-for-profit foundation.

Responsibilities

• Coordinate scale-up batches of new products and processes, including batch record preparation, scheduling, raw material acquisition, and supervision of batch manufacture.
• Identify and propose improvements to existing commercial dosage forms, and implement these changes after management approval.
• Develop and execute proposals for new product/process activities, optimizing formulas and product flows.
• Provide technical assistance to production staff, solving problems on the shop floor and developing rework procedures for failed batches.
• Evaluate and qualify alternate sources of raw materials.
• Maintain compliance with controlled substance documentation and accountability procedures, ensuring low risk of diversion and theft.
• Coordinate, develop, and prepare protocols for process/product validation studies, including cleaning and equipment validation.
• Prepare validation reports, including data analysis, conclusions, and recommendations.
• Execute validation studies with production scheduling, and review and execute protocols developed by others.
• Perform other related assignments and duties as required and assigned.

Requirements

• 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 preferred.
• Advanced knowledge of process development methodologies, including current validation concepts, with a strong understanding of cGMP requirements and FDA and DEA regulations.
• Demonstrated expertise in operating and overseeing pharmaceutical production equipment, including high-shear granulators, fluid bed processors, solution preparation systems, weighing and dispensing systems, milling and blending equipment, tablet compression machines, and encapsulators.
• Comprehensive knowledge of pharmaceutical unit operations, particularly as they relate to solid oral dosage forms.
• Proven capability to develop original, data-driven solutions to optimize formulations and manufacturing processes.
• Strong capability in protocol development, including selection of appropriate study designs to demonstrate process consistency and product acceptability.
• Proficient in preparing technical reports, including analysis and interpretation of data against specifications and acceptance criteria.
• Ability to investigate, document, and justify all process deviations, discrepancies, and variations.

Qualifications

• Advanced knowledge of process development methodologies, including current validation concepts, with a strong working understanding of cGMP requirements and FDA and DEA regulations.
• Demonstrated expertise in the operation and oversight of pharmaceutical production equipment, including high-shear granulators, fluid bed processors, solution preparation systems, weighing and dispensing systems, milling and blending equipment, tablet compression machines, and encapsulators.
• Comprehensive knowledge of pharmaceutical unit operations, particularly as they relate to solid oral dosage forms.
• Proven capability to apply sound scientific judgment and make timely decisions during process development, design of experiments (DOE), and batch manufacturing activities.
• Strong capability in protocol development, including selection of appropriate study designs to demonstrate process consistency and product acceptability.
• Proficient in the preparation of technical reports, including analysis and interpretation of data against specifications and acceptance criteria.
• Ability to investigate, document, and justify all process deviations, discrepancies, and variations.