Pharmaceutical Technology Scientist; Manufacturing Sciences

Overview

Join Knoa Pharma. Knoa Pharma is a public health-driven pharmaceutical company dedicated to addressing the opioid crisis. Our focus is on expanding access to lifesaving overdose reversal medicines and affordable treatments for opioid use disorder. Owned by a not-for-profit foundation, everything we do is centered on improving public health, saving lives, supporting recovery, and bringing forward medicines that make a meaningful difference.

Knoa Pharma has a robust generics and branded portfolio of medicines in development to address unmet medical needs, and it supports public health initiatives to address the opioid crisis. Its public health-minded purpose enables the company to expand access to lifesaving opioid overdose reversal medicines and affordable treatments for opioid use disorder – at no profit.

Job Summary Primarily responsible for transfer and validation of new products/processes into production, scale-up/manufacturing development, product transfer, and optimization. The major objective is to ensure successful new product transfer to production and proper training of production personnel in any new process and/or equipment. Key objectives include troubleshooting and reformulation of problem products, providing technical expertise and support to production quality investigations.

Other key objectives include generation, execution, and reporting of products, cleaning, and equipment validation protocols. Additional objectives include new production equipment selection and evaluation, rework evaluation of rejected batches and new/existing raw material evaluation.

• Coordinate the scale-up batches of new products and processes including batch record preparation, scheduling, raw material acquisition, supervising batch manufacture, etc.
• Identify potential product/process improvements of existing commercial dosage forms. Present proposals to optimize formula and product flow and implement changes after management approval.
• Responsible for development of potential product/process activities for new products. Present proposals to optimize formula and product flow.
• Provide technical assistance to Production, as needed, to solve problems on the shop floor. This includes troubleshooting of active products and potential rework procedures for failed batches.
• Responsible for new equipment evaluation. Interface with engineering and equipment manufacturers to ensure proper installation and operation of the new equipment. Coordinate activities to transfer new equipment to production, including training for supervisors and operators.
• Evaluate and qualify alternate sources of raw materials.
• Maintain compliance with Controlled substance documentation and accountability procedures while minimizing diversion and theft risks.
• Coordinate, develop and prepare protocols for process/product validation studies, including cleaning and equipment validation.
• Prepare validation reports, including data analysis, conclusions and recommendations.
• Coordinate the execution of validation studies with production scheduling; may review and execute protocols developed by others.
• Perform other related assignments and duties as required and assigned.

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

• 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. Ability to direct batch manufacturing activities, ensure compliance with SOPs and safety standards, and provide hands-on guidance to production operators.
• Comprehensive knowledge of pharmaceutical unit operations,…